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
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...
Posted in: Outsourced Pharma, Pharmaceutical Online
February 14th, 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: Pharmaceutical Online
February 13th, 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 Cell-based potency assays use live cells to mimic biological reactions in the...
Posted in: BioProcess Online
February 6th, 2019 by Adam C. Fox
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...
Posted in: Outsourced Pharma
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 30th, 2019 by aveciapharma
Click here to download Nitto Avecia Pharma Services Corporate Overview brochure....
Posted in: Outsourced Pharma
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...
Posted in: Outsourced Pharma
January 22nd, 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...
Posted in: Pharmaceutical Online
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...
Posted in: Pharmaceutical 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