Crowe emphasized its commitment to innovation and collaboration as key drivers of success in addressing the evolving needs and challenges of the pharmaceutical sector.
Purolite, acquired by Ecolab in 2021, has been at the forefront of revolutionizing bioprocessing purification with its cutting-edge jetted resin technology. Crowe highlighted the acquisition's strategic rationale, saying, “We were really excited about Purolite’s resin and specifically around this kind of jetted technology it had to produce consistent resins with a very tight control over bead size and distribution and the ability to streamline supply lead times to the market.”
This jetted resin technology enables Purolite to rapidly produce beads with consistent sizes, crucial for the purification of diverse drug molecules. Crowe elaborated on Purolite's commitment to innovation, “We've launched Praesto CH1, an affinity resin designed to purify specialized monoclonal antibodies (mAbs) such as bispecific and recombinant antibody fragments.
The new resin is the result of a long-term strategic partnership between Purolite and Repligen, that enables improved market choice to customers by combining Purolite’s base bead technology with Repligen’s novel ligands.
High selectivity for antibodies
The CH1 resin, an addition to Purolite's protein A resin toolbox, exhibits high selectivity for antibodies with the human CH1 domain. This enables the capture of bispecific antibodies and antibody fragments while eliminating mis-paired species, offering an effective alternative when traditional protein A resins are unsuitable. Praesto CH1 promises enhanced productivity and cost efficiency for the bioprocessing sector.
With continued investment from Ecolab, Purolite's goal is to secure supply. The beads are uniform, meaning unrivaled lot-to-lot consistency and minimal variation batch to batch. One of the most time-consuming steps in agarose resin production is the screening step to filter out beads that are too large or too small to be used in the process. Through jetting technology, Purolite makes this step completely redundant ergo reducing lead times.
There are ISO-accredited Praesto Jetting facilities in Cardiff, UK, that conform to global quality standards, and Crowe says Purolite is leading the way in improving the security of supply of agarose-based resins by commissioning production facilities on multiple continents.
The interview also delved into Purolite's approach to addressing the evolving needs of API formulation development in the pharmaceutical industry, particularly in areas like solubility enhancement and modified release technologies.
Transitioning to oral formulations
She addressed the challenges associated with transitioning to oral formulations, “Our collaborative approach with customers helps navigate these complexities effectively,” she said, underscoring the company's dedication to customer-centric solutions.
Crowe explained the company's collaborative approach with customers, “[Whether it’s bioprocessing purification, or APIs and excipients,] our teams will sit down and work through solutions with the individual companies – everyone has different and unique needs. For us, we have been focused on the resin technology and the purification process.”
She highlighted the importance of partnerships in driving innovation, citing Purolite's successful collaboration with Repligen as an example. “Our partnership with Repligen enabled us to move relatively quickly to develop the best bead and ligand combination,” Crowe added while highlighting the importance of strategic alliances in propelling industry advancements.
Addressing competition in the market, Crowe reiterated Purolite's focus on rapid innovation and strategic partnerships to stay ahead. "For us, it's having the fastest innovation to address the problems and be first to market with those," Crowe stated, underlining the commitment to remaining at the forefront of technological advancements.
Expansion plans for supply chain resilience
The interview also touched upon the company's expansion plans to ensure supply chain resilience. Crowe revealed, “Purolite is expanding its manufacturing capabilities to ensure supply chain resilience, with plans for a new bio-processing resin plant in the US."
In terms of technology and AI, Crowe emphasized Purolite's focus on leveraging data and analytics in downstream bioprocessing. However, Crowe acknowledged existing resistance due to concerns surrounding data privacy and cybersecurity. She highlighted the need for a balanced approach to technological integration. “We are actively exploring how best to leverage Ecolab’s deep digital capabilities and this strategic investment for the benefit of Purolite’s customers.”
Looking ahead, Crowe expressed optimism about prospects, “Our goal is to continue innovating while also securing our supply chain for the future.”
Purolite's solutions and collaborative approach highlight its pivotal role in propelling the biopharmaceutical industry forward. With a focus on rapid innovation, strategic partnerships, and supply chain resilience, Purolite says it will remain at the forefront of revolutionizing bioprocessing technologies.
