Pharmaceutical News & Resources

A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry

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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Posted in: Pharmaceutical Online

Extractables And Leachables Studies Support Single-Use Systems

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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Posted in: Pharmaceutical Online

Nitto Avecia Pharma Services Parenteral Manufacturing

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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Posted in: Pharmaceutical Online

3 Steps To Better Extractables & Leachables Studies

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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Posted in: Outsourced Pharma, Pharmaceutical Online

Nitto Avecia Pharma Services Addresses Questions About Extractables And Leachables Studies

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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Posted in: Pharmaceutical Online

Container/Closure Innovation Delivers New Complexity In Drug Quality

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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Posted in: Pharmaceutical Online

A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry

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...

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Posted in: Pharmaceutical Online

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

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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Posted in: Pharmaceutical Online


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