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

Topic

Articles

Also: Sanofi-aventis acquires BiPar Sciences; FDA issues Warning Letter to Chinese heparin manufacturer; Halo Pharmaceutical appoints chief scientific officer; more...

Company and People Notes: GSK Acquires Stiefel Laboratories; Roche Announces Changes at Genentech; More...

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The United States Pharmacopeial (USP) Convention signed a memorandum of understanding (MOU) with the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) last week in Moscow.

USP Forms Collaboration with Russia

Also, Sanofi-aventis acquires Medley and Laboratorios Kendrick; Eli Lilly's Cook to retire from board; more...

Company and People Notes: DSM and Shire Form Pact; Pfizer Names Oncology Unit Exec; More...

Pfizer outlined the progress of its late-stage pipeline last week and announced this week plans to separate its research activities into two organizations, one focused on small molecules and the other on biologics, pending the closure of its pending acquisition with Wyeth.

Pfizer to Divide Research Activities into Two Branches; Provides Pipeline Update

Also, Genzyme and Bayer HealthCare form agreement; FDA releases draft guidances; TransMolecular appointed Robert Radie president and CEO

Company and People Notes: BMS and Otsuka Extend Abilify Agreement; Takeda Reorganizes Corporate Structure; More...

The authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.

Silicone Microdroplets in Protein Formulations—Detection and Enumeration

Also, SOCMA changes name; two FDA approvals; Biogen Idec names chief operating officer; more...

Company and People Notes: EMD Serono to Open Cambridge, MA, site; Akorn Appoints Interim CEO; More...

The author reviews the types of reference-standard materials used in drug-product manufacturing, discusses current regulatory requirements, and outlines a reference-standard qualification program.

Reference-Standard Material Qualification

Brief pharmaceutical news items for April 2009.

Pharma Capsules

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

FDA is poised to gain authority and resources to ensure the quality of food and drugs.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes