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 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 5th, 2019 by Adam C. Fox
By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services Why is this service needed? Many new delivery systems and drug-device combinations make dosing less cumbersome for patients and healthcare providers. But they add more complexity for drug developers....
Posted in: Pharmaceutical Online
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...
Posted in: BioProcess Online
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...
Posted in: BioProcess Online, Outsourced Pharma
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...
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...
Posted in: Press Release