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

Articles

Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.

Seqirus Opens Corporate Headquarters in the United Kingdom

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.

Achieving Balance in Sterile Product Manufacturing

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes.

Determining Biosimilarity

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

The advantages of fixed-dose combinations are well recognized but their formulation and manufacture can be a challenge, Stefania Barzanti from IMA Active explains why.

Fixed-Dose Combinations

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

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.