Press Room

Lisbon, Portugal, 5th December 2013. Hovione announced today the expansion of its inhalation drug product development services with the introduction of a high precision MG2 FlexaLAB capsule filling machine. This investment is in response to market demand for high-precision, capsule filling services for inhaled products and is the last step in Hovione’s plan to offer development services in all quadrants of inhalation projects: from API to formulation to powder inhalers to final unit dose. This investment intends to support Phase II-Phase III clinical trials to Hovione’s business partners. “We give our customers an edge in inhalation capsule filling for drug delivery to the lung, by providing access to a machine capable of very high precision filling of low doses, down to 5 mg. We are perhaps the only independent company with expertise in every aspect of the inhaled drug development process and this acquisition strengthens our commitment to inhalation drug development”, said Peter Villax, Vice-President. Hovione is currently executing inhaled drug development projects for a number of pharmaceutical companies, involving API process development, particle engineering, formulation development and clinical supplies. Capable of filling up to 3,000 capsules/hour, the FlexaLAB is the first MG2 equipment fitted with the MultiNET system, which allows 100% net weight unit verification for increased precision and suitable internal process controls for supporting inhalation development activities. Gonçalo Andrade, Business Development Manager, said “Hovione has a proven track record in the field of inhalation product development. With our core API process development, particle engineering and manufacturing expertise, Hovione produces pulmonary delivery-friendly particles which can then be used to fill inhalation capsules. The acquisition of the MG2 FlexaLAB unit allows Hovione to support capsule filling activities in all stages of clinical development and even low volume commercial manufacturing of inhalation drug products. Customers can now partner with Hovione for a full service inhalation drug development manufacturing, all under one roof.” About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers in the most regulated markets. Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services. More about Hovione at www.hovione.com Contacts at Hovione:  Gonçalo Andrade, PhD MBA  Business Development Manager  gandrade@hovione.com +351 219 847 619 Isabel Pina Director Corporate Communications  ipina@hovione.com +351 21 982 9362  

Press Release

New inhalation capsule filling machine fills market gap

Dec 05, 2013

With an increasing number of relatively insoluble drugs in development today, there is a need to develop and use platform technologies capable of addressing solubility issues. Among the different alternatives, the use of stabilised amorphous solid dispersions is becoming increasingly popular, with pharmaceutical spray drying being one of the key technologies used in their preparation. In spray dried dispersions (SDD), the active pharmaceutical ingredient (API) is molecularly dispersed in a polymeric matrix. The polymer is used to stabilise the amorphous, metastable form of the drug and sustain supersaturation of the API in solution/biological fluids, thereby increasing bioavailability. Read article here

Article
European Industrial Pharmacy, December 2013

Scale-up of spray dried amorphous solid dispersions

Dec 01, 2013

Loures, Portugal, October 2nd, 2013 – Hovione's plant in Loures, Portugal has successfully passed a GMP and Postmarket Approval inspection by FDA. The inspection, carried out by Mrs. Yumi Hiramine, Inspector from CDER, lasted 5 days as initially planned, starting on 23rd September and concluded on the 27th. No Form 483 was issued. At the closing meeting the inspector informed that she was satisfied with what she had seen and complimented Hovione on its GMP System, inspection organization and the knowledge of its team members. “We are pleased to have another successful FDA inspection at our Loures plant completed," said Guy Villax, Hovione’s CEO. "Doing well in the eyes of an FDA inspector is always a motive of satisfaction and a good reason to congratulate one’s team – well done!; but with 65 client audits and inspections per year our sites are always inspection-ready”. Hovione’s 5 plants were the object of 12 inspections in the last 18 months. These inspections were performed by some of the world’s major Health Authorities:  Five by the US FDA in Portugal, Ireland Macau and New Jersey – 4 of them with no Form 483 issued;  Three by the Portuguese Health Authority (INFARMED) in Portugal, Macau and China, which led to GMP certificates granted to each of the sites;  One by the Irish Medicines Board (IMB) in our Cork plant, which ended with the issuance of GMP certificates; One by the Korean FDA in the Portuguese plant; Two by the CFDA in China. Luisa Paulo, Hovione’s Compliance Director said “the main objective of theses inspections was to evaluate how the guidelines and internal procedures are followed in day-to-day plant operations. Special emphasis was given to how the Company records and manages OOS, deviations, change control, batch production records, complaints, validation and product quality reviews. The Inspectors were always pleased to see consistency between daily practice and the quality system”. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers in the most regulated markets. Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services. For more information about Hovione, please visit www.hovione.com  or contact Marketing & Communication, Isabel Pina, + 351 21 982 9362, e-mail: ipina@hovione.com . Follow Hovione on Twitter @HovioneGroup and LinkedIn. 

Press Release
The 12th successful inspection in 18 months

Another successful FDA inspection at a Hovione site

Oct 02, 2013

  Lisbon, 11 September 2013. Hovione announced today that the European Patent Office has granted a patent for Hovione’s XCaps, a dry powder inhaler (DPI). XCaps addresses a pulmonary inhalation market need for a very inexpensive device which combines high efficiency in powder dispersion with ease of use. Lung fractions in excess of 70% have been achieved, from a device which only requires two steps to inhalation and which only has two components plus a dust cover. This makes XCaps highly suited for inhalation applications where minimal training of patients is desirable and has the versatility to treat almost all pulmonary diseases, including asthma, COPD as well as infection, which typically require very large dose delivery. XCaps follows on the heels of another successful Hovione DPI, TwinCaps®, which was developed specifically for an influenza application and is licensed to Daiichi Sankyo and Biota for this application. Hovione is offering XCaps as a part of its inhalation device portfolio, allowing its integration with a drug product development program, allowing business partners to take their candidate drugs from the API stage all the way to the unit dose, with a single partner. Peter Villax, Vice-President and co-inventor of the device, said “We give our customers an edge in speed of development because we are perhaps the only independent company developing DPIs with expertise in every aspect of the inhaled drug development process. Granting of the European Patent on the XCaps inhaler, within 30 months after initial filing, underpins Hovione’s capabilities in innovation and intellectual property management, to successfully design, develop and deliver innovative products, namely, a quality inhalation device, addressing a market need”. “The XCaps addresses a gap for a simple, easy to use, cost effective, multiple use, capsule based inhalation device. This allows our business partners to take advantage of additional patent protection for their inhalation drug product and effective drug product life cycle management” said Gonçalo Andrade, Business Development Manager. Hovione is currently executing inhaled drug development projects for multiple pharmaceutical companies, involving API process development, particle engineering, formulation and clinical supplies and is looking for partners willing to incorporate the XCaps into their inhalation drug development. Find more about XCaps.   About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers in the most regulated markets. Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

Press Release

Hovione: EPO grants a new inhaler patent

Sep 11, 2013

In this work, the potential of spray congealing in microencapsulation, taste masking and controlled release was explored and compared to other commonly used technologies, specifically spray drying and hot melt extrusion. The ability to control powder characteristics without the need of subsequent downstream processing methods is a marked advantage over other “particle-engineering” technologies. Moreover, spray congealing is an environmentally friendly process where high throughputs can be achieved. This technology involves some critical stages that should be thoroughly evaluated when establishing the process, namely the atomization, cooling and feed stages. Spray congealing represents a very attractive and promising platform to address some of the challenges related to drug development and drug life cycle management. Read article here

Article
Chemistry Today, September/October 2013

Spray congealing: applications in the Pharmaceutical Industry

Sep 01, 2013

The changing development paradigm resulting from the US Food and Drug Administration’s quality-by-design (QbD) initiative and International Conference on Harmonisation (ICH) guidelines requires increased process understanding of the drug substance and drug product throughout development and manufacturing. A lack of information can result in delays in regulatory approval and higher costs. Applying QbD principles leads to greater process understanding, facilitates regulatory approval and streamlines postapproval changes. Case studies on the manufacture of a bulk powder and the development of a tablet show the application of QbD principles, including defining critical quality attributes, implementing risk assessment, optimising process development, developing a design space and performing a criticality analysis. Read article here

Article
Pharmaceutical Technology Europe, September 2013

Optimising Quality by Design in Bulk Powders and Solid Dosage

Sep 01, 2013

Loures, Portugal, 7 June 2013 – Hovione today announced the appointment of Dr. Justin Hughey to lead the Particle Design sciences at our site in New Jersey. With over 30 publications, posters and book chapters Dr. Hughey is an acknowledged expert in the field of solubilization including the creation of amorphous solid dispersions with emphasis on Hot Melt Extrusion. Dr. Hughey most recently served as the Director of Research for Austin-based Enavail.  To complement its spray drying capabilities and other technologies to improve bioavailability, Hovione is investing in both lab and mid-scale Hot Melt Extruders to enable the efficient development of particles with improved solubility with seamless scale up and transfer to clinical manufacture.  “I am delighted to announce the appointment of Dr. Hughey. With his experience and deep scientific knowledge in developing traditional and non-traditional dosage forms with a strong emphasis on Hot Melt Extrusion and other novel processing techniques, I believe he will help speedily solve bioavailability challenges brought to us by our customers”, said Dr. Colin Minchom, Vice President Particle Design. “I am excited about the opportunity to lead the scientific efforts of the Particle Design team at Hovione New Jersey. I have always admired Hovione’s capabilities in the area of spray drying and was pleased to hear that they were adding Hot Melt Extrusion to their portfolio. I am looking forward to making significant contributions to this area and offering customers a range of solubility enhancement options, thus improving the probability of success for their molecule” said Dr. Hughey. Dr. Hughey earned his Ph.D. in Pharmaceutics from The University of Texas at Austin under the supervision of James W. McGinity and also holds B.S. degrees in Chemical Engineering and Chemistry. His pharmaceutical development experience extends to particle engineering technologies for pulmonary delivery as well as controlled and immediate release solid oral dosage forms.  About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers in the most regulated markets. Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services. For more information about Hovione, please visit www.hovione.com or contact Marketing & Communication, Isabel Pina, + 351 21 982 9362, e-mail:ipina@hovione.com . Follow Hovione on Twitter @HovioneGroup and LinkedIn.    

