July 13th, 2020 by aveciapharma
Pharmaceuticals are undoubtedly an extremely R&D intensive when compared to most other industries. As the process of producing new drugs is not only a time-consuming and costly endeavor but also has deadlines to meet. That’s why when presented with these challenges, pharmaceutical companies seek...
Posted in: Services
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...
Posted in: Outsourced Pharma
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...
Posted in: Pharmaceutical Online
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,...
Posted in: Outsourced Pharma
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...
Posted in: BioProcess Online, Outsourced Pharma
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...
Posted in: Pharmaceutical Online
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...
Posted in: Pharmaceutical Online
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,...
Posted in: BioProcess Online
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...
Posted in: Outsourced Pharma
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,...
Posted in: BioProcess Online