Case Study

Model Extraction Studies Examined For Monoclonal Antibody In Prefilled Syringe (PFS)

Source: Nitto Avecia Pharma Services

By Aryo A. Nikopour is Senior Vice President of Scientific and Technical Services, Nitto Avecia Pharma Services

Model Extraction Studies Examined For Monoclonal Antibody In Prefilled Syringe (PFS)

It’s been more than 30 years since monoclonal antibodies were first licensed for clinical use.1

But product developers are still inventing novel ways to improve their safety and efficacy.

FDA approved Orthoclone OKT3 (muromonab-CD3) in 1986 for preventing kidney transplant rejection. As of March 2017, FDA has approved approximately 60 therapeutic monoclonal antibodies (MAbs), and many more are under evaluation in various phases of clinical trials.2

Supporting one of these MAbs, Nitto Avecia Pharma Services developed model extraction studies to evaluate the suitability of a glass prefilled syringe (PFS) for its intended use. The studies were designed to systematically examine the entire PFS assembly when exposed to a formulation buffer.

Monoclonal antibodies are nothing new. But product developers like Nitto Avecia Pharma Services are still inventing novel ways to improve them.