Drug Development

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.

Articles

This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

Justification of Using Weight Variation Instead of Content Uniformity for Release of Relevant OSD Forms

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

Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.

Influencing Change in Drug Delivery

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

Eli Lilly to Cap Out-Of-Pocket Insulin Costs at $35

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

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Vaccine Development Builds on COVID-19 Breakthroughs

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA. 

Investigational Personalized mRNA Cancer Vaccine Gains Breakthrough Therapy Designation from FDA

Podcasts

In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.

Drug Solutions Podcast: Progressing Excipients Through Review

is an executive director at WuXi Biologics.

Wesley Wang is vice-president at WuXi Biologics.

Weichang Zhou is president at WuXi Biologics.

In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.

Current Trends in Host Cell Protein Detection for Biologics Manufacturing

Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.

FDA Publishes New Product-Specific Guidelines for Generic Drug Development

Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.

CROs Gaining a Competitive Edge

Marina Necdina has more than 10 years of exerience as a bench scientist specializing in the areas of biochemistry, cell biology, and drug manufacturing.

The COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential.  There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage. 

Formulation and Drug Delivery