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Pharmaceuticals manufacturer Hovione has been awarded a Medal of Merit for industry and commerce in the government’s 2023 honours list, with Chief Executive Ho Iat Seng praising the company’s contributions to Macao’s emerging life sciences industry. The Portuguese company’s Macao site manager, Eddy Leong, said in a statement that it was a “great honour” to receive the Medal of Merit – which he saw as a tribute to almost 40 years of local work in the science sector. “At Hovione, we like to say that we are ‘in this for life’ and I feel that this award reflects not only our long and successful history in Macao, but also points to our successful future here,” he said.  “It also reflects our commitment to work with partner organisations to create rewarding career opportunities in life sciences,” Leong added. Hovione was founded in 1959 in Portugal and opened its Macao plant in the mid-1980s. The facility produces generic active pharmaceutical ingredients and is located in Taipa, on the site of the old Him Un Iec Kei Chan firecracker factory. Other 2023 honourees include wushu athlete and Asian Games gold medalist Li Yi, who received a Silver Lotus, and the Portuguese-language educator Felizbina Carmelita Gomes – currently director of the D. José da Costa Nunes Kindergarten. Gomes was awarded a Medal of Merit for education.   Read more at Macao News  

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Hovione ‘delighted’ by its Medal of Merit

Dec 27, 2023

Hovione has acquired start-up company, ExtremoChem, expanding its technology platforms.   Specialist integrated contract development and manufacturing organization (CDMO), Hovione, has acquired ExtremoChem, which is a start-up company with a portfolio of rare sugars, expanding its technology platforms. According to a Nov. 16, 2023 press release, the acquisition gives Hovione access to ExtremoChem’s portfolio of rare sugars. These high-performance functional materials are synthetic analogues of the natural molecules found in extremophiles–organisms that can survive in uninhabitable environments—and have shown the potential to stabilize biopharmaceuticals during production, purification, formulation, and transportation. “Proteins and other biopharmaceuticals account for a significant share of our customers’ pipelines,” said Dr. Jean-Luc Herbeaux, CEO, Hovione, in the press release. “The acquisition of ExtremoChem’s synthetic sugars combined with Hovione's particle engineering capabilities provides our customers with a unique set of tools to optimize formulations that address stability issues encountered during the life cycle of biopharmaceuticals.” “I am delighted that ExtremoChem has been acquired by Hovione,” added Filipe Aguiar, managing director, ExtremoChem, in the press release. “Hovione has a long history of developing and industrializing innovative technologies for the pharma industry. This acquisition will help ensure that the science we developed at ExtremoChem will have a wider and faster market adoption.” This latest news from Hovione further bolsters the company’s position in seeking to expand its technology platforms, which it reports is needed to meet customer demand for integrated and differentiated development and manufacturing services. The acquisition of ExtremoChem adds to new partnerships forged by Hovione, such as that with H&T Presspart for the advancement of a dry powder inhaler platform and with Ripple to expand the use of the Epidel platform beyond ophthalmic applications.   Read the full article at    

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Hovione Expands Technology Platforms with ExtremoChem Acquisition

