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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Tags: FDA, parenteral manufacturing, GMP environment
Posted in: Pharmaceutical Online
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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Tags: GMP environment, cell-based assays
Posted in: BioProcess Online
January 23rd, 2019 by Ming Li, Ph.D.
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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Tags: presentations, case studies, GMP environment, cell-based assays
Posted in: Outsourced Pharma
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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Tags: presentations, GMP environment, cell-based assays
Posted in: Pharmaceutical Online
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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Tags: case studies, compliance and guidelines, GMP environment, quality and safety
Posted in: BioProcess Online
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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Tags: presentations, Xtalks, compliance and guidelines, GMP environment, cell-based assays, regulations
Posted in: Press Release
January 15th, 2018 by aveciapharma
NITTO AVECIA PHARMA SERVICES APPOINTS RAYMOND KACZMAREK AS PRESIDENT
IRVINE, CA – Nitto Avecia Pharma Services, Inc. (Avecia Pharma), a leading CGMP contract development and manufacturing organization (CDMO), announced today that it has appointed Raymond Kaczmarek to the position of President....
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Tags: GMP environment, announcements
Posted in: Company News, Press Release
October 11th, 2016 by aveciapharma
MILFORD, MA – Nitto Denko Avecia, Inc. (Avecia), today announced it has entered into a definitive agreement to acquire the assets of Irvine Pharmaceutical Services (Irvine) and Avrio Biopharmaceuticals (Avrio), both located in Irvine, CA. Irvine is a leading analytical development services...
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Tags: GMP environment, announcements, oligonucleotide
Posted in: Company News, Press Release