Monthly Archives: February 2019

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

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

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

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

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 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

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

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