In Part 1 of ‘Manufactured by Jetting - The Future in Protein A Affinity Matrix Design’, we identified the most important factors to consider during the evaluation of Protein A resins, including dynamic binding capacity, process economics and functional lifetime.
In Part 2, we discuss security of supply in mAb production, and managing risk by implementing a dual-sourcing strategy. We also look at Purolite's patented ‘jetting’ process, and how it is being combined with a new alkaline-stable Protein A resin.
Security of Supply and Risk Management:
Commercial processes could be operated for more than 20 years. It is therefore important to evaluate the financial stability of a vendor and ensure procedures are established for disaster recovery and product discontinuation. Production capacity and lead time are also key considerations when selecting a vendor to ensure a consistent, stable supply of adequate volumes of resin.
With the continued growth and therapeutic commercial importance of mAb production, the availability of high-quality agarose resins is critical. Furthermore, as the current commercial patents for therapeutic antibodies expire, the cost of manufacturing will be of increasing interest. Approximately 90% of all biopharmaceuticals approved by the U.S. Food and Drug Administration utilise a single source of agarose resins from a single manufacturing site, presenting a security of supply risk to long-term clinical trial material production.
Currently, only one vendor on the market has the capacity to supply agarose-based resins in the volumes required by the industry. Therefore, the ‘security of supply’ of Protein A affinity resins is a major concern. This was until Purolite Life Sciences developed its range of batch emulsified Praesto® resins. The goal being to design resins to deliver the same performance as the market leading resins, and ultimately enable dual sourcing.