Pharmaceutical News & Resources

Nitto Avecia Pharma Services: API To Clinic Within 4 Months

June 24th, 2019 by aveciapharma

Nitto Avecia Pharma Services, Inc. has a focused vision. We envision each engagement with prospective or long-term clients as an opportunity to deliver innovative ideas that support their mission. Our corporate vision is "Creating Wonders," and we take that to heart with each service we provide, priding...

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Posted in: Outsourced Pharma

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

Nitto Avecia Pharma Services Addresses Questions About Extractables And Leachables Studies

March 20th, 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: Outsourced Pharma

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

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

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

Extractables And Leachables Studies Support Single-Use Systems

February 27th, 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: Outsourced Pharma

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

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


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