Category Archives: BioProcess Online

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

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

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

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

How To Design Cell-based Potency Assays

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 Cell-based potency assays use live cells to mimic biological reactions in the body, providing both quantitative and relevant responses. They are generally preferred by regulatory … Continue reading How To Design Cell-based Potency Assays

Residual Solvents Testing

Assure compliance now with Nitto Avecia Pharma Services’ cost effective identification and quantification of impurities. Nitto Avecia Pharma Services provides expert, rapid analysis of all three classes of residual solvents. Our USP/ICH compliant, state-of-the-art laboratory, and experienced team of scientists allow you to manage the large number of methods that may be involved in identification … Continue reading Residual Solvents Testing

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