Nov 23, 2023

In the year 2021, when COP26 was held in Glasgow, Sterling Pharma Solutions came out announcing an ambitious target: to reduce the CDMO’s overall emissions by 50% by 2025 and by doing so, joining the international community’s fight against climate change. The CDMO Recipharm expanded its pressurized metered dose inhalers (pMDI) product development the following year to accommodate the switch to new propellants, which have 90% to 99.9% lower global warming potential than HFA134a. In the same year, WuXi STA won top scores from EcoVadis, a provider of business sustainability ratings, for their API and formulations factories located in China. Again, in January, Samsung Biologics was awarded the 2022 Sustainable Markets Initiative’s Terra Carta Seal in recognition of its commitment to achieving net zero greenhouse gas emissions across its direct operations and supply chain by 2050 or earlier. Similarly, Cytiva says its goal is to eliminate polystyrene from the company’s packaging materials and supply chain by 2025. These are just a few examples of a growing trend. A number of CDMOs are accelerating their environmental drive setting themselves far more ambitious targets than these as sustainability goals are now becoming one of the most urgent business strategies facing pharma companies. Presently, analysts say that there is a move away from sustainability being seen as something that is nice to have, to something more fundamentally important to businesses. "Sustainability commitments are no longer just desirable," says Jon Peers, director of sustainability at Hovione. "They are becoming mandatory, both directly by our regulatory authorities and indirectly by the regulatory and financial requirements faced by our customers." Hovione, a leader in spray drying and particle engineering, became a Certified B Corp in 2017 integrating an innovative community of companies that use the power of business to solve social and environmental problems. Pharma’s outsized impact Medicine making leaves an environmental impact which is quite massive. Estimates show that the pharmaceutical sector is accountable for as much as 4.4% of worldwide emissions—and if no action is taken—its carbon dioxide, a greenhouse gas (GHG), emissions are predicted to triple by 2050. Not only manufacturing but the distributing and transporting of medicines from the factory to the patient also carries a substantial environmental footprint. According to the Sustainable Markets Initiative’s (SMI) “Decarbonizing Healthcare Supply Chains” whitepaper, the biopharma industry is responsible for 4–5% of global GHG emissions, with most of its carbon footprint coming from supply chain, manufacturing, retail, and logistics. Having felt the heat, many leading pharma companies are already ahead of the curve on the path to net-zero carbon emissions. They have made carbon neutrality and net-zero pledges, some for as early as the next decade. Sustainability metrics: High on the agenda CDMOs demonstrate a strong determination to reduce their carbon emissions as environmental performance is being added to the list of demands by their clientele. Industry reports show that full waste recycling, green power percentage and green chemistries currently play a crucial role during negotiations between pharmaceutical companies and the CDMOs. These “sustainability metrics” are becoming increasingly important even as technology, track record, capacity, and cost are still the most important criteria for selecting CMOs/CDMOs. "Recognizing our commitment and progress made towards our sustainability targets, clients will seek out not only providers of CDMO services but also those companies with the competence to execute these services in harmony with the client’s respective sustainability goals," says Paul Zuechner, director, sustainability and reliability engineering, pharma services, Thermo Fisher Scientific. Thermo Fisher, which offers end-to-end solutions to small molecules as well as biologics, announced an acceleration of the target to reduce scope 1 and 2 GHG emissions to more than 50% by 2030. Zuechner maintains that the increasing focus on sustainability, resource and decarbonization quantifications is now elevating sustainability towards an equal project deliverable on par with cost, quality, and timelines. The sustainability initiatives by CDMOs are not only driven by customer preference but also by regulatory requirements, according to Peers of Hovione. Regulated and standardized reporting is there. The European Corporate Sustainability Reporting Directive (CSRD) together with the European Sustainability Reporting Standards (ESRS) is significantly raising the required levels of compliance. On top of this, businesses must meet their stakeholder’s requirements to provide material information that stands up to scrutiny. Headquartered in Loures-Portugal, Hovione believes that it is simply not possible to meet the challenging goals that have been set by the companies themselves on sustainability without further innovation, particularly through process intensification and the greening of pharmaceutical intermediate and API manufacturing. Safety via process efficiency Without question, manufacturers are aggressively pursuing various strategies to enhance processes as it becomes a business imperative for the service providers. "Olon tries to optimize plants' performances, in order to reduce the amount of energy, materials and natural resources they need,'' says Giorgio Bertolini, senior vice president of R&D, Olon Group, a global leader in the development and production of APIs, headquartered in Milan, Italy. Olon is working on cutting-edge R&D processes applied both to chemistry, in terms of flow chemistry, photochemistry, and electrochemistry, and to biotechnologies. Investing in and developing technological advances allows the organization to combine well-established practices with new ones, to guarantee efficient and successful manufacturing processes, at the same time ensuring safe, fast and cost-effective commercial processes. "We consider climate protection and the related reduction of GHG emissions to be a top priority," emphasizes Bertolini. To increase efficiency and reduce the energy required for production, especially in the functioning of reactors, Olon is implementing several continuous manufacturing processes, investigating both the flow chemistry approach and the continuous stirred tank reactors (CSTR) These approaches entail leaving no batch reactors with loading and unloading phases but keeping constantly active production units—either microreactors or small classical reactors. The outcome is that, at the same levels of production, continuous manufacturing processes can reduce the footprint of the manufacturing process in comparison with standard methods. This innovative production technique, he explains, enables a double positive impact in terms of sustainability. Indeed, it allows for the use of smaller amounts of material for the unit time, therefore resulting in increased local temperature control and in the possibility to avoid extreme temperatures, making the manufacturing process less energy intensive. It also provides greater safety for operators. The industry is now facing a change of paradigm, avers Bertolini, in which there is a continuous exchange of knowledge and information between the chemical and engineering sectors, which eventually results in the creation of new specific know-how and business synergies. Olon started constructing a new facility at its Rodano site (Milan, Italy) dedicated to ultra-potent compounds, used for antibody-drug conjugates (ADCs). Circular business models that combine a responsible use of natural resources and raw materials with a responsible waste management approach are what Olon strives to promote, according to Bertolini. Greening the supply chain To reduce effluents and design safer alternatives to hazardous processes organizations extensively explore the use of safer and more sustainable chemicals. This green chemistry approach can minimize the risk of impact on the environment to a great extent. Olon, for instance, is focusing on green chemistry projects for the replacement of chlorinated solvents and the reduction of critical substances which could be particularly toxic, especially in new manufacturing processes. Not only in manufacturing, quite a few companies are investing in greener biofuels (rather than diesel) for vehicles. As mentioned, distributing and transporting medicines from the factory to the patient also leaves a large carbon footprint. Temperature-sensitive products are loaded onto refrigerated vehicles to maintain cold-chain which require a considerable amount of energy to power. Environmental credentials are now integral to all supply chain decisions. There is almost a universal consensus on this approach, shows the CPHI sustainability sentiment index. In data released ahead of CPHI Frankfurt 2022, 95% of industry executives suggest it is either “important” or “extremely important” (52%) to have visibility on supply chain partners. Scope 3 emissions: Key challenge In comparison to the scope 3 tally that falls not within the organization's boundary, scopes 1 and 2 emissions are relatively minor. However, within these scopes, electrical energy consumption in manufacturing and the fugitive emissions from hydrofluorocarbons (HFC) released during pMDIs product lab testing are the highest. pMDIs and anesthetic gases can be particularly serious for global warming. The UK and several countries in the EU block including Belgium, and the Netherlands are now promoting dry powder inhalers in prescription guidelines. Meanwhile, the common general anesthetic desflurane is being replaced by lower-carbon alternatives in countries like Sweden. Scope 3 emissions, however, make up the majority of the pharma sector’s carbon footprint. Even though many CDMOs have set ambitious targets like striving for carbon neutrality across the entire value chain already by 2030, many are still simply focusing on scope 1 and 2 emissions. Observers say that this is largely because the need for sustainability in the pharmaceutical industry has become more apparent only in recent years. Another concern is the cost factor. According to Peers of Hovione, decarbonization costs in particular can be very expensive and require strategic planning and commitment from senior management to meet associated capital and operational costs. The sustainability challenge, he says, needs to be considered throughout the drug development life cycle, starting from simple assessments against sustainability principles and metrics early on and growing in detail and robustness as the drug progresses through the cycle. Shift in focus Experts, however, see a shift across the industry. Discussions about sustainability are taking place at the highest levels. An increasing number of pharmaceutical companies are prioritizing it when discussing projects with their CDMO partners. "Be it the fulfillment of new technical capabilities, increased production capacities, advancing regulatory compliance and now sustainability target introductions—it’s natural for us to solve for and achieve our customers’ product development, manufacturing, and corporate goals in partnership,” says Zuechner of Waltham, Massachusetts-headquartered Thermo Fisher. It will be essential for drug makers and their CDMO partners to work together on questions of sustainability, and to be ready with a sustainability agenda before starting to work on the project, in the coming years. It is important for CDMOs, says Peers, that their clients and suppliers share the same vision of a more sustainable industry as collaboration across the value chain is key to leveraging knowledge and driving change.   Read the article at  

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Net-Zero Pledge: CDMOs Go Greener

Jul 19, 2023

  The demand for inhalable drugs that require higher drug loads and the delivery of cohesive materials has increased Hovione and H&T Presspart have entered into a strategic partnership to advance the development of Presspart's Sunriser Capsule-based Dry Powder Inhaler platform.  The demand for inhalable drugs that require higher drug loads and the delivery of cohesive materials has increased, making it necessary to develop more efficient solutions. To meet this demand, the two companies will work together to develop the Sunriser Dry Powder Inhaler. This innovative and best-in-class capsule-based platform is flexible enough to address both the challenges of classic carrier-based and spray-dried engineered formulations. This partnership is an extension of a successful collaboration that has spanned several years on developing and commercialising innovative dry powder inhalation devices. As part of the joint development agreement, Hovione will exclusively partner with Presspart to exploit the Sunriser device in the field of engineered formulations for dry powder inhalation.  Presspart will remain responsible for the manufacturing of the Sunriser device. To provide further insights into the benefits of this partnership for the industry, a joint workshop will be held on May 3, at the Respiratory Drug Delivery (RDD) Europe 2023. "New inhalable therapies are often requiring delivery of higher doses of cohesive and sensitive powders. Our priority is to ensure maximum efficiency in delivering these drugs to the right locations in the lung,” said Dr Jean-Luc Herbeaux, Hovione’s CEO. He added: “We are thrilled to expand our current partnership with Presspart and combine our expertise in the fields of engineered particles and inhalers for the benefit of our customers and patients.”  Christian Kraetzig, President of H&T Presspart, commented: “Following our successful collaboration with Hovione on the PowdAir Plus DPI device development, we are once again extremely pleased to be working with Hovione in developing this next generation high performance DPI device. As the market leader in respiratory components and devices, this strategic partnership will allow H&T Presspart to expand its portfolio within the growing field of dry powder technology.” Pharmaceutical companies partnering with Hovione to develop their new inhalable drugs using the Sunriser device can leverage Hovione´s unparalleled expertise in inhalable APIs, formulation, filling, and analytical characterisation.  Additionally, with H&T Presspart's state-of-the-art device manufacturing and supply, from lab to commercial cGMP scale, companies can benefit from a comprehensive approach to drug development. This partnership enables pharmaceutical companies to access top-notch expertise and cutting-edge technology, ensuring the successful development and commercialisation of innovative inhalable drugs.    Read the article at  

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Hovione and Presspart extend technology partnership

