Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Reshaping Dosage Forms

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

Frontrunners in Bispecific Antibodies

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Articles

EMA has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.

EMA Invites Comments on New Guidance for Vaccine Development

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Customers are looking to reduce risk, increase performance, and optimize productivity.

Risk Reduction Top Driver for Biopharmaceutical Raw Material Development

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

Changes and Challenges for Generic Drugs

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Experts from Capsugel and Catalent discuss the rationale of using lipid0basd formulations to improve the oral bioavailability of poorly soluble drugs.

Bioavailability Enhancement with Lipid-Based Drug-Delivery Systems

With a number of branded biologics hanging at the patent cliff, the future looks promising for biosimilars.

Biosimilar Development: 10 Years On

Friedrich Haefele, PhD, is head of Biopharma Fill & Finish Germany for Boehringer Ingelheim.

Innovative therapeutic approaches beyond mAbs will require new methods for future facility construction.

Maturing Aseptic Technologies Create More Flexible Facilities

Steve Deakin is Business Development Director at I Holland.

Tool coatings are now seen as an acceptable means of solving production problems, such as sticking and corrosion, resulting in increased product yield.

Trends in Tablet Tooling

Tim Freeman is Managing Director of powder characterization company Freeman Technology for whom he has worked since the late 1990s. He was instrumental in the original design and continuing development of the FT4 Powder RheometerÂ® and through his work with various professional bodies, and involvement in industry initiatives, is an established contributor to wider developments in powder processing.Tim has a degree in Mechatronics from the University of Sussex in the UK. He is a mentor on a number of project groups for the Engineering Research Center for Structured Organic Particulate Systems in the US and a frequent contributor to industry conferences in the area of powder characterisation and processing. A past Chair of the American Association of Pharmaceutical Scientists (AAPS) Process Analytical Technology Focus Group Tim is a member of the Editorial Advisory Board of Pharmaceutical Technology and features on the Industry Expert Panel in European Pharmaceutical Review magazine. Tim is also a committee member of the Particle Technology Special Interest Group at the Institute of Chemical Engineers, Vice-Chair of the D18.24 sub-committee on the Characterization and Handling of Powders and Bulk Solids at ASTM and a member of the United States Pharmacopeial (USP) General Chapters Physical Analysis Expert Committee (GC-PA EC).

Efforts to tackle challenges in tablet manufacture are shaped by quality by design (QbD) and continuous manufacturing.

Tableting—a Focus for Continuous Improvement

Virginia Acha, DPhil, is director of regulatory policy, Europe, Middle East and Africa, at Amgen.

To realise the full potential for biosimilars, stakeholders must build a better understanding of biosimilars and to take a comprehensive view of how these important medicines can fit into treatment pathways.

Emerging Opportunities with Biosimilars

Stephen Tindal is director, Formulation and Site R&D Lead at Catalent Pharma Solutions.

Stephen Tindal from Catalent Pharma Solutions speaks with Pharmaceutical Technology Europe about advances in softgel technologies.