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

Genzyme Sells Business Unit to Sekisui Chemical; Ablexis Names VP of Research; and More.

Week of Nov. 22, 2010: Company and People Notes: Genzyme Sells Business Unit to Sekisui Chemical; Ablexis Names VP of Research; and More.

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The International Conference on Harmonization (ICH) Steering Committee (SC) and its working groups met in Fukuoka, Japan Nov. 6-11, 2010.

ICH Meets in Japan

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

European confidence and optimism in biotechnology is increasing, according to a survey conducted by the European Commission.

Survey Shows Europe's Perception of Biotechnology to be Favorable

The European Medicines Agency and the Massachusetts Institute of Technology's (MIT's) Center for Biomedical Innovation (CBI) and Center for International Studies (CIS) are launching a collaborative research project with a focus on enhancing regulatory science in pharmaceuticals, according to an EMA press release.

EMA, MIT Form Research Project for Regulatory Science

During the 20 months before the crisis of contaminated heparin in early 2008, the US Food and Drug Administration did not inspect any Chinese heparin firms, according to a US Government Accountability Office, (GAO) report.

GAO Evaluates FDA's Response to 2008 Heparin Crisis

Roche Details Restructuring Plan; Sigma-Aldrich Names Successors after CEO's Death; and More.

Week of Nov. 15, 2010: Company and People Notes: Roche Details Restructuring Plan; Sigma-Aldrich Names Successors after CEO's Death; and More.

The biotechnology company Biogen Idec (Weston, MA) announced last week a major restructuring program that will refocus the company's research and development (R&D) programs, consolidate facilities, and reduce its workforce.

Biogen Idec Announces Restructuring Program

PQRI and FDA present Process Drift Workshop, and More.

Regulatory Roundup: PQRI and FDA present Process Drift Workshop, and More.

The US Food and Drug Administration's Puerto Rico district office "may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," according to Rep. Edolphus Towns (D-NY), chair of the US House of Representatives Committee on Oversight and Government Reform.

Lawmakers Question the Activities of FDA's Puerto Rico Office

Eli Lilly Acquires Avid Radiopharmaceuticals; EMA Recruiting New Director; and More

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes