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

The US Food and Drug Administration sent Bayer Schering Pharma (Berlin) a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients (APIs).

Bayer Receives Warning Letter for Alleged Deviations

Company and People Notes: Sanofi Pasteur signs H1N1 vaccine deal with Brazilian government; Helsinn Group appoints CEO of US business; more...

Week of Sept. 14, 2009: Evotec and Biogen Idec Form Pact; Marijn Dekkers Leaves Thermo Fisher Scientific for Bayer; More...

Company and People Notes: Neoprobe and Laureate Pharma form manufacturing agreement; Akela Pharma appoints CEO and chairman; more...

Week of Sept. 7, 2009: Facet Rejects Biogen Idec's Proposal; Roche Announces Management Changes; More...

Also, Orexo and Novartis form agreement; Affitech appoints Robert Burns CEO; more...

Week of Aug. 31, 2009: Roche Purchases Lonza Facility; SCOLR Pharma Names CEO; More...

Brief pharmaceutical news items for September 2009.

Pharma Capsules

Michelle Hoffman, editorial director of Pharmaceutical Technology.

After years of promomting QbD concepts, FDA's ready to take action on nonconformers.

Quality by Enforcement

Angie Drakulich was editorial director of Pharmaceutical Technology.

As new process validation guidelines emerge, industry needs to reinvent how it releases product.

The Go/No-Go Mindset

IPEC's new stability testing guide takes into account the full supply chain's storage conditions.

Inside IPEC–Americas: Evaluating Excipient Stability

Peter Woods is Programme manager at GB Innomech Ltd (UK).

David Beale is Technical Director at GB Innomech Ltd (UK).

When validating automated systems from third-party providers, using the V model and failure modes effects and criticality analysis (FMECA) early in the process can help.

The benefits of risk-based analyses during system validation

Company and People Notes: UCB and Novartis form agreement; AAIPharma appoints VP of regulatory affairs; more...

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes