March 28th, 2019 by Aryo A. Nikopour
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...
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Tags: extractables and leachables, presentations, case studies
Posted in: Pharmaceutical Online
March 12th, 2019 by Aryo A. Nikopour
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...
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Tags: extractables and leachables, case studies
Posted in: Pharmaceutical Online
March 5th, 2019 by aveciapharma
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...
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Tags: FDA, parenteral manufacturing, GMP environment
Posted in: Pharmaceutical Online
February 20th, 2019 by Aryo A. Nikopour
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...
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Tags: extractables and leachables, case studies
Posted in: Outsourced Pharma, Pharmaceutical Online
February 14th, 2019 by Aryo A. Nikopour
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,...
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Tags: presentations, case studies, Xtalks, FDA, parenteral manufacturing
Posted in: Pharmaceutical Online
February 5th, 2019 by Adam C. Fox
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....
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Tags: FDA, compliance and guidelines, regulations, international
Posted in: Pharmaceutical Online
January 22nd, 2019 by Aryo A. Nikopour
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...
Read Full Story »
Tags: extractables and leachables, presentations, case studies
Posted in: Pharmaceutical Online
January 17th, 2019 by aveciapharma
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...
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Tags: presentations, GMP environment, cell-based assays
Posted in: Pharmaceutical Online