May 03, 2023

  The move is set to expand the use of Ripple's Epidel platform beyond ophthalmic applications Hovione, specialist in spray drying and particle engineering, and Ripple Therapeutics, a leading ophthalmic sustained drug delivery company, have entered a strategic partnership to expand the use of Ripple's Epidel platform beyond ophthalmic applications.  The core feature of Ripple’s Epidel technology is the ability to deliver sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. This enables higher drug loading, smaller size implants, defined and predictable biocompatible degradation products with straightforward and scalable manufacturing processes. Surface erosion-based drug release provides a highly effective way to control dose and duration. By incorporating Ripple's Epidel platform into its toolbox, Hovione can expand its portfolio of novel drug delivery solutions to the pharmaceutical industry. “The combination of technology synergy, innovative vision and cultural fit makes collaborating with Hovione an exciting next step in the advancement of the Epidel platform beyond the ophthalmic field,” stated Dr Wendy Naimark, Ripple co-founder and Chief Technology Officer. “Hovione’s expertise in controlled, sustained drug delivery, along with their experience in chemical synthesis and pharmaceutical manufacturing, makes for a great partnership.” "We are thrilled to partner with Ripple, who developed a state-of-the-art platform for sustained release," said Dr Jean-Luc Herbeaux, Hovione's CEO. "Our shared goal is to accelerate and broaden the access to this highly innovative and enabling technology for the benefit of our pharmaceutical customers and their patients worldwide."    Read the article at  

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Hovione enters partnership with Ripple Therapeutics

Mar 21, 2023

Hovione, the leader in spray drying and particle engineering, won the 2023 CDMO Leadership Award across all six categories – capability, compatibility, expertise, quality, reliability and service across all three groups of respondents (Big Pharma, Small Pharma, and Overall (combined Big and Small Pharma)). Hovione was given additional recognition as a CDMO Leadership Award Champion in the categories of Compatibility and Expertise for scoring as a top performer in comparison to the weighted average of other CDMOs included in the Industry Standard Research (ISR)’s annual Contract Manufacturing Quality Benchmarking survey.  Established in 2011 by Outsourced Pharma and Life Science Leader, the CDMO Leadership Awards spotlight excellence in Capabilities, Expertise, Quality, Compatibility, Reliability and Service. The CDMO Leadership Awards teamed up with ISR to determine the award recipients – 72 contract manufacturers were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey.  “We are honored and proud to receive this award in all six categories. This broad recognition reflects the dedication of our team to help our customers deliver much-needed medicines to the market,” said Dr. Jean-Luc Herbeaux, Hovione’s CEO. “This is not the first time Hovione is recognized by the CDMO Leadership awards and winning these awards once again reinforces our commitment to excellence and differentiation in the services we provide to our customers.”  “For over a decade, these awards have been the most meaningful for biopharma organizations striving to obtain optimal outcomes from their outsourcing activities. Our research arm, ISR Reports, which only surveys drug sponsors who have worked directly and recently with specific CDMOs, ensures the validity of these results. Our winners are your gold medalists of outsourcing,” said Louis Garguilo, Chief Editor and Conference Chair of Outsourced Pharma. Hovione has been expanding worldwide, demonstrating the commitment to its customers. Hovione has been investing in new laboratory and production assets and innovative technologies to meet customer demand for integrated and differentiated services in manufacturing of drug substances, particles and drug products.    Read the entire article at     

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Hovione receives the 2023 CDMO Leadership Award in all six categories and is champion in Compatibility and Expertise

Mar 14, 2023

  The two companies, who had previously established a customer-supplier relationship, have created an agreement to advance the technology and to encourage adoption. Hovione and GEA will work together on continuous tableting technology, pairing the former's development and manufacturing expertise with the latter's engineering capabilities. In terms of their respective capacities, Hovione is a contract development and manufacturing organization (CDMO) providing services for drug substance and drug product. GEA is a supplier for systems and components for the pharmaceutical industry, as well as the food and beverage industry. The aim of the partnership is to accelerate the adoption of continuous tableting technology, and also to contribute to the establishment of new standards and market acceptance of the technology, the two companies stated. In looking to promote continuous processes, the companies outlined that such systems allow for leaner and risk-reduced development paths, streamlined supply chains, increased built-in quality, and that the manufacturing processes themselves have greater flexibility and reduced complexity. Both companies have been working in the continuous manufacturing space for a number of years. Nearly a decade ago, GEA began working with the US Food and Drug Administration (FDA) to validate continuous manufacturing, with the company stating at the time that the arrangement marked the "start of the end of batch manufacturing". For Hovione, the company stated that it has been actively working on developing continuous tableting solutions for the last seven years, and it recently invested in the technology within its own manufacturing network. In September 2022, Hovione announced that it had opened a new continuous manufacturing line at its Loures site, in Portugal. At the same time as the new line, the company established a multi-disciplinary global team specialized in continuous tableting. On its latest move in the continuous tableting space, Hovione's CEO, Jean-Luc Herbeaux, stated, "Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all... This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of continuous tableting equipment solutions and bring continuous tableting to the next levels of reliability, flexibility and adoption". In a recent interview with Outsourcing-Pharma, Bikash Chatterjee, CEO of Pharmatech Associates, stated that there is a growing momentum behind the switch to continuous manufacturing, even though this has been spoken of for a number of years. Chatterjee noted that one aspect that could accelerate this shift is the national policy in the US to increase the manufacturing of certain pharmaceuticals on home soil. As a result, more efficient manufacturing, such as continuous, will be required to make the process commercially viable.   Read the entire article at    

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Hovione and GEA aim to increase adoption of continuous tableting

Jan 04, 2023

Hints of new science emerge in a field of growth for pharmaceutical services firms.   Earlier this year, Hovione announced a partnership with a Danish firm that has developed a whey protein–based excipient meant to enhance spray-dry dispersions. Hovione saw in Zerion Pharma’s Dispersome a means of advancing its services addressing bioavailability in drug formulation. Zerion, launched in 2019, saw a clear advantage in teaming with a well-established pharmaceutical services firm recognized as a leader in spray-drying services. A few months later, Nanoform Finland, a nanoparticle engineering specialist based in Helsinki, announced a partnership with the specialty drug firm Pharmanovia, which will apply Nanoform’s nanoparticle technology and formulation know-how to improve the bioavailability of drugs in its product line. Zerion and Nanoform are among the growing number of firms trying to deal with problems related to drug bioavailability. Their approaches are welcomed by industry observers, given the increased urgency of such problems and the relative sparsity of technological innovation.   Bioavailability, a measure of the portion of an active drug substance that enters the body’s circulation and affects the drug’s target, may not be the steepest challenge faced by developers of new therapeutic compounds. But it may well be the most pervasive. By many estimates, 70–90% of new small-molecule oral drugs have problems related to solubility and absorption. These problems have been exacerbated in recent years by the increasing complexity of drug molecules, especially in the oncology arena, according to Peter Bigelow, president of xCell Strategic Consulting. The speed with which innovators need to move forward in development has also resulted in a growing market for particle engineering and design, he says.   “Because speed is kind of the most important objective of so many of these programs, changing the chemistry is not something they have the luxury to do,” Bigelow says. “A sponsor company will say, ‘I can’t take a year off to come up with a new synthetic route. So you’ve got to make this route to work.’ ” Bioavailability services first emerged among providers specializing in formulation rather than at contract development and manufacturing organizations (CDMOs), whose primary service centers on the manufacture of active pharmaceutical ingredients (APIs). But the field has shifted over the last decade with the broadening of service offerings among CDMOs and the emergence of a one-stop-shop approach.   BEYOND API MANUFACTURE One of the most popular techniques for improving bioavailability is spray drying, a method for converting poorly soluble APIs into an amorphous dispersion by dissolving the API and a polymer exipient in an organic solvent and evaporating the solvent with heated gases. Hovione was an early adopter, investing in its first spray-drying capacity in 2004, but not with an eye toward improving bioavailability of customers’ drug candidates. “This is a good example of taking the right decision for the wrong reason,” says Guy Villax, who stepped down as CEO of the family-owned company earlier this year but remains on its board. “I was out in the market looking for business. I came across two inquiries that needed spray drying. We decided if customers were ready to make commitments, we were willing to invest.”   "To be successful you need more than the hardware." - Filipe Gaspar, chief technology officer   The contracts involved work on Captisol, a solubilizing agent whose manufacture required spray drying as an isolation technique. “There was nothing strategic in terms of addressing poorly soluble molecules,” Villax recalls. But as a result of those early contracts, Hovione was in position to provide solubility services—notably for hepatitis C drugs—as the market grew. Hovione significantly increased its spray-drying capacity in 2009, when it acquired a Pfizer plant in Cork, Ireland, that included what at the time was the world’s largest solvent-based pharmaceutical spray-drying tower. Other CDMOs have added services more recently. Fabbrica Italiana Sintetici (FIS) adopted spray drying in 2017, when it opened a new facility at its headquarters plant in Montecchio, Italy. FIS also provides micronization, a process of physically and mechanically breaking up drug crystals, and lyophilization, a freeze-drying means of manipulating particle size. Its sister company, Brenta, is a nanotechnology specialist offering formulation services that address API absorption and bioavailability. “FIS is a drug substance manufacturer; we are not in drug product,” says Luca Parlanti, the firm’s marketing director, using industry terms for active chemicals and finished drugs. “However, we recognized the increasing relevance of particle-size solid-state technology in general. It is important for a provider like ourselves to offer a forward integration into areas that bridge drug substance and formulation.” Particle engineering is a method of addressing not only bioavailability but also processability, Parlanti says, “because solid-state properties may impact the flow of a drug in the formulation process.”   BROAD PORTFOLIOS Lonza, one of the largest contract API manufacturers, has extended services into particle design via acquisition. The company acquired Capsugel, a formulation services specialist, in 2016, 3 years after Capsugel bought Bend Research, a leader in spray-dry dispersion services. The Capsugel deal also netted Lonza micronization services, but the Swiss firm recently divested assets, notably a plant in Quakertown, Pennsylvania, that was acquired by investors and set up on its own as Microsize. Lonza announced last month that it would introduce X-ray powder diffraction technology, an analytical tool to improve jet-milling micronization, at its formulation services operation in Monteggio, Switzerland. The company’s sale of the Pennsylvania plant is the latest transaction for a business dating back to 1994, when it began as Powdersize. It changed hands twice—purchased first in 2013 by Microsize’s current CEO, TJ Higley, and then by Capsugel. Higley left after the Lonza acquisition and returned to head the company this year. Higley says Microsize maintains its heritage of micronization, which he characterizes as a first line of attack in addressing bioavailability. He says the advantages of micronization include ease of process development and scale-up, an increase in particle surface area, processing at ambient temperatures, and overall low cost compared with its primary alternative, spray drying. Higley sees Microsize in a strong position. “The market is capacity constrained,” he says. “There is plenty of work out there, plenty of demand.” Some drugmakers have responded by setting up in-house particle design centers, “but there are huge limitations because people aren’t experts at it.” Nor are the in-house facilities typically capable of processing APIs from gram scale up to clinical and commercial scale, he says. “I would say people are bringing early, small-scale micronization in-house,” Higley says. “So, at some point they are going to need to outsource.” Catalent, another big services firm that has amassed particle design services, has bioavailability assets that date back nearly a century. “Catalent has been in the business of increasing oral bioavailability for oral delivery of active ingredients since the RP Scherer business was formed in 1933,” says Cornell Stamoran, vice president of corporate strategy, referring to a company formed by Robert Pauli Scherer, inventor of the rotary die encapsulation process used to formulate soft gelatin capsules. “I have a lab notebook in my office of one of the first R&D people on their second or third project, which was increasing bioavailability of fish oil.” Scherer was purchased in 1998 by Cardinal Health, which spun out its pharmaceutical services business as Catalent in 2007. Catalent has since acquired Pharmatek Laboratories, a drug services firm with spray-drying capabilities, and Juniper Pharmaceuticals, an expert in spray drying, nanomilling, and hot-melt extrusion—a method of melting a substance and forcing it through a die to form a new structure; it is widely employed in plastics and has more recently been adapted to pharmaceutical particle design applications. Thermo Fisher Scientific, a pharmaceutical services firm that took a leadership position in formulation services with the acquisition of Patheon in 2017, has also built a portfolio of bioavailability technologies. It added small-scale spray-drying dispersions with the purchase of Agere Pharmaceuticals in Bend, Oregon, which was formed in 2016 by the former CEO of Bend Research. Thermo Fisher added commercial-scale spray drying at a plant in Florence, South Carolina, shortly after acquiring the site from Roche in 2016. The Roche site also added micronization to Thermo Fisher’s tool kit. And the company invested in small-scale hot-melt extrusion capacity in Bend before scaling up the technology at its plant in Cincinnati. Both Catalent and Thermo Fisher have introduced systems to assess the most effective approach to formulation in early-stage drug development, including the selection of techniques to address bioavailability. Catalent has a program, OptiForm, that is based on a predictive modeling regimen it acquired from GSK in 2010. And Thermo Fisher introduced a predictive modeling tool, called Quadrant 2, that guides drug developers in choosing particle design approaches.   NEW WAVE Meanwhile, there are indications that improved approaches are coming to the market. Based on research that began at the University of Copenhagen, Zerion has developed a technology that uses proteins to increase small-molecule drug solubility and that constitutes an alternative to known polymer excipients in spray-dry dispersion applications. “We researched all sorts of different materials, including mesoporous silica, amino acid peptides, and cellulose nanofibers and eventually also proteins,” says Korbinian Löbmann, who is now Zerion’s chief science officer. The firm zeroed in on proteins. “We tested all the different proteins we could get our hands on, and out of all that research we identified that whey proteins worked particularly well not only for amorphous stabilization but also solubility enhancement,” Löbmann says. The whey protein also allowed significantly higher drug loading—up to 70% of the weight of the particle as opposed to an industry standard of 30% at the high end. Researchers filed a patent on behalf of the university and formed Zerion. The company has a partnership with Arla Food Ingredients, a specialist in whey protein processing that has developed a means of purifying β-lactoglobulin from whey protein isolate, for which the largest market is infant formula. Interest in the protein excipient Dispersome has materialized, says Zerion CEO Ole Wiborg, and the firm now has contracts with four major drug companies. And then there is the partnership with Hovione. “We were approached by Hovione, and this was very positive,” Wiborg says. We could see there was a lot of synergy between what we offer and what Hovione offers. And Hovione is, if not the best, then one of the best at spray-dry amorphous dispersion.” Moreover, Wiborg says, Hovione opens the door to small and midsize companies, the primary pharmaceutical innovators, which have been more difficult to identify and connect with than the majors. Hovione also sees benefits for both partners, whereby it gets access to a sophisticated new technology and boosts market access for a start-up, says António Dinis, Hovione’s director of sales and marketing. The deal establishes Hovione as “the sole partner for promoting the technology into the pharma marketplace,” he says. The arrangement is the first in which Hovione has gained new technology through a partnership, he adds. It may not be the last, given the industry’s problems with bioavailability. “Hovione is actively pursuing opportunities to enhance our technology offering to address these problems,” Dinis says. “Hovione will from now on be much more open to partnering with companies that help us bring more solutions to our customers.” Nanoform, which spun out of the University of Helsinki in 2015, has innovated a nanocrystalization approach to particle design by employing supercritical carbon dioxide. The company’s controlled expansion of supercritical solution technology produces particles as small ​as 10 nm but more typically within a range of 100–300 nm without the use of solvents, excipients, or polymers. The technology works by dissolving APIs in supercritical CO2 and controlling the pressure through a flow process to achieve supersaturation, which leads to crystallization or precipitation, according to Christopher Worrall, Nanoform’s vice president of US business development. The reduced size increases particles’ surface area, thereby increasing the dissolution rate and thus bioavailability. Nanoform signed its first contract last year for a drug produced according to the Finnish Medicines Agency Fimea's good manufacturing practice standards and has a goal of signing three such contracts this year.   TWEAKS AND TRANSFORMATION Despite the paucity of wholly new approaches to particle design, efforts are underway to improve workhorse approaches such as spray drying. Deanna Mudie, a principal scientist at Lonza’s operation in Bend, says Lonza has been experimenting with methods to facilitate amorphous dispersion of so-called brick-dust APIs—poorly soluble drugs with high melting points. “When drugs have poor solubility in organic spray-dry solvents, you end up with a very low throughput and also high organic solvent usage, which of course is not environmentally friendly,” Mudie says. One approach is to install a heat exchanger before the spray-drying step to increase a drug’s solubility in an organic solvent. The company is also applying environmentally friendly solvents, such as acetic acid, to processes to reduce the use of standards such as acetone, methanol, and in some cases environmentally impactful solvents such as dichloromethane. “In general, we have had that focus on improving spray drying over the last 5 years,” Mudie says. “There is a big push because we have seen a trend toward the brick-dust APIs.” While CDMOs have tended to bring on board tried-and-true methodologies for addressing bioavailability, adding such services can have a transformative impact. At Hovione, research in particle design has grown from a small research group of five chemists in 2005 to a multidisciplinary division with 70 scientists, including chemists, chemical engineers, biologists, and mathematicians.   “To be successful you need more than the hardware,” says Filipe Gaspar, Hovione’s chief technology officer and head of its particle design group. “You need the software, the people, the knowledge in R&D, the marketing effort. It is the coordination of a lot of disciplines.”   And innovation in particle design, as well as the customer engagements that arise as a result, aims CDMOs toward broader activity in services downstream from API manufacturing. Last month, Hovione announced the start of a new continuous tableting operation at its site in Loures, Portugal. Dinis sees a continuity in the growth of services. “A hundred percent of the powder we process in tableting comes out of spray drying,” he says. “If we weren’t working in spray drying, we would not be involved in tableting.”   Read the entire article at    

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Making drugs more bioavailable

Sep 25, 2022

Portuguese pharmaceutical company Hovione has announced a “state-of-the-art, continuous manufacturing facility” is set to come online at its Loures site in Portugal. The company has also established a multi-disciplinary global team in continuous tableting, while upgrading its labs with the tools needed to support the drug product lifecycle. Jean-Luc Herbeaux, Hovione’s CEO, said: “Hovione has been historically focused on innovative technologies that benefit our customers and patients. With this investment in continuous tableting, our customers can rely on our support to bring much needed medicines to the market as fast as possible with the highest quality and manufacturing standards.” Herbeaux added: “We are investing to accelerate the adoption of this technology as we continue to innovate and enhance our offering around our areas of expertise.” "This investment in continuous tableting from R&D to production further strengthens Hovione´s CDMO offering" The technology offers advantages including faster development of simpler processes, manufacturing for variable demand, control strategies and high process quality standards. Filipe Neves, Hovione´s Strategic Business Director, said: “This investment in continuous tableting from R&D to production further strengthens Hovione´s CDMO offering and responds to the growing customer interest.” Continuous manufacturing is expected to change the landscape of drug product development and commercial production. The Food and Drug Administration (FDA) is partnering with the International Council for Harmonisation and leading a global initiative to advance continuous manufacturing of small molecules and other pharmaceutical modalities.   Read the full article at     Learn more about Continuous Tableting at Hovione  

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Hovione expands manufacturing with continuous manufacturing facility

Sep 07, 2022

The Mark is operated by Business in the Community Ireland (BITCI), the non-profit organisation dedicated to sustainability and third-party audited by the National Standards Authority of Ireland (NSAI). Seven companies achieved the Mark for the first time with another ten achieving recertification.       Press Release Thursday 17th February:  Over 200 business leaders attended Business in the Community Ireland’s virtual celebration event where the latest companies certified to the Business Working Responsibly mark in 2021/2022 were announced. The Mark which is run by Business in the Community Ireland and based on ISO 26000 is valid for three years and is independently audited by the National Standards Authority of Ireland (NSAI). Seven companies are being accredited to the Mark for the first time this year and they are Alkermes, An Post, Grant Thornton Ireland, Iarnród Éireann – Irish Rail, Ornua, Vermilion and William Fry. In addition, ten companies achieved recertification to the Mark and they are Boots (Retail) Ireland Ltd, BT Ireland, Central Bank of Ireland, CRH Operating Companies in Ireland, Deloitte Ireland, Gas Networks Ireland, HEINEKEN Ireland, Hovione, Intel Ireland and Sodexo Ireland. 46 companies in Ireland have now achieved the sustainability standard. The Mark  looks at leadership, policies, practices, performance and impact in areas such as employee wellbeing, diversity and inclusion, environmental practices, supply chain management and engagement with the local community. For more details on our sustainability standard, visit the Business Working Responsibly mark section of our website.    Read the full article on    

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Seven Companies in Ireland achieve the Business Working Responsibly mark with a further ten recertifying to the standard

Feb 17, 2022

The Portuguese drug services firm Hovione has outlined a $170 million investment program through 2023 that it says will increase its production capacity by about 25%. In East Windsor, New Jersey, where Hovione is investing $50 million, the company will add two spray dryers, tripling capacity, and expand its capacity to make research- and small-scale quantities of active pharmaceutical ingredients (APIs). “We are looking to build this up to a significant site for Hovione with more than 300 people,” says Jean-Luc Herbeaux, the firm’s chief operating officer. Hovione currently employs about 150 people in New Jersey. In Cork, Ireland, it will spend about $50 million to upgrade its high-potency API production and add a spray dryer. In Loures, Portugal, Hovione is spending $70 million on additions such as a new manufacturing building and an eight-lab quality control facility. These projects, some of which are already complete, will take up all the available space at the Loures site, according to CEO Guy Villax. “Last year we broke $300 million in sales,” Villax says, and the firm is targeting $400 million this year. “The company needs to be less Portuguese. You will see us invest and grow our footprint more in the US than elsewhere.”The Portuguese drug services firm Hovione has outlined a $170 million investment program through 2023 that it says will increase its production capacity by about 25%. In East Windsor, New Jersey, where Hovione is investing $50 million, the company will add two spray dryers, tripling capacity, and expand its capacity to make research- and small-scale quantities of active pharmaceutical ingredients (APIs). “We are looking to build this up to a significant site for Hovione with more than 300 people,” says Jean-Luc Herbeaux, the firm’s chief operating officer. Hovione currently employs about 150 people in New Jersey. In Cork, Ireland, it will spend about $50 million to upgrade its high-potency API production and add a spray dryer. In Loures, Portugal, Hovione is spending $70 million on additions such as a new manufacturing building and an eight-lab quality control facility. These projects, some of which are already complete, will take up all the available space at the Loures site, according to CEO Guy Villax. “Last year we broke $300 million in sales,” Villax says, and the firm is targeting $400 million this year. “The company needs to be less Portuguese. You will see us invest and grow our footprint more in the US than elsewhere.”   Read the entire article on  

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Hovione will expand 3 pharmaceutical chemistry facilities

Jan 24, 2022

Solid growth and sizable investments will continue in the pharmaceutical services sector as contract manufacturers of active pharmaceutical ingredients (APIs) and drug intermediates move into a third year of navigating the unpredictable impact of the pandemic. “Aside from what you can’t predict, it’s a very good time to be in contract services,” says Wayne Weiner, who heads the consulting firm PharmaTech Solutions. “It doesn’t seem the funding will dry up for biotechs, which are really driving a lot of the innovation.” And biotech innovators without production assets are increasingly bringing drug candidates to market themselves rather than licensing to larger drug companies, thus generating longer-term contracts with service firms, Weiner says. But James Bruno, president of another consulting firm, Chemical and Pharmaceutical Solutions, sees a red flag. “I think we are going to be short on capacity all year,” he says. “Everybody seems to be booked.”   Managers at service firms agree that capacity constraint is a concern, and they point to continued investment in new capacity in response. Hovione, CordenPharma, and Pharmteco are among the companies with plans to add small-molecule API capacity. Hovione is expanding on both sides of the Atlantic; the Portuguese firm is 2 years into a 3-year program that is expected to increase overall capacity by 25%. CordenPharma will expand clinical-scale peptide production in Frankfurt, Germany, and solid-dose drug output in Plankstadt, Germany. Pharmteco is expanding API production in South Korea and is adding capacity at a newly acquired cell and gene therapy site in France.   While service providers are likely to continue broadening their offerings beyond small-molecule API production in 2022, services for the emerging cell and gene therapy industry will develop on a parallel track and attract only a handful of the largest traditional firms. Cell and gene therapy is getting a lot of attention, Bruno says, but most of the investment in the drug services sector will continue to be in small-molecule production.   Read the article at  

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Pharmaceutical services to grow for another year

Jan 17, 2022

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