Quality/GMPs

Feliza Mirasol is the science editor for 

Articles

Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.

Setting Up Bioprocessing Systems for Digital Transformation

Catherine Liloia, Catherine.Liloia@ppd.com, is director at PPD Laboratories’ GMP cell lab.

Benjamin Ziehr, PhD, is senior group leader at PPD Laboratories’ GMP cell lab.

Derrick McVicker, PhD, is group leader at PPD Laboratories’ GMP cell lab.

Yat Yee Wong, PhD, is group leader at PPD Laboratories’ GMP cell lab.

Esteban Carrillo, PhD, is senior research scientist at PPD Laboratories’ GMP cell lab.

Alexander Rodriguez, PhD, is research scientist at PPD Laboratories’ GMP cell lab.

The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.

Development Strategies for Cell and Gene Therapy Methods

ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.

ISPE Releases New Knowledge Management Guide 

Laurent Lafferrère, PhD, is chief operating officer at PathoQuest.

Audrey Brussel, PhD, audrey.brussel@pathoquest.com, is Viral Safety leader at PathoQuest.

Assessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.

Challenges When Outsourcing Viral Safety Services

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

The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.

Ensuring Contract Manufacturing Facilities Are Up to Speed

Andrea Sardella, PhD, is pharma inspection product development manager for Stevanato Group, 

A best practices approach to pharma’s most challenging-to-inspect container. 

The Ins and Outs of Syringe Inspection

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

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.

Computerized System Descriptions–How Hard Can It Be?

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.

Quality Control/Quality Assurance