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

Brian Mullan is the chief technical officer of Yposkesi, an SK Pharmteco company.

Articles

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

Choosing the Right CDMO for CGT Programs 

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

WHO Grants Prequalification to GSK’s Malaria Vaccine

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Creating building blocks for good manufacturing practices is essential.

Building GMPs for Solid Dosage

Moderna is suing Pfizer and BioNTech for allegedly infringing on patents the company filed from 2010 to 2016.

Moderna Files Suit Against Pfizer and BioNTech

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

European Commission Approves Bevacizumab Biosimilar from Celltrion Healthcare

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

Biosimilar data analysis must demonstrate a correlation between structure and function.

Developing Methods for Analyzing Biosimilars

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Technological advances are progressing pharmaceutical packaging to overcome the challenges of the future.

Getting Proactive with Pharma Packaging

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

This article is focused on introducing a control chart technique using relative standard deviation (RSD) statistics (i.e., RSD chart); in other words, a coefficient of variation chart for continued process verification. 

Application of RSD Charts for Content Uniformity Data in Continued Process Verification

Biologics are forming a greater proportion of the development pipeline, but there are still some formulation difficulties to overcome to ensure clinical and commercial success.

Formulating Biologics: A Learning Curve 

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.