Pharmaceutical News & Resources

Elemental Impurities Emerge As New Compliance Challenge

March 13th, 2019 by Adam C. Fox

By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services Why is this service needed? After almost 20 years of discussion, the FDA issued new guidelines in 2018 for controlling and measuring the risk of contamination within pharmaceutical products due to the presence...

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Posted in: BioProcess Online, Outsourced Pharma

Why Cell-based Assay Is The Preferred Method To Support Potency Analysis For Biologics

March 4th, 2019 by Aryo A. Nikopour

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 Unlike small molecule therapeutics, which are chemically synthesized, stable,...

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Posted in: BioProcess 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

Residual Solvents Testing

February 4th, 2019 by aveciapharma

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...

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Posted in: BioProcess Online

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

January 16th, 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 important...

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Posted in: BioProcess Online, Outsourced Pharma

Stability Testing

January 9th, 2019 by aveciapharma

With over 14,000 ft2 storage capacity and over 14 ICH and custom conditions, Nitto Avecia Pharma Services has the capability to help design stability studies tailored to product needs. For the quality control and security your projects demand, all cGMP validated environmental and photostability...

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Posted in: BioProcess Online

XTALKS PRESS RELEASE FOR Nitto Avecia Pharma (April 17/18 Webinar)

April 17th, 2018 by aveciapharma

HEADLINE Cell-Based Assays in a CGMP Environment: Approaches for Clinical and Commercial Stability Studies, New Webinar Hosted by Xtalks. SUB-HEADLINE Presentation to highlight the approaches used in developing consistent cell-based potency assays meeting regulatory expectations (USP and ) and...

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Posted in: Press Release


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