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

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Articles

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...

Company and People Notes: King Announces Restructuring; SCOLR Pharma Appoints President and CEO; More...

Angie Drakulich was editorial director of Pharmaceutical Technology.

The United States Pharmacopeial (USP) Convention is pursuing greater collaboration with the US Department of Health and Human Services (HHS), and specifically, the US Food and Drug Administration.

USP Offers HHS Advice and Assistance

Also, recalls for two KV Pharmaceutical subsidiaries; Human Genome Sciences delivers anthrax drug to US Strategic National Stockpile; Akorn president and CEO leaves the company; more...

Company and People Notes: AstraZeneca Announces More Job Cuts; Deirdre Connelly Leaves Eli Lilly for GSK; More...

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The Federal Trade Commission has filed a complaint in federal district court challenging agreements in which Solvay Pharmaceuticals (Marietta, GA) paid generic drug makers Watson Pharmaceuticals (Corona, CA) and Par Pharmaceutical Companies (Woodcliff Lake, NJ) to delay generic competition to Solvay's branded testosterone-replacement drug "AndroGel," a prescription pharmaceutical with annual sales of more than $400 million, according to an FTC press release.

FTC Files Complaint Against Generic Drug Makers

The US Pharmacopeial (USP) Convention has announced new standards for heparin and glycerin.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes