Quality/GMPs

Feliza Mirasol is the science editor for 

Articles

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.

Complex Biomolecules Require Analytical Evolution

Thomas Cullen works in analytical research and development at AbbVie Inc. (North Chicago, IL).

Cliff Mitchell works in Analytical Research and Development at AbbVie Inc. (North Chicago, IL).

Julie Lippke works in analytical research and development at Pfizer Inc. (Groton, CT).

Joseph Mongillo works in analytical research and development at Pfizer

Koottala S. Ramaswamy works in Global Development Quality at Merck & Co., Inc. (West Point, PA).

Thomas Purdue is quality analyst V, Boehringer Ingelheim.

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing

New biologic modalities, such as cell and gene therapies, pose increasing difficulties in viral clearance testing methods.

Viral Clearance Testing Increasingly Challenged by New Biologic Modalities

Anne Marie Dixon-Heathman, annemarie@cleanroommanagement.com, is principal of Cleanroom Management Associates, Inc.

Help prevent contamination in a facility by zone.

360 Degrees of Cleanliness

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

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

The Value of FDA 483s and Warning Letters

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.

Quality Control/Quality Assurance