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

Jim Greenwood is president and CEO of the Biotechnology Innovation Organization (BIO). He represented Pennsylvania’s 8thÂ district in the US House of Representatives from 1993 to 2005.

Articles

The president of BIO proposes the ingredients needed for industry growth.

Biotechnology in 2009

Hsiang Yu Hsieh is a graduate student at National Central University, 300 Jhong-Da Rd., Jhong-Li City 320, Taiwan, ROC.

Yan Chan Su is a graduate student at National Central University, 300 Jhong-Da Rd., Jhong-Li City 320, Taiwan, ROC.

Hung Ju Hou is a graduate student at National Central University, 300 Jhong-Da Rd., Jhong-Li City 320, Taiwan, ROC.

The authors describe the importance of a rapid and an abbreviated screening strategy by initial solvent screening in 20-mL scintillation vials.

Initial Solvent Screening of Carbamazepine, Cimetidine, and Phenylbutazone: Part 1 of 2

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Manufacturers of therapeutic monoclonal antibodies consider new paradigms in purification technologies.

Easing the Bottleneck

The organizations' presidents discuss market exclusivity, approval processes, and pending legislation.

Industry Leaders Debate Follow-on Biologics Pathway

Technology can solve enterprise-level problems.

Shop Floor and Top Floor, Unite!

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

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).

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes