How do we secure your Protein A resin supply chain? (360° Video)

Eliminate security of supply risk in mAb production by implementing a dual-sourcing strategy

Protein A affinity chromatography continues to be the preferred method of choice for the purification of antibodies, due to its very high selectivity and robust resin performance over repeated purification cycles.

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.


Purolite Life Sciences Praesto® AP is a biosimilar to MabSelect SuRe LX* and Praesto® APc is a biosimilar to MabSelect SuRe*.  Both use the same ligand but vary in ligand density.  Feedback from internal and customer evaluations by end-users suggests this holds true across multiple antibodies.

A comprehensive evaluation by Pabst et al of MedImmune published in the Journal of Chromatography A (1) provides similar conclusions.  Praesto® PrA resins are currently in PII clinical trials and expect to move to PIII before the end of 2019.

When Purolite Life Sciences asked you for your key concern with bringing mAbs to market we heard a loud and clear…”secure our supply”; so we answered your call.

Today, Purolite has one of the world’s largest agarose resin manufacturing facilities - producing a range of high flow agarose Protein A chromatography resins specifically designed to give purification performance equal to, or better than, today’s 
market leading agarose resins.

Why Purolite?

  • Opened one of the world’s largest agarose manufacturing facilities in 2018, with a capacity of 100,000L - 30% of today’s global demand;
  • Trusted for over 35 years;
  • 100% focused on resin innovation, with the widest portfolio of resins;
  • Over 25 years’ regulatory experience;
  • A family of specialists, scientists, and customer service professionals dedicated to meeting and understanding our customers’ needs with speed, professionalism, and the highest degree of knowledge.


 

 

Ensuring reliable availability of our resins is vital to customers, and of paramount importance to Purolite.  As a leading supplier of resin media to the world’s most regulated industries, we recognise that Praesto® resins are critical purification products.  As such Purolite has a real-world security-of-supply system in place, to support your process requirements for business continuity.

Purolite
take a risk-based approach to supply management and all agarose related activities occur at our centralised ISO 9001:2015 manufacturing facility in Llantrisant Wales, UK.  This includes R&D, manufacturing, customer applications, quality and regulatory affairs together with commercial operations.  With a total capacity of 100,000L – 30% of today’s global demand – it is one of the world’s largest agarose resin manufacturing facilities.  It produces a range of high flow agarose Protein A chromatography resins, specifically designed to demonstrate technology leadership in the area of agarose resins.  

Supply risk is managed end-to-end, and alternate sources of key raw materials have been identified.  Purolite uses a global network of qualified suppliers and has long-term supply agreements with periodic audits, to ensure consistency and ‘fit for purpose’ performance.

Duncan Low, an independent consultant from Claymore Biopharm LLC, visited Purolite’s facilities at the end of 2018 with the purpose to provide Purolite with an assessment of their competitive standing as a potential supplier of agarose resins, and to provide Purolite with insight into the expectations biopharmaceutical manufacturers have for their suppliers. Six areas were assessed, corporate structure, development history, manufacturing technology, quality systems, technical and regulatory, security of supply.  His conclusions were:

“Purolite
are a viable and desirable alternative for the purification of biopharmaceuticals in terms of technology, quality, and by no means least, economy.  They have supporting capabilities for supply and risk reduction.  I would strongly encourage their potential customers to give them their full consideration.  There is no technical reason for not doing so, and there are compelling strategic and financial reasons that support an evaluation.  Failure to do so will not change the current market dynamics."

Duncan Low retired from Amgen as a Scientific Executive Director in 2017. He was responsible for forming a Materials Science team, specializing in raw materials, and led a cross-functional Raw Materials Global Network  This was highly effective in establishing supplier technical relationships, reducing material related non-conformances, and in preparing Amgen for a forward-looking materials sourcing strategy aligned with their innovative manufacturing strategy.

Prior to joining Amgen he held VP positions at Millipore and Pharmacia Biotech and was instrumental in developing their process chromatography capabilities. He has an M.A. in Biochemistry from the University of Cambridge and a
Ph.D. in Microbiology from the University of Glasgow.

Talk to us to discuss how we can work with you to implement a dual-sourcing strategy, boost your security of supply and

  • Greatly reduce supply risk
  • Cut lead times
  • Manage your supplier base
  • Reduce your costs

To find out more about Purolite Life Sciences and how we can assist you in meeting and understanding your needs, contact us directly at lifesciences@purolite.com