Analytical Development & Testing Experience Critical To Making Outsourcing Decisions – A CDMO Perspective

According to a survey conducted by contract pharma, approximately 9 in 10 (90.4%) companies outsource at least some specialized analytical activity[2]. Routinely outsourced work for biologics include standalone method development, method development of protein/ process-related impurities, release testing, stability testing, characterization studies, compendial testing, bioassay development among many others. Analytical outsourcing market will be worth USD 10.4 Bn by 2026 – expanding rapidly at a rate of 8.1% YoY [1].

Therapeutics derived from biological systems require extensive analytical development and testing. Good analytical capabilities certainly help provide for improved processes (resulting in lower costs), real-time quality control data, consistent product quality, batch to batch comparability, etc in manufacturing [2]. Therefore, CDMOs with good analytical development and testing capabilities brilliantly supplement or even help strengthen manufacturing capabilities. Even during the lifecycle of a product, there are several reasons why companies need to make changes to existing analytical methods – improve method performance (sensitivity, specificity, accuracy or reproducibility), shorten testing timelines, increase operational robustness, etc [3].

Drug regulatory agencies require that biologics such as mammalian cell-culture protein therapeutics – monoclonal antibody, bi-specifics, fusion proteins, etc – need to have CMC analytical regulatory compliance [4]. Regulatory understanding & previous experiences of the CDMO is required not only to appropriately plan & conduct the development activities but also to timely ready regulatory documentation.

CDMO analytical capabilities should surely be a barometer of preference for outsourcing not only analytical work but also manufacturing or process development work. There are many highly sensitive and specific technologies which are becoming common now in biologics analysis and good CDMOs routinely upgrade their capabilities [4].

1. Pharmaceuticals Analytical Testing Outsourcing Market Worth $10.4 Billion By 2026, Grand View Research, Inc., April 2019, https://www.grandviewresearch.com/press-release/global-pharmaceutical-analytical-testing-outsourcing-market
2. Langer, Eric (2017); Current Trends in Analytical Testing (Contract pharma, issue –May 01, 2017)
3.N. Ritter, R. Russel, T. Schionfield, L. Graham, P.Dillon,F. Maggio, L.Bhattacharya, D. Schmalzing, W,Zhou, K. Miller , H. Yang; Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations (BioProcess International Feb 4, 2016)
4Petrie, Glenn, “Evolving CMC Analytical Techniques for Biopharmaceuticals”, ADC review, October 21, 2016