Quality/GMPs

Articles

Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.

Waters and Genovis to Collaborate on Biopharmaceutical Characterization Workflows

 Washington Editor, jillwechsler7@gmail.com.

FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant. 

FDA Shuts Down Emergent Vaccine Facility

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

Hyalo Technologies Unveils Room Temperature Drug-Stabilizing Technology

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

FDA Inspectors Cited Critical Problems at Emergent Facility

Feliza Mirasol is the science editor for 

Dynamic light scattering presents a good analytical technique for testing protein stability.

Stability Testing of Protein Therapeutics Using DLS

Saroj Ramdas is GSK fellow and director, CMC regulatory strategy and advocacy with GlaxoSmithKline.

Renata Varga is principal scientist, Teva Branded Pharmaceutical Products R&D, Inc.

Martin Gastens is senior director program management, AbbVie Deutschland GmbH & Co. KG.

Twinkle R. Christian is process development scientist at Amgen.

Bharat Jagannathan is process development senior scientist at Amgen.

Barbara Rellahan, rellahan@amgen.com, is director, product quality, at Amgen.

Jillian Brady is manager, science, regulation & policy, Faegre Drinker Biddle & Reath LLP.

Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.

Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies

Ganapathy Mohan*, Ganapathy_mohan@merck.com, is executive director, global quality compliance, Merck & Co., Inc., Kenilworth, NJ, USA.

Christopher Turner is associate director, quality laboratory practices, Bristol Myers Squibb.

Dennis O’Connor is senior associate director, GMP QA, Boehringer Ingelheim.

Lisa Fink is senior quality technical consultant (retired), Baxter Healthcare Corporation.

Thomas Purdue is quality analyst V, Boehringer Ingelheim.

Jeffrey Beebie is director and GLP QA team lead, Pfizer, Inc.

Kerri Robles is director, quality laboratory practices, Bristol Myers Squibb.

Karen Waetjen is director, GCP/GLP Compliance, Amgen.

Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.

Collaborative Efforts Address Key Data Integrity Challenges

A growing pipeline of gene therapy candidates aimed at treating neurodegenerative diseases has prompted new guidance.

Gene Therapies Target Neurodegenerative Diseases

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Auditing distribution suppliers provides understanding and documentation of the services performed. 

Auditing for Good Distribution Practices

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

Quality Control/Quality Assurance