Press Room

Loures, Portugal, May 4, 2020 – Hovione announced today the appointment of Dr. Jean-Luc Herbeaux as Chief Operating Officer (COO), effective May 1st, 2020. Dr. Herbeaux held, over the past 20 years, multiple high-level leadership positions at Evonik, bringing to Hovione a proven commitment to develop a successful and globally active business. Based in Lisbon, Portugal, Dr. Herbeaux will work directly with Mr. Guy Villax, Hovione’s Chief Executive Officer, in executing the company’s strategy and vision. “We are delighted to welcome Dr. Herbeaux to Hovione. Jean-Luc will oversee all aspects of Hovione’s business operations and I see the creation of this position as another major steppingstone in our journey to become an even stronger company. Our new structure will develop synergies and increase operational efficiency, which will benefit the customers. I am sure this appointment will bring great things to all stakeholders – patients, customers, and team members as well as shareholders. Our leadership team is now well positioned to accelerate our long-term growth plans”, said Mr. Guy Villax. “I am really excited to take on the COO role at Hovione. Hovione is a company with a great vision, great people and great science and it has an important role in the pharma industry. I look forward to working with Guy and the Hovione Team to bring this already successful company to new heights”, said Dr. Jean-Luc Herbeaux. Prior to joining Hovione, Dr. Herbeaux headed the Health Care Business Line of Evonik, where he repositioned the business by driving an intentional, sustainable, and profitable growth agenda. His earlier postings, which included senior positions in Europe and Asia, allowed him to develop strong experience in management of complex global organizations.     About Hovione Hovione is an international company with 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the US, Macau, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and cGMP-compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.

Press Release

Hovione Announces the Appointment of Jean-Luc Herbeaux as Chief Operating Officer

May 04, 2020

  Hovione Technology recently announced its innovative 8Shot Dry Powder Inhaler (DPI) enabling high-dose drug delivery to the lungs has received the Red Dot 2020 Product Design Award in the Healthcare Daily Living AIDS category. The Red Dot Design Award is an internationally recognized quality seal awarded for innovative and high-quality product design. “The Red Dot jury’s experience and expertise evaluating outstanding product design and technical innovation for more than 60 years is unparalleled. This distinction awarded to our 8Shot DPI is a great success for Hovione Technology”, said Peter Villax, Hovione Technology’s CEO. 8Shot is the world’s first 8-puff, disposable DPI enabling drug delivery of new pharmaceutical compounds requiring very high doses delivered to the lungs. It delivers therapeutic doses up to 400 mg formulated as drug alone or engineered particles in multiple, sequential inhalation maneuvers for maximum therapeutic benefit and patient safety. “We are extremely proud and delighted to accept the Red Dot  Product Design Award, together with our design and development partner WeADD,” said Dr João Ventura Fernandes, Hovione Technology’s Director of Technology Development and Licensing. “The 8Shot™ DPI is uniquely positioned to make available off-the-shelf to pharmaceutical companies a patented high payload DPI to deliver inhaled biologics, antibiotics, anti-virals, vaccines, pain or rescue treatments requiring high-dose drug delivery.” Hovione Technology’s TwinMax and 8Shot dry powder inhalers are designed to enable safe and effective delivery of large doses to the lung. Featuring patented inhaler technology, TwinMax and 8Shot are compatible with drug doses up to 100 mg and 400 mg respectively, delivered conveniently to patients from multiple inhalations. Our Large Dose DPIs are suitable for inhaled delivery of biologics, antibiotics, anti-viral, vaccines, pain or rescue treatments.  Hovione Technology offers access to a complete portfolio of innovative, cost-effective dry powder inhalation devices – disposable, capsule-based, blister-based and large dose DPIs. With over 20 years of expertise developing innovative inhaler technology, Hovione Technology’s team has been behind the first market approved disposable dry powder inhaler for influenza treatment in Japan, the TwinCaps DPI. Millions of patients are being treated every year with Hovione Technology’s innovative inhaler technology. For more information, visit WeADD is a Portuguese Company specialized in innovation, development, product engineering and intelligent property in small and large appliances, machinery, functional packaging and consumer electronics in sectors such as health, sports, coffee and internet of things. For more information, visit   Read the article at DDD    

Press Clipping

Hovione’s Inhaler for High-Dose Delivery Earns Product Design Award

Apr 16, 2020

Based on research from Industry Standard Research's Contract Manufacturing Quality Benchmarking annual online surveys, more than 125 contract manufacturers were evaluated on 23 different performance metrics. Research participants were recruited from biopharmaceutical companies of all sizes and were screened for decision-making influence and authority when it comes to working with contract manufacturing suppliers. Respondents only evaluated companies with which they have worked on an outsourced project in the past 18 months. This level of qualification ensures that quality ratings come from actual involvement with a business and that companies identified as leaders are backed by experiential data. CMOs have an opportunity to win these awards in up to three groups of outsourcing respondents - Big Pharma, Small Pharma, and Overall (combined Big and Small Pharma). According to Life Science Leader magazine, in the 2020 CMO Leadership Awards, Hovione wins the following categories: Champion in the Expertise category  Exceeds customers expectations in the Capabilities Compatibility Quality Reliability and, Service categories Outside of the core metrics of capabilities, compatibility, development, expertise, quality, and reliability, the Individual Attribute Awards identify common themes sponsor companies consider when choosing a supplier. And Hovione was recognized in  Accessible Senior Management Innovation On-Time Reputation Right First Time State-of-the-Art Strength of Science           See the Award's Issue        


2020 CMO Leadership Award

Apr 10, 2020

Chemical companies continue to invest in hand sanitiser in response to the Covid-19 pandemic. A large number of them are now producing in significant volumes. Ineos, the largest European producer of the two key raw materials - isopropyl alcohol (IPA) and ethanol – has announced its intention to produce 1 million bottles of hand sanitiser/month from each of three newly built facilities in the UK, Germany and France. As of the end of March, the company has hit its target of building the first plant near Middlesbrough, UK. It will supply hospitals free of charge “during the crisis period” and is in discussions with retailers. Dow announced on 30 March that its sites at Auburn, Michigan; South Charleston, West Virginia; Seneffe, Belgium; and Hortolândia, Brazil “possess the necessary raw material handling, mixing and packaging capabilities and will produce hand sanitiser”. They join the site at Stade, Germany, which is already manufacturing it. Dow, like Ineos, was already producing raw materials, said that it could adapt its capabilities for downstream production with “little to no impact to normal operations”. Auburn can produce 7 tonnes/week and similar volumes are expected at the other sites. Once all are at full production, the company expects to produce 200 tonnes. All of the hand sanitiser that will be produced has been allocated, with the majority for donation to state and regional health systems and government agencies for distribution. It will also be distributed to Dow production sites to help protect frontline employees. The first deliveries are expected to begin in the first week of April. Plant-based ingredients firm Roquette has adapted one of its pilot lines at its site in Lestrem, France, to manufacture about 5,000 litres/week of a hydro-alcoholic disinfectant solution. The first shipments were sent to Lille University Hospital Centre, the French Blood Donors Organisation and to other local health facilities, in coordination with the Hauts-de-France Regional Health Agency and the local authorities. In Germany, Wacker donated 15,000 litres of hand sanitiser for the production of disinfectants to Bavarian hospitals and care facilities at the request of the state Ministry of Economic Affairs. The alcohol needed, 11,000 liters of 2-propanol, was transported from Nünchritz, Saxony, to the Gendorf chemical industry park in Bavaria to be mixed and sent to an official distribution centre. Swiss pharmaceutical CMDO Siegfried is also supplying disinfectant in those regions where it operates production sites, including the Swiss cantons of Aargau and Valais and around Minden in Germany. “The service including delivery is free of charge to the extent possible,” the company said, adding that it will not supply private or commercial organisations. Meanwhile, Croda International said that it has gifted enough glycerine to regular customers to manufacture five million 250 ml bottles of hand sanitiser, assuming 2% glycerine content. It is also donating saponin vaccine adjuvants to projects working on a vaccine. The company plans to review with customers where more glycerine could be gifted. Similarly in the US, Amyris, which is in discussions for the testing of its fermentation-derived squalene as a vaccine adjuvant for a Covid-19 vaccine, has launched its own No Compromise Pipette Baby branded hand sanitiser. The company said that it “will not price its hand sanitiser at a premium, and plans to donate part of the supply to front-line health staffers and medical personnel”. It plans to produce 30,000 units in the first few weeks. Portugal’s Hovione began producing IPA- and ethanol-based hand sanitiser to a WHO formulation at tonne-scale for itself when supplies were short, it has emerged. The company, another major pharmaceutical CDMO, is now supplying the material free to Portuguese hospitals. Volumes were expected to reach 30 tonnes by the end of the month. Earlier in March, Lanxess added a second shift at its site in Sudbury, UK, to boost production of Vikron sanitiser. Earlier, BASF announced plans to produce hand sanitisers at Ludwigshafen and supply them to hospitals in the Rhine-Neckar metropolitan region. The company has now reallocated tonnes of raw materials, especially IPA, for making the sanitisers and secured legal official permission to make them. Similarly, Huntsman and Syngenta began making hydro alcoholic solution to produce hand sanitiser at Monthey, Switzerland, for free-of-charge supply to hospitals and pharmacies in the Canton of Vaud and the General Hospital in Lausanne. Plans were to ramp up production to 3-5 tonnes/week. Arkema has repurpose da production line at its Rhône-Alpes Research Centre in order to make 20 tonnes/week of alcohol-based solution to be distributed free of charge for the mass restocking of public hospitals. The effort is not limited to chemical companies, of course. Flavours and fragrance giant Firmenich has shifted production at La Plaine, Switzerland, to disinfectant solution, while luxury goods maker LVMH and many manufacturers and distillers of spirits on both sides of the Atlantic have also switched production.   Read the article at Specchemonline    

Press Clipping

Covid-19: Hand sanitiser effort continues

Mar 31, 2020

About 6 weeks ago, the pharmaceutical chemical maker Hovione ran out of disinfectant gel at its plant in Macau. “So the guys just used their heads and started manufacturing it themselves,” CEO Guy Villax says. Hovione is one of a number of chemical, distilling, and other companies that are starting or increasing production of hand sanitizers and sanitizer ingredients needed during the coronavirus pandemic. Some are already in the sanitizer business. Others, like Hovione, jumped in during a time of need. Impressed by the initiative in Macau, Villax put staff at the company’s plant in Loures, Portugal, to work making alcohol-based sanitizer at metric-ton scale. Hovione is distributing it to hospitals, other health-care facilities, and municipalities in solution and gel formulations. Hovione has enlisted a dedicated production line in Loures staffed by a team of about 30 workers. The company is using a formula available from the World Health Organization involving mainly ethanol or isopropyl alcohol and glycerin. Production volume was expected to reach 5 metric tons (t) during the week of March 16 and as much as 30 t by the following week. “At the moment we have hospitals asking us for 6 to 10 t, small entities asking for 100 L,” says Filipe Neves, pilot plant operations director, who is overseeing the project for Hovione in Loures. In Germany, the big chemical maker BASF says it is preparing to manufacture hand sanitizer at its headquarters complex in Ludwigshafen, where it makes raw materials for sanitizers. The company plans to distribute the product to area hospitals. UK-based Psychopomp & Circumstance Distillery, which normally distills gins and rums, is using its still to make sanitizing hand gel that it is giving away. Consumers can top up their own refillable bottles at the firm’s still in Bristol and leave a donation for a local children’s hospital. At the moment we have hospitals asking us for 6 to 10 t small entities asking 100 L. Filipe Neves, pilot plant operations director, Hovione The company started out mixing its alcohol with aloe vera gel but has since switched to glycerin. “We are making as much of it as we can without going bankrupt,” Psychopomp cofounder Liam Hirt says. Ireland-based Listoke Distillery has also switched production from gins to alcohol for hand gels, as have Taiwan Tobacco and Liquor and a number of small US distillers. The flavor and fragrance producer Firmenich has shifted production at its La Plaine, Switzerland, facility to disinfectant solution. LVMH, the parent company of luxury goods maker Luis Vuitton, has switched three of its perfume facilities in France to making “substantial quantities” of alcohol-based hand sanitizer. The firm is giving the product to the French health authorities for free. Specialty chemical manufacturers in the business of making sanitizing and disinfecting chemicals are boosting production. Lanxess is significantly increasing output of its Vikron sanitizer in Sudbury, England—introducing a second shift. The company recently donated a metric ton of disinfectant to hospitals in Wuhan, China, the epicenter of the virus outbreak, and to nearby cities. And Gelest has significantly ramped up production of its Biosafe antimicrobial agent at its facility in Morrisville, Pennsylvania. Based on a silane quaternary ammonium salts, Biosafe punctures the cell membranes of microbes, destroying them on contact. Applications include formulations used by food service workers. Biosafe is also the microbe-killing ingredient in a laundry additive called Certainty Smartboost, from the uniform company Careismatic Brands, which is sold primarily to health-care workers in specialty stores near hospitals. Workers use the treatment on their hospital scrubs or uniforms because it provides antimicrobial protection after they are washed. Drums of Biosafe are “flying off the shelves” to formulators of cleaning products, including nonwoven wipes, according to Gelest CEO Ken Gayer. “We’re now also seeing direct orders from hospitals that want cases and cases of this material and are giving it to staff members.” Read the article at C&EN website    

Press Clipping

Stepping up to the hand sanitizer shortage

Mar 19, 2020

Firms signal preparedness, but warn that prolonged plant closures and travel restrictions may cause significant disruptions Major drug companies have issued statements in recent days assuring the public that their inventories are adequate in the face of supply chain threats stemming from China’s coronavirus outbreak. Suppliers of active pharmaceutical ingredients (APIs) are also assuring customers that they are prepared for temporary interruption in the supply of key ingredients from Chinese firms. However, API makers in Europe and the US warn that supply disruptions could result from a protracted delay in restarting production at plants closed in recent weeks by the Chinese government or prolonged transportation restrictions. James Bruno, president of the consulting firm Chemical and Pharmaceutical Solutions, notes that travel restrictions are already interrupting business with Chinese suppliers. “First of all, nobody is going to be able to get to China,” he says, “so all the audits are going to be canceled.” Bruno adds that the travel restrictions will prolong plant closures stemming from Chinese New Year celebrations, which began on Jan. 25 and are scheduled to run to Feb. 8. “These guys have gone home and may not be able to get back to where they were working,” he says. The initial quarantine of Wuhan, the city first impacted by the virus, has broadened to include travel bans in other major cities, Bruno notes. “It’s not just Wuhan. It’s China.” Bruno says he has received calls from clients asking where they might find alternative sources of materials purchased from China. “The good news is that most of the people dealing with China tend to have inventory,” he says. “But if this doesn’t straighten out in the next 3 months, we could have some real problems with supply disruption.”   Guy Villax, CEO of the pharmaceutical chemical maker Hovione, says 50 people did not show up for work on Feb. 4 at the company’s plant in Macao, which employs 200. “Twenty-five of them live across the border in China, and China’s instructions are to stay at home,” he says. “But the issue is not whether the plant is producing; the real question is whether there will be transport to move goods around. Right now the head of the plant doesn’t know if he’ll get supplies from China.”   Asymchem, a pharmaceutical chemical manufacturer in Tianjin, China, approximately 1,160 km from Wuhan, also notified customers of contingencies related to the virus outbreak. The company told customers on Jan. 30 that it had pre-stocked materials to support production for at least a month and that it has not experienced delays on projects. Asymchem reports that 45 employees, about 1% of its workforce, were quarantined by authorities after traveling during the holiday. The firm says it expects its plants to open on Feb. 10. “We will closely monitor the situation as it evolves, and take action proactively for assurance of supply,” Asymchem Senior Vice President Elut Hsu says in the letter. Sources agree that the full impact of prolonged restrictions in China is difficult to gauge. According to a recent report by the US Food and Drug Administration, China is home to approximately 13% of the 1,788 facilities that manufacture APIs for drugs marketed in the US. Given the reassuring reports from drug companies and API producers, there is no reason to fear a significant disruption in the pharmaceutical supply chain, says industry consultant Steven Lynn, a former head of the FDA’s quality compliance office. “Fearmongering is not something we should be doing,” he says. But API suppliers should take advantage of a short-term disruption to review supply chain and logistics vulnerabilities. “Churchill had a good quote,” Lynn says. “‘Never let a good crisis go to waste.’”.   Read the article  

Press Clipping

Coronavirus puts drug chemical industry on alert

Feb 04, 2020

Biologics raise unique formulation and development challenges, and industry is still on a learning curve to get the best out of these diverse and complex therapies. The global biologics market has experienced significant growth over recent years and, according to market research, is expected to continue to grow in the near future, potentially being worth $625.6 million by 2026 (1). Advancement of the sector is projected to be driven by an increase in prevalence of chronic conditions, technological advancements, mergers and acquisitions, more market approvals, and the development of more efficient biologics (1). However, biologics raise unique challenges in formulation and development, not least as a result of the large size of the molecules but also due to other characteristics of the complex API. According to Fran DeGrazio, vice-president, Global Scientific Affairs and Technical Services, West Pharmaceutical Services, the size of biologic drug products is particularly challenging when approaching drug delivery. “To be most effective, biologics must typically be injected directly into the bloodstream,” she says. “Additionally, biologics are sensitive to their environment and can easily aggregate or denature, leading to problems such as the formation of particles, which may then be injected into the patient.” “Biological molecules are not only larger in size but also more complex in structure when compared with small molecules,” concurs Constança Cacela, director—RD Analytical Development, Hovione. “This structural complexity can lead to challenges in ensuring stability during processing and long-term, which may result in potential losses of activity and increased immunogenicity.” Circumventing phenomena, such as denaturation, aggregation, and other forms of structural change, are of key importance when processing and developing formulations with biological molecules, Cacela further explains. “These aspects of biologics are responsible for an increased difficulty, requiring advanced technical expertise,” she says. Administration: Moving from IV to SC? When developing large molecule formulations, and depending on the delivery route, there will be different challenges to address with implication on the respective excipient selection, explains Eunice Costa, director—RD Drug Product Development, Hovione. “For injectables, concentration and viscosity of subcutaneous formulations are the main points to address and optimize, whereas for oral enzymatic and acidic degradations low absorption needs to be addressed as well,” she says. “Finally, for nasal, the challenge is mainly related with the low absorption while inhalation is targeting the lung.” There has been an upswing in the proportion of drugs in the pipeline to be administered via a subcutaneous (SC) delivery route, with biomolecules that are currently administered intravenously (IV) being formulated for SC instead. “Major issues associated with SC administration for biologics are the small volumes that require high concentrations of the API,” Costa adds. “The need for high concentrations results in increases of viscosity and challenges in maintaining isotonicity of the liquid formulation as well as in preventing aggregation. Moreover, viscous formulations are difficult and painful to administer. Addressing these issues includes careful optimization of the excipients in the formulation.” For DeGrazio, there are multiple approaches available for developers of formulations to be administered subcutaneously. “One approach is through optimization of the drug formulation design,” she asserts. “This can be accomplished using technologies that help the drug meet deliverability criteria for SC injections.” Another approach includes using a suitable delivery device. “An example of this approach may be drugs that are delivered to the patient through wearable injector devices,” DeGrazio continues. “Typically, a combination of both formulation optimization, and an appropriate delivery device, facilitates the transition from IV administration to SC.” Alternative routes The size of biologic drug products—ranging from 3000 atoms to more than 25,000 atoms—has meant that the primary route of administration is via injection, states DeGrazio. “Size is a challenge for crossing the barriers into the body using other routes,” she says. “The oral route is preferred for any drug product. However, due to the sensitive nature of active ingredients, they will not survive the acidic pH and digestive enzymes of the stomach. This would be just the initial challenge, the next would be absorption into the bloodstream.” However, there are several benefits in developing biologic formulations for alternative routes of administration, argues Cacela, with probably the most obvious one being improved patient adherence. “In the development pipeline, there are increasing programs in the areas of oral, inhalation, and nasal, with the first one generally being considered as the optimal route,” she says. To overcome the enzymatic and pH-dependent degradation of drugs in the stomach, in addition to permeability issues and the potential for degradation via first pass metabolism, formulation strategies, such as enzymatic activity inhibitors, permeation enhancers, enteric coatings, and carrier molecules, can be employed, Costa reveals. “The increased focus on inhalation delivery reflects the benefits offered by this route of administration,” Costa continues. “Delivery by inhalation bypasses the harsh conditions in the gastrointestinal tract, allowing the administration of lower doses with reduced side effects, particularly for respiratory drugs delivered directly to the site of action.” For systemic delivery, administering drugs to the lungs can also allow direct absorption into the bloodstream, leading to a more rapid onset of action, Costa explains. “The main challenges for inhalation include ensuring that the drug reaches the lung (e.g., delivery efficiency), a limited array of excipients available to interact and stabilize large molecules that are safe in the lung, as well as the lack of permeability to very large biomolecules,” she says. “Overall strategies include optimal design of the inhaler device, study of the interactions between excipients and biomolecules, biomolecule engineering (e.g., fragmented antibodies, anticalins) with the purpose of maximizing efficiency.” Nasal delivery, historically, has tended to be used for local delivery of drug substances. However, Costa adds that more recently it is becoming recognized as an interesting route for direct access to the brain. “It has been actively pursued for biologics, in particular peptides, due to the ease of administration,” she states. “As opposed to inhalation, one of the major limitations of this route is the relatively limited low surface area available for absorption. To increase absorption, mucoadhesive polymers are commonly added to the formulation.” Cacela emphasizes that an overarching technological solution, useful for overcoming the limitations for the various delivery routes discussed, is the use of particle engineering. “Through the preparation of optimally sized and shaped particles, the bioavailability of the drug can be improved,” she says. “As an example, nanoparticle-based delivery systems, such as lipid nanoparticles, are used for improving penetration of large molecules. In addition, these systems provide protection to the drugs, which is particularly relevant for large molecules administered orally.” A common technique used to engineer particles is spray drying, which Cacela states is the most commercially advanced solution capable of preparing stable and effective formulations. “Despite being generally used for oral small molecules, its benefits can be easily expanded to other systems and routes of administration,” she adds. “The anticipated forecast growth for spray drying services being applied to biologics (2) is a strong indicator of that.” Reformulation and self-administration trends SC administration of biologics, in particular antibodies, is a strategy being employed by industry to improve patient comfort and provide pharmacoeconomic benefits (3), highlights Cacela. Highlighting another example (4), she adds that in some cases using SC administration can result in improved safety due to reduced adverse effects. “Besides the aforementioned benefits, reformulation of existing biologics may also be of potential value for the originators as a means of life-cycle managements,” she says. In agreement, DeGrazio notes, “We are definitely seeing the trend towards reformulation as part of lifecycle management to enable self-administration. New biologic drug products in competitive therapeutic categories are being introduced in self-administration systems. This is one of the main reasons for the growth of drug-device combination products in the marketplace.” The move toward self-administration is being driven by a number of factors, DeGrazio continues. “One of the most significant is the potential cost savings if the delivery of a drug product can be done at home, versus in a hospital or clinic,” she says. “Additional reasons include improved quality of life for patients and product differentiation in a therapeutic category.” Mitigate risks, save costs The costs associated with any medical therapy are being scrutinized by regulatory bodies, governments, and patients. Biological therapies, due to the molecular complexity and associated challenges during development means that they come with a high price tag. “One of the best ways to impact costs is by mitigating risks early in the development process,” asserts DeGrazio. “Many drug product formulators think that all problems can be solved through their ability to adjust and optimize a formulation. However, not all formulators have a broad understanding of the impact of aspects beyond the drug formulation, aspects of which they need to be cognizant.” Highlighting some examples, DeGrazio notes that formulators must be aware of the potential impact primary packaging may have on the biological drug product. Additionally, whether or not it is possible to use the drug product with a delivery device is an important consideration. “Both packaging and device options are essential when looking at improving the patient experience,” she adds. “The route chosen regarding drug pricing must not inhibit innovation and must ensure economic sustainability,” warns Cacela. “However, R&D effectiveness may be improved and, therefore, have an impact on the final cost of biologics.” To improve R&D effectiveness, Costa explains that industry is using many different approaches. “Approaches such as preclinical models that more closely resemble the human conditions to be treated, reducing late-stage (Phase II and III) attrition rates and cycle times during development by using a better model,” she says. “New tools and technologies arising from the digital transformation era, such as the application of artificial intelligence algorithms to experimental and clinical data, further improve R&D effectiveness.” Specifically looking at formulation, Costa reveals, “As more biomolecules are screened models can be improved allowing for in-silico screening and reducing the chances of failure later on in clinical development.” Still on a learning curve For Cacela there is still much to learn and more development required in both the delivery and formulation of biologics. “Besides this, the diversity of these drugs and therapies is very large and it is difficult to find a common solution even within a same class of biomolecules,” she states. “Therefore, the coming years will be marked by advances in the delivery of novel biologics, as well as biosimilars, with new solutions, new excipients, and new delivery support molecules.” “We have learned that the drug formulation itself can have a detrimental impact on the function of a delivery device, such as a prefilled syringe system,” adds DeGrazio. “By understanding issues early in the development process, however, downstream problems can be avoided. Partnership with suppliers who are familiar with such challenges can be of great benefit. An openness to engage, and learn from each other, can benefit effective drug development and the patient.” References 1. Reports and Data, “Biologics Market By Product (Monoclonal Antibodies, Vaccines, Recombinant Hormones/Proteins), By Application (Cancer, Infectious Diseases, Autoimmune diseases), By End use (Hospitals, Clinics, Diagnostic Centres), and Region, Forecasts to 2026,” Market Report, (October 2019). 2. Research and Markets, “Pharmaceutical Spray Drying Market (2nd Edition), 2018–2028,” Roots Analysis, (April 2018). 3. K. Papadmitriou, et al., Facts Views Vis. Obgyn., 7 (3) 176–180 (2015). 4. P. Moreau, et al., Lancet Oncol., 12 (5) 431–440 (2011). Article Details Pharmaceutical Technology Vol. 44, No. 1 January 2020 Pages: 33–35 Citation When referring to this article, please cite it as F. Thomas, “Fresh Thinking in Biologic Drug Formulation,” Pharmaceutical Technology 44 (1) 2020.   Read the article on Pharmaceutical Technology's website  


Fresh Thinking in Biologic Drug Formulation

Jan 02, 2020

Contact Us

If you would like to learn more about Hovione, kindly fill in the form below and we will be revert to you soon.