There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

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Articles

By reducing cycle time and implementing quality-by-design inspired engineering, advanced lyophilization systems are driving the industry toward greater efficiency and control.

Deep Freeze: Innovations in Lyophilization

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Standards data is helpful, but FDA needs to apply its information across the board. This article contains bonus online-exclusive material.

Insider Solutions: Device Database Can Help Pharma

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Obama's cost-containment and science-innovation initiatives need to overlap.

Parallel Tracks

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The financial and economic downturn is likey to have long-term implications for outsourcing.

Moving Toward a Drug Development Boon or Bust?

Operational excellence awaits, but only if you can implement PAT successfully.

Managing the risks of PAT

The authors examine common superdisintegrants (i.e., crospovidone Type A, crospovidone Type B, croscarmellose sodium, and sodium starch glycolate) with a set of poorly soluble drug actives and evaluate in vitro drug dissolution.

Influence of Superdisintegrants on the Rate of Drug Dissolution from Oral Solid Dosage Forms

Also, Hospira to reduce workforce; WuXi AppTech makes senior appointments; more...

Company and People Notes: Daiichi Sankyo Sues 13 Generic Drugmakers; Ischemix Appoints CEO; More...

A bipartisan bill that would establish a regulatory pathway for the approval of biosimilars was introduced into the US House of Representatives last week.

Bipartisan Bill for Biosimiliars and Biogenerics Introduced in the House

The US Pharmacopeial Convention (USP) and the National Institute for the Control of Pharmaceutical Biological Products (NICPBP), China's agency for overseeing the quality of large- and small-molecule drugs, signed a memorandum of understanding (MOU) to bolster the quality of medicines in China and in the countries that buy Chinese drug products, including the United States.

USP and NICPBP Sign Memorandum of Understanding

Also, Genzyme receives warning letter; Mesa Laboratories appoints John J. Sullivan CEO and a member of the board of directors; more...

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes