By Ryan Rivers, Shane Mohr, and Lisa DeOerio, Emergent BioSolutions
Mitigating risk is a key consideration for pharmaceutical companies when planning their clinical trial material and/or drug product manufacturing processes. One of the most prevalent sources is material handling: every step in the drug substance or drug product manufacturing process can introduce risk. Biopharmaceutical companies and contract development and manufacturing organizations (CDMOs) collaborate to ensure a number of technologies are utilized to safeguard the integrity of these products. One method is to leverage a Restricted Access Barrier System (RABS) or isolator technology during drug product manufacturing.
This equipment represents an integral component of a manufacturer’s quality control strategy. The current regulatory landscape requires drug manufacturers to employ a RABS or isolator as part of their risk mitigation approach, and each technology possesses pros and cons depending on the parameters and requirements of a project. While each one is robust enough to ensure consistent and reliable production, companies looking to develop in-house capabilities or contract to a CDMO should understand the key elements of both in order to make the best, most informed decision for their product.