Quality/GMPs

Jaap Venema, PhD, is Executive Vice President and Chief Science at US Pharmacopeia (USP).

Jennifer Devine, JD, is Senior Vice President, Documentary Standards and Compendial Policy at US Pharmacopeia (USP).

Articles

Public health challenges have highlighted the need for agility in maintaining the quality of medicines. 

Public Trust in Medicine Quality as Public Health Challenges Emerge

Feliza Mirasol is the science editor for 

Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.

Bioanalytical Studies Support Biosimilars Approval Pathway

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

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

The Basics of Aseptic Processing

GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.

FDA Removes Clinical Hold on Phase I/II Study of Angelman Syndrome Treatment

Garrett Perry is a technical services specialist at Teknova, www.teknova.com.

As interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases. 

How Pure is Pure? Understanding Reagent Purity Grades

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

BioPharm International asked Vincent Colicchio, vice president, supply chain and external manufacturing at Dr. Reddy’s Laboratories, about how a lack of proper supplier oversight can impact the pharmaceutical industry and the drug supply chain.

The Impact of Insufficient Oversight

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

Siegfried Schmitt, vice president, Technical at Parexel, provides best practices for switching from paper-based to automated processes.

Improve Automation, but Beware of the Pitfalls

Thomas A. Little, PhD, is president, Thomas A. Little Consulting and BioAssay Sciences, 12401 North Wildflower Lane, Highland, Utah 84003, USA, drlittle@dr-tom.com.

Correct organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.

Statistical Approaches for Determining Comparability of Biosimilars

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

FDA Gives Green Light to Emergent BioSolutions to Resume COVID-19 Vaccine Manufacturing

 Washington Editor, jillwechsler7@gmail.com.

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

Quality Control/Quality Assurance