Category Archives: Outsourced Pharma

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

3 Steps To Better Extractables & Leachables Studies

By Aryo A. Nikopour, Nitto Avecia Pharma Services There is no shortage of guidance for conducting extractables and leachables studies. For instance, U.S. Pharmacopeia and the Product Quality Research Institute (PQRI) offer separate and useful recommendations. However, an ideal approach is to combine guidance from both organizations, says Aryo A. Nikopour, Senior Vice President of … Continue reading 3 Steps To Better Extractables & Leachables Studies

Residual Solvents Add Risk To Drug Safety

By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services Why is this service needed? Improper detection and removal of residual solvents in raw materials and drug products can cause significant risks to quality and safety. In many cases, solvents used to maximize production yields are difficult to eliminate. Too often, residual … Continue reading Residual Solvents Add Risk To Drug Safety

Cell-Based Assays In A GMP Environment: Approaches For Clinical And Commercial Stability Studies

By Ming Li, Ph.D., Principle Scientist & Team Lead, Biopharmaceutical Developmental and Aryo A. Nikopour, SVP of Scientific & Technical Services Dr. Ming Li, Principle Scientist and Team Lead in the Biopharmaceutical Developmental department at Nitto Avecia Pharma Services, discusses some basics of cell-based assay and why it’s the preferred method to support potency analysis … Continue reading Cell-Based Assays In A GMP Environment: Approaches For Clinical And Commercial Stability Studies

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