Quality Systems

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Articles

While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.

Bio/Pharma Needs Ideas and Incentives to Advance Manufacturing

Melissa Hanna-Brown is external technology & collaborations lead at Pfizer.

Joachim Ermer is head of Analytical Lifecycle Management Chemistry Frankfurt at Sanofi.

Stephanie Katzenbach is senior scientist, New Biological Entities, Analytical R&D at AbbVie.

Andy Rignall is product technical director at AstraZeneca.

Annick Gervais is director, Analytical Sciences Biologicals at UCB.

JÃ¶rg Hoffmann is director, CMC Regulatory Compliance at Merck KGaA.

Kieran McLaughlin is principal scientist at MSD.

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Oliver Grosche is director, Collaborative Solutions at Elanco.

Peter Hamilton is scientific leader at GSK.

Thomas Uhlich is laboratory head Analytical Development at Bayer.

Christof Finkler is Analytics Biochemistry site head at Roche.

Katrin Liebelt is analytical project leader at Novartis.

Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle Management Team.


Three Examples of Hypothetical ATPs

Sharon Ayd is chief scientific officer and SVP, Pharmaceuticals at Regulatory Compliance Associates.

GMP non-compliance can spill over and impact patient access to life-saving medications.

Impact of Non-Compliance on the American Healthcare Consumer

Mario DiPaola is senior scientific director at Charles River Laboratories, Woburn, MA.

This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.

Best Practices in Analytical Method Development and Testing

Marc Brown, PhD, is chief scientific officer and co-founder of MedPharm.

Sarah Pratt is chief operating officer at MedPharm.

Christopher Harrison, is head of Process Development and Manufacture at MedPharm.

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.

QbD Strategies to Secure the Scale-Up of Semi-Solid Topical Formulations

Agnes Shanley is senior editor of Pharmaceutical Technology.

Dissolution testing remains one of the pharmaceutical industry’s most straightforward, least expensive QC tools. Research is focusing on ways to extend its reach, improve in-vitro and in-vivo correlation, and make real-time release testing a reality.

Simple by Design

Ed Trappler is president and founder of Lyophilization Technology, Inc. a contract research and technical services firm dedicated to freeze drying. He has over 40 years of experience in lyophilization that ranges from product development to equipment application engineering. He received his Bachelor of Science degree in chemistry at The College of New Jersey. His experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing and parenteral production.

Denise L. Miller is document control specialist at Lyophilization Technology, Inc.

Carrie A. Shults is associate director at Lyophilization Technology, Inc.

Quality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.

Identifying TPPs and CQAs for a Lyophilized Parenteral Product

Taking vendor product data at face value puts pharmaceutical manufacturers and their supply chain partners at risk.

Certificates of Analysis: Don’t Trust, Verify

Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for
perfusion culture. 

Ambr 250 High Throughput Bioreactor System Speeds Up Intensified Cell Culture Process Development

Bir Gujral is director, global quality analytics, PSG, at Thermo Fisher Scientific 

Twenty-first century drug development challenges sponsors and contract partners to collaborate more closely, using tools such as model-based simulation.

Quality by Design