Monthly Archives: January 2019

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

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

Cell-Based Assays in a GMP Environment: Approaches for Clinical and Commercial Stability Studies

Potency of biotherapeutics, often determined by cell-based assays, is one of the most important critical quality attributes. Potency must be monitored throughout the entire drug development cycle as it measures drug activity and provides a direct link to clinical efficacy. An ideal potency assay should represent a drug’s mechanism of action (MOA), as well as be specific and sensitive enough to detect changes and … 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

Microbiological Data

Precision in microbiological data is critical. Nitto Avecia Pharma Services offers extensive testing services via our highly experienced microbiology team. Avecia offers a broad range of compliant, high quality microbiological services. Tests are performed according to official compendial, or industry recognized, and client-provided methodologies. Learn more about how Avecia can help.

Nitto Denko Avecia, Inc. Acquires the Businesses of Irvine Pharmaceutical Services & Avrio Biopharmaceuticals

MILFORD, MA – Nitto Denko Avecia, Inc. (Avecia), today announced it has entered into a definitive agreement to acquire the assets of Irvine Pharmaceutical Services (Irvine) and Avrio Biopharmaceuticals (Avrio), both located in Irvine, CA. Irvine is a leading analytical development services provider and Avrio is a premier cGMP parenteral contract manufacturing organization. Avecia will … Continue reading Nitto Denko Avecia, Inc. Acquires the Businesses of Irvine Pharmaceutical Services & Avrio Biopharmaceuticals