BIA Webinar - Risk management mitigation via a dual sourcing approach
In partnership with Purolite and eXmoor Pharma
Hans J Johansson
Hans has over 30 years of experience in the biotech business, having spent 25 years with Pharmacia/Amersham/GE Healthcare.
He holds more than ten patents in the area of resin design and large-scale protein purification. Hans leads the Applications group in Purolite Life Sciences - Agarose
An increasing trend by biopharmaceutical developers is to build a robust supply chain for all key critical components as part of their own business continuity plans. The development of antibody-based therapies is currently the most important activity in the industry. Although most critical materials used in manufacturing can be sourced from different vendors, chromatography resins typically are not. This is because, in many cases, no second-source alternatives are available. When it comes to protein A resins, only one vendor has the capacity to supply agarose-based resins in volumes required by the industry. This Security of Supply risk is a major concern.
Now, with the introduction of Purolite’s new Protein A resins, the industry has the option to dual source to manage risk, reduce dependency and manage cost to increase affordability and availability of these key treatments.
During the webinar we will present a case study that looks at the purification performance of different base matrices and protein A ligands to support the concept of dual sourcing.
Dr David Vincent
David has 10 years experience in downstream process development and technology transfer. He provides technical expertise in mAb and viral vector processes and has worked with a wide variety of unit operations and analytical techniques using both univariate and a range of multivariate tools, including DoE, and Simplex to solve complex problems. David joined eXmoor Pharma Concepts in June 2017 and currently works as a Bioprocess Engineer in their comercialiastion laboratory.
The Cell and Gene Therapy field has gained traction in recent years, giving patients increased access to curative treatments. The global supply chain of critical raw materials required for the manufacture of cells, viral vectors and plasmid DNA is maturing, however, there are numerous examples where organisations are reliant on single vendor sourcing for equipment, components and reagents.
Addressing this risk will increasingly require improved scientific and engineering knowledge of products and processes, broader supply chains, and an understanding of the regulatory framework to facilitate dual sourcing where appropriate.
This webinar will discuss some of the production challenges that may face the Cell and Gene Therapy industry as an increasing number of products are scaled up and out.