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

Topic

Sean Milmo is a freelance writer based in Essex, UK.

Articles

Finalizing GMP requirements and quality standards for the development,
manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.

GMP Challenges for Advanced Therapy Medicinal Products

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.

Litigation and Manufacturing Hurdles Block US Biosimilars Market Success

Agnes Shanley is senior editor of Pharmaceutical Technology.

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

Optimizing Semisolid Dosage Forms

Andrew Teasdale, PhD, is a Principle Scientist at AstraZeneca.

Laura Rutter is a SM manager, analytical services at GlaxoSmithKline

Courtney M. Callis is research scientist, Health/ Safety/Environmental, Lilly Research Laboratories

Bruce D. Naumann is executive director, Toxicology, Merck & Co.;

Gretchen Allison is a senior director in Global Quality Operations at Pfizer Inc.

Wendy Luo is an associate director, Drug Safety Evaluation, Bristol-Myers Squibb;

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

EMA Guideline on Setting Health-Based Exposure Limits

While some industry trade groups are gunning for distinct, nonproprietary names for biosimilars (mostly providers, brand manufacturers, and patient advocacy groups), and others for common names (mostly biosimilar manufacturers, insurers, pharmacies, and the Federal Trade Commission [FTC]), some are requesting that no decisions be made at all at this stage in the game. Express Scripts, a large pharmacy benefit manager (PBM), submitted a comment to FDA asking that the regulatory agency hold off on naming decisions until it releases formal guidance on interchangeability first.

Express Scripts to FDA: Hold Off on Biosimilar Naming Decisions for Now

Copley Scientific’s new Vertical Diffusion Cell Test System Model HDT 1000 comprises a compact unit with 10 test stations that enables the precise control of test conditions.

Vertical Diffusion Cell Test System

A study backed by the Centre of Regenerative Medicine found that laminins are crucial cell components that could help aid the commercial production of stem cell therapies.

Laminins Key to Production-Scale Stem Cell Development

With the acquisition of Medipac’s tube filling assets for effervescent tablets, Romaco can now offer the complete line configurations for effervescent tablets.

Romaco Acquires Medipac AB and Extends Position in Effervescent Tablets Sector

Text from a merger prospectus reveals the termination fee for the proposed Pfizer-Allergan deal would change if any new tax regulations were passed prior to the closing of the transaction.