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

Also, Alpharma advises shareholders to reject King's offer; ImClone rejects raised BMS offer; Immunogen appoints Daniel M. Junius, more...

Company and People Notes: GSK to Cut up to 850 Jobs; Zerhouni to Leave NIH; More...

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

The growth and globalization of the pharmaceutical supply chain make risk assessment more important than ever for pharmaceutical manufacturers. The authors describe a program to identify, prioritize, mitigate, and communicate risks in manufacturer–supplier relationships.

Risk Management within the Global Supply Chain

The biggest benefit of PAT and the current FDA initiatives may be in allowing pharmaceutical scientists to use their technical capabilities to improve pharmaceutical processes.

PAT — a team effort

Also, Zentiva accepts Sanofi's increased takeover bid, Oriel Therapeutics appoints Richard Fuller CEO, more...

Company and People Notes: Committee on Energy and Commerce Expands Ranbaxy Probe; Eli Lilly Appoints John C. Lechleiter Chairman of the Board; More...

Also, Quintiles to expand Singapore operations; Christine A. Poon, chairman of Johnson & Johnson's pharmaceuticals group, to retire; more...

Company and People Notes: King Commences Tender Offer for Alpharma; Genentech Appoints Morgan Sheng VP of Neuroscience; More...

Also, Human Genome Sciences enters pact with Hospira, Zosano Pharma names Gail Schulze chair and CEO, more...

Company and People Notes: FTC Asks Teva and Barr For Additional Information, GSK's Chris Viehbacher to Leave Company, More...

USP announced an interim revision to its monograph for levothyroxine sodium tablets, which will become official in USP 32-NF 27.

USP Revises Potency Spec for Levothyroxine Sodium Tablets

Also, Novartis stops development on "Aurograb," Zealand Pharma appoints David H. Solomon as CEO, more...

Company and People Notes: GSK and Valeant Collaborate on Investigational Drug, Aptuit Appoints Timothy C. Tyson Executive Chairman and Acting CEO, More...

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The US Food and Drug Administration will hold a public meeting this month to gain public input on implementing the recommendations of the Nanotechnology Task Force report, taking another step closer to setting a regulatory framework for nanotechnology for pharmaceuticals and medical devices.

Setting a Regulatory Framework for Nanotechnology

Jennifer Medlar is a consultant for Advanced Biomedical Consulting, LLC

Nancy Cafmeyer is a project manager for Advanced Biomedical Consulting, LLC.

Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes