Monthly Archives: March 2019

A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry

By Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services, Nitto Avecia Pharma Services Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services with Nitto Avecia Pharma Services, discusses the basic definitions of extractables and leachables and why it is important to reference the vast amount of reference material available to … Continue reading A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry

How To Transfer Cell-based Potency Assays Into A GMP Environment And Maintain Performance

By Aryo Nikopour, Senior Vice President, Scientific & Technical Services, Nitto Avecia Pharma Services and Ming Li, Ph.D., Principle Scientist and Team Lead in Biopharmaceutical Development, Nitto Avecia Pharma Services Like all living things, cells are sensitive to change. Cell-based assays, due to their high variability, are probably the hardest methods to transfer between labs. … Continue reading How To Transfer Cell-based Potency Assays Into A GMP Environment And Maintain Performance

Nitto Avecia Pharma Services Addresses Questions About Extractables And Leachables Studies

By Aryo A. Nikopour, Nitto Avecia Pharma Services Extractable and leachable safety assessments can be some of the most challenging review issues in an FDA application, according to an agency official.1 That is because they require a coordinated effort between review staff from Chemistry, Manufacturing, and Controls and Toxicology. FDA’s Dan Mellon, a toxicology supervisor with … Continue reading Nitto Avecia Pharma Services Addresses Questions About Extractables And Leachables Studies

Elemental Impurities Emerge As New Compliance Challenge

By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services Why is this service needed? After almost 20 years of discussion, the FDA issued new guidelines in 2018 for controlling and measuring the risk of contamination within pharmaceutical products due to the presence of heavy metals. The agency issued guidance in August … Continue reading Elemental Impurities Emerge As New Compliance Challenge

Extractables And Leachables Studies Support Single-Use Systems

By Aryo Nikopour, Senior Vice President, Scientific & Technical Services, Nitto Avecia Pharma Services Single-use systems have gained a surprisingly strong foothold in the drug manufacturing market thanks to improved extractables and leachables studies. Not long ago, concerns about leachables were expected to restrict adoption of single-use systems. 2015 Survey Found Limited Interest in Disposable … Continue reading Extractables And Leachables Studies Support Single-Use Systems

Nitto Avecia Pharma Services Parenteral Manufacturing

Nitto Avecia Pharma Services is a FDA inspected cGMP contract development and manufacturing organization supporting the pharmaceutical and biopharmaceutical industries from early phase through post-market life cycle management. With a state-of-the-art facility, experienced staff, and robust quality infrastructure, Avecia Pharma delivers client-centric solutions in a timely manner. Nitto Avecia Pharma Services has a state-of-the-art facility … Continue reading Nitto Avecia Pharma Services Parenteral Manufacturing

Why Cell-based Assay Is The Preferred Method To Support Potency Analysis For Biologics

By Aryo Nikopour, Senior Vice President, Scientific & Technical Services, Nitto Avecia Pharma Services and Ming Li, Ph.D., Principle Scientist and Team Lead in Biopharmaceutical Development, Nitto Avecia Pharma Services Unlike small molecule therapeutics, which are chemically synthesized, stable, and easily characterized, the biotherapeutics must be produced in in a living cell and present a … Continue reading Why Cell-based Assay Is The Preferred Method To Support Potency Analysis For Biologics