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

An updated book provides essential information for scientists who monitor microbial quality.

No Excuse for Nonconformance

Norma Leyva is a senior scientist at Pfizer, Inc.

The authors present a simple and material-sparing approach for estimating the powder-flow performance of previously uncharacterized single-component bulk powders when only particle-size distribution data are available.

Modeling Pharmaceutical Powder-Flow Performance Using Particle-Size Distribution Data

An LC&#150;MS/MS method for the quantitative determination of vitamin D3 in human plasma has been developed and validated with positive atmospheric chemical ionization sources.

LC–MS/MS method for the determination of Vitamin D3 in human plasma

PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?

PAT: HPLC on the horizon?

Development & Validation of an Inductively coupled Mass Spectrometric Method-ABC Labs Whitepaper

Also, GPC Biotech AG and Agennix to merge; BASi appoints COO of scientific services; more...

Company and People Notes: Genentech Tells Shareholders to Reject Roche's Tender Offer; Cryoport Appoints President and CEO; More...

Also, Sandoz received approval for its third biosimilar from the EU, WuXi PharmaTech's CFO Benson Tsang to leave at month's end; more...

Company and People Notes: KV Pharmaceutical Restructures; Otsuka America Appoints Mark Altmeyer President and CEO; More...

Justin Neway, PhD, is executive vice-president and chief science officer at Aegis Analytical Corporation.

To implement QbD and reduce business risks, teams should begin QbD collaboration early during process development.

Bridging the Development–Manufacturing Gap to Achieve QbD and PAT

Congressman John D. Dingell (D-MI) introduced HR 759, known as the Food and Drug Globalization Act of 2009, which would amend the Food, Drug, and Cosmetic Act to address food, drug, and device safety, including registration of producers of drugs and applicable fees, documentation for admissibility of drug imports, country of origin labeling, and the inspection of producers of drugs and active pharmaceutical ingredients (API).

Congress Introduces FDA Globalization Act of 2009

Also, PPD to acquire AbC.R.O.; Bilcare Global Clinical Supplies named Tony Moult general manager of Bilcare GCS Europe; more...

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes