Category Archives: Pharmaceutical Online

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

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

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

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

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

Container/Closure Innovation Delivers New Complexity In Drug Quality

By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services Why is this service needed? Many new delivery systems and drug-device combinations make dosing less cumbersome for patients and healthcare providers. But they add more complexity for drug developers. Traditionally viewed as isolated subassemblies, container/closure systems today are essential to achieving therapeutic … Continue reading Container/Closure Innovation Delivers New Complexity In Drug Quality

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

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