Press Release

Hovione Announces the Appointment of Justin Hughey, PhD to lead Particle Design in the USA

Jun 07, 2013

The interface between the Active Pharmaceutical Ingredients (API) manufacturing and formulation development is of paramount importance in the pharmaceutical world. Chemists, engineers and formulators are not exposed, by training, to the same challenges. As presented in Figure 1, on the one hand there are API suppliers, characterized by a service orientation mindset, used to addressing synthesis route issues (e.g. impurities, yields), solid state characterization (e.g. polymorphs, polymorph control), raw material sourcing, etc); on the other hand, formulators are used to a different type of language and daily concerns (e.g. bioavailability, patience compliance, administration route, efficacy and processibility). Read article here  

Article
European Industrial Pharmacy, June 2013

Bridging API manufacturing and formulation through particle design

Jun 01, 2013

The role of empirical and mechanistic modeling The purpose of this work was to build different models to predict the particle size of spray dried powders and assess their usefulness in the design space establishment. Powders were obtained by spray drying solutions of a known pharmaceutical excipient (hypromellose phthalate). The powders were characterized by image analysis (for particle size and circularity), loss on drying (for residual solvent content) and helium pycnometry (for particles density). A full factorial experimental design was performed and PLS regression was used to establish a statistical model. In addition, mechanistic modeling of droplet formation based on hydrodynamic instabilities was also used to estimate the size of particles. Spherical particles, with average particle size between 3 and 9 ?m, were obtained by spray drying solutions in a lab scale unit. Particle density and residual solvent content did not vary significantly between experiments. Statistical and mechanistic approaches were compared. Both statistical and mechanistic models were able to describe the results observed, although the mechanistic model was the most accurate. The mechanistic description of droplet formation was of great assistance to understand and describe the spray drying process.   Introduction Spray drying is a well-established and widely applied technology to manufacture a wide range of powders. It is an ideal process when the end-product quality comprises attributes such as well-defined particle size distribution, residual solvent content, bulk density and morphology (1). Spray drying involves the atomization of a liquid stream (i.e. dispersion of the liquid into very small droplets) into a chamber where the droplets are contacted with a hot gas stream leading to flash drying and particle formation (2). Efforts to understand the physical principles of spray drying were intensified in the last decade with the aim of improving powders attributes and speed up product and process development. Due to the remarkable flexibility of the technology the use of spray drying is increasing in the pharmaceutical industry. It is being used to produce, among others, amorphous materials with enhanced bioavailability, microencapsulated drugs and powders for inhalation (3). In most of the spray drying applications the particle size is considered a critical quality attribute, e.g. for inhaled or oral drugs where it affects drug aerodynamic or compr ...   Read entire article

Article
Chemistry Today, March/April 2013

Applying Quality by Design to spray drying

May 01, 2013

Lisbon, Portugal, 3rd April 2013 - Hovione today announced a co-promotion and collaboration agreement with Ligand to provide Hovione’s customers efficient access to Captisol® technology. Captisol, a chemically modified cyclodextrin, is proven to improve the solubility and stability of drugs and is currently used in six marketed products. Hovione offers innovative particle engineering technologies to improve the solubility of modern drugs. The agreement allows Hovione to use Captisol technology in its solubilization programs, which include amorphous solid dispersions, crystal design and size reduction and control of particle size. By adding this new technology, it increases the likelihood of solving the molecule’s bioavailability challenges. “Hovione is delighted to announce the ability to provide access to Captisol.There is no single solution to improving bioavailability and for a customer to access diverse options with a single supplier provides for greater probability of success and speedier outcomes,” said Dr. Colin Minchom, Hovione’s Vice President of Particle Design. “Hovione has manufactured Captisol for more than a decade, and we are very pleased to expand our partnership to help customers succeed. Providing for greater access to Captisol should efficiently enable the successful development of more poorly soluble molecules and further increase our Captisol partnership portfolio,” said Mr. Mathew W. Foehr, Ligand’s Executive Vice President and Chief Operating Officer. About Captisol®  Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists at the University of Kansas' Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled six FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis™, Baxter International's Nexterone® and Pfizer's Vfend® IV. There are currently more than 30 Captisol-enabled products in development, including Lundbeck’s carbamazepine IV, The Medicines Company's MDCO-157 and Rib-X's delafloxacin IV program. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers in the most regulated markets. Hovione offers integrated API, particle design,formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services. For more information about Hovione, please visit www.hovione.com or contact Marketing & Communication, Isabel Pina, + 351 21 982 9362, e-mail: ipina@hovione.com . Follow Hovione on Twitter @HovioneGroup and LinkedIn. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company that develops and acquires assets it believes will generate royalty revenues and, under its lean corporate cost structure, produce sustainable profitability. Ligand has a diverse asset portfolio addressing the unmet medical needs of patients for a broad spectrum of diseases including thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia, anemia and osteoporosis. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Please visit www.captisol.com for more information on Captisol or www.ligand.com for more information on Ligand. Follow Ligand on Twitter @Ligand_LGND.    

Press Release

Hovione announces a co-promotion and collaboration agreement with Ligand for Captisol®

Apr 03, 2013

The concept and terminology of Quality by Design (QbD) have become part of the common language of those working in the pharmaceuticals industry. This ambitious initiative aims to bring the industry to a higher level of innovation and process control through a better process understanding and thus to develop improved processes with positive implications in terms of process capability, sustainability and cost-efficiency.  

Article
Speciality Chemicals Magazine, January 2013

Quality by Design in API process development

Jan 15, 2013

Lisbon, Portugal, 3rd April 2013 - Hovione today announced a co-promotion and collaboration agreement with Ligand to provide Hovione’s customers efficient access to Captisol® technology. Captisol, a chemically modified cyclodextrin, is proven to improve the solubility and stability of drugs and is currently used in six marketed products. Hovione offers innovative particle engineering technologies to improve the solubility of modern drugs. The agreement allows Hovione to use Captisol technology in its solubilization programs, which include amorphous solid dispersions, crystal design and size reduction and control of particle size. By adding this new technology, it increases the likelihood of solving the molecule’s bioavailability challenges. “Hovione is delighted to announce the ability to provide access to Captisol.There is no single solution to improving bioavailability and for a customer to access diverse options with a single supplier provides for greater probability of success and speedier outcomes,” said Dr. Colin Minchom, Hovione’s Vice President of Particle Design. “Hovione has manufactured Captisol for more than a decade, and we are very pleased to expand our partnership to help customers succeed. Providing for greater access to Captisol should efficiently enable the successful development of more poorly soluble molecules and further increase our Captisol partnership portfolio,” said Mr. Mathew W. Foehr, Ligand’s Executive Vice President and Chief Operating Officer. About Captisol®  Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists at the University of Kansas' Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled six FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis™, Baxter International's Nexterone® and Pfizer's Vfend® IV. There are currently more than 30 Captisol-enabled products in development, including Lundbeck’s carbamazepine IV, The Medicines Company's MDCO-157 and Rib-X's delafloxacin IV program. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers in the most regulated markets. Hovione offers integrated API, particle design,formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services. For more information about Hovione, please visit www.hovione.com or contact Marketing & Communication, Isabel Pina, + 351 21 982 9362, e-mail: ipina@hovione.com . Follow Hovione on Twitter @HovioneGroup and LinkedIn. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company that develops and acquires assets it believes will generate royalty revenues and, under its lean corporate cost structure, produce sustainable profitability. Ligand has a diverse asset portfolio addressing the unmet medical needs of patients for a broad spectrum of diseases including thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia, anemia and osteoporosis. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Please visit www.captisol.com for more information on Captisol or www.ligand.com for more information on Ligand. Follow Ligand on Twitter @Ligand_LGND.    

Press Release

Hovione and Solvias announce a collaboration to provide for improved drug solubility

Nov 28, 2012

Interview: Colin Minchom, VP, Particle Design Business Unit “An issue for customers with a poorly soluble molecule is that any one solubility enhancement technology is likely to have, I believe, a 20% to 40% probability of solving the problem. This means that in order to assure acceptable bioavailability, at least three technologies need to be investigated. The customer would need to contract with three single platform technology companies or be able to engage a single company, such as Hovione, that can apply multiple platforms, to increase the probability of solving the  problem, and deliver the desired outcome.” Read article here

Article
Drug Development and Delivery, October 2012

New Technologies in Particle Design

Oct 31, 2012

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