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

Kim Shah is VP Marketing, Informatics, Thermo Fisher Scientific (USA). marketing.informatics@thermofisher.com

Articles

With pressure to cut costs, shorten the pipeline life cycle and maximize return on investment, pharmaceutical manufacturers need tools that help them improve enterprise-wide communications, reach critical decisions faster and produce timely, accurate reports on how compounds are progressing.

Elevating laboratory informatics to assist decision-making

Michael Waddington is vice-president of business development at Accugenix, 223 Lake Drive, Newark, DE 19702, tel. 302.292.8888.

Identification of fungi, especially filamentous fungi, has been a very difficult task. Because of the amount of experience required to accurately identify filamentous fungi to the species level, it has become acceptable to either identify these organisms to the genus level or, in some cases, simply identify them as "molds."

Identification of Fungi Using Ribosomal Internal Transcribed Space DNA Sequences

Also, Roche's Avastin trial does not meet endpoint; Innate Pharma names regulatory VP; more...

Company and People Notes: CIGNA and Merck Agree on Drug Pricing Plan; Kathleen Sebelius Confirmed as head of HHS; More

Angie Drakulich was editorial director of Pharmaceutical Technology.

The US Food and Drug Administration has agreed to address some core industry questions regarding the changes made to US Pharmacopeia General Chapter <467> in July 2008.

FDA Answers Key Residual-Solvent Testing Questions

The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the common technical document (CTD) format, including the electronic CTD (eCTD).

FDA Issues Guidance on Summaries for CTD-based Submissions

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

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes