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

How To Transfer Cell-based Potency Assays Into A GMP Environment And Maintain Performance

February 25th, 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 Like all living things, cells are sensitive to change. Cell-based assays,...

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Posted in: BioProcess Online

How To Design Cell-based Potency Assays

February 13th, 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 Cell-based potency assays use live cells to mimic biological reactions in the...

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Posted in: BioProcess 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


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