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

Nitto Avecia Pharma Services Addresses Questions About Extractables And Leachables Studies

March 20th, 2019 by aveciapharma

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 aveciapharma

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

February 27th, 2019 by aveciapharma

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

3 Steps To Better Extractables & Leachables Studies

February 20th, 2019 by aveciapharma

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

Residual Solvents Add Risk To Drug Safety

February 6th, 2019 by aveciapharma

By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services Why is this service needed? Improper detection and removal of residual solvents in raw materials and drug products can cause significant risks to quality and safety. In many cases, solvents used to...

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Posted in: Outsourced Pharma

Nitto Avecia Pharma Services Corporate Overview

January 30th, 2019 by aveciapharma

Click here to download Nitto Avecia Pharma Services Corporate Overview brochure....

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Posted in: Outsourced Pharma

Cell-Based Assays In A GMP Environment: Approaches For Clinical And Commercial Stability Studies

January 23rd, 2019 by aveciapharma

By Ming Li, Ph.D., Principle Scientist & Team Lead, Biopharmaceutical Developmental and Aryo A. Nikopour, SVP of Scientific & Technical Services Dr. Ming Li, Principle Scientist and Team Lead in the Biopharmaceutical Developmental department at Nitto Avecia Pharma Services, discusses some basics of...

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Posted in: Outsourced Pharma

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

January 16th, 2019 by aveciapharma

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


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