As the demand for resins rises in the bioproduction space, BioProcess Insider spoke to Hans Johansson, global applications director at Purolite to find out the challenges they face and what they are doing to overcome them.
BioProcess Insider (BI): Let’s get right back to basics. What are bioprocess resins and how are they made?
Hans Johansson (HJ): Depending on the molecule requiring purification, chromatography resins are typically leveraged to optimize purity and yield. Chromatography in bioprocessing aims to accomplish three things: capture to isolate, concentrate, and stabilize the molecule.
To start, specific capture of molecules with Protein A affinity chromatography achieves high purity in a single step, this is followed by polishing steps, usually with ion exchange chromatography to achieve final high-level purity by removing aggregates, HCP, and residual DNA. Chromatography resins are generally selected and tested during method and process development to assess the best resin for the job.
BI: what are the latest trends in bioprocess resins?
HJ: Growth in the demand for biopharmaceuticals globally has been a significant driver of growth in the resins segment. More drug developers than ever are seeking high-performance cost-effective resin technologies to help process protein-based pharmaceuticals and bring them to market faster and more efficiently. As a result, the international resins market is expected to grow from $6.73 billion in 2020 to $9.49 billion in 2025, at a CAGR of 7.7%.
BI: What is driving this demand?
HJ: This growth in the specialty resins segment over the last 12 months has been driven by a number of factors and has required innovation on the part of resin suppliers to meet changing biopharmaceutical demand.
One major driver has been the unprecedented global response to the COVID-19 pandemic. This gargantuan effort to vaccinate the global population has seen a sustained spike in demand for high-quality resins to tackle a range of challenges, from creating active pharmaceutical ingredients (APIs), to purifying virus material for vaccines, to acting as excipients in drug formulations.
BI: What would you say the biggest challenge the industry faces is?
HJ: Supply chain resilience is more important than ever for biopharma manufacturing. As a result, manufacturers are continually seeking ways to protect their supply chains against ongoing uncertainties, and other geopolitical shifts.
BI: How do you look to overcome this?
HJ: A key strategy that larger manufacturers are employing is to source a second supply of critical raw materials (such as bioprocess resins), as well as ensure those suppliers either have both domestic manufacturing and international manufacturing capabilities. This helps ensure supply chain risk is mitigated as much as possible. From a supply chain risk perspective Purolite is the only manufacturer to have two different manufacturing sites in two different continents, providing a more secure robust global distribution and assured business continuity in the face of uncertainty.
BI: How is Purolite tackling the demand for higher capacity?
HJ: To address continuing demand for higher capacity Protein A resins, Purolite Praesto products have increased in dynamic binding capacity by an average of 17.5% per year since 2015. These both utilize proprietary manufacturing technology from Purolite not found anywhere else in the agarose bioprocessing resin market to address key challenges and give unique performance benefits vs. competing technologies.
BI: How are you staying ahead of the game with supply chain challenges?
HJ: Purolite has always invested in its facilities, processes, and equipment to ensure that facilities, products, and services are unaffected by disasters, emergencies, and other crisis. Supply risk is managed end-to-end, enabled through a global network of qualified suppliers with long-term supply agreements, periodic audits, and similar measures to ensure consistency and performance.
The company is expanding its manufacturing capacity into the US to address increasing global demand for Protein A resins. The new agarose manufacturing facility will be equipped with Puroliteâ€™s advanced jetting technology.
BI: Can you describe this technology and its advantages?
HJ: [It is] a patented, continuous manufacturing process for producing uniform chromatographic resin beads. We have transformed the resin manufacturing process with our proprietary jetting technology which shortens lead times and also significantly reduces environmental impact, through reduced water consumption, solvent consumption, and CO2 generation. This is a more sustainable alternative to traditional bioprocessing techniques and provides a uniform particle size for a more consistent chromatographic process that boosts mAbs manufacturing efficiency.