Discussing Downstream Bioprocessing Innovations that are Enhancing Manufacturing Efficiencies (BIO 2024)

Ecolab’s acquisition of Purolite in 2021 deepened Ecolab’s support for the bio/pharmaceutical manufacturing process. Post acquisition, Ecolab has focused on developing innovations to support large-scale biomanufacturing, a large, growing market with an estimated $5 billion global fluid separation and purification market size (1), growing at double-digits in biopharma applications, due, in large part, to burgeoning opportunities in the messenger RNA (mRNA), vaccine, and antibody therapeutic sectors. For Ecolab, this growth represents recurring revenue of nearly $0.4 billion in high-end ion exchange resins with “approximately 95% consumable revenue products for purification solutions critical to customer operations. Highly recurring business model as it is usually part of FDA drug filings in life sciences” (1). Puralite adds to this with its unique jetted agarose resin beads with tight size specifications, affinity Protein A resins generally, and its new DurA Cycle product, in partnership with Repligen. The announcement of DurA Cycle follows news of the launch of a previous resin for the purification of complex bispecific proteins and the investment in a new bioprocessing production facility based in Landenberg, Pa., which complements its UK-based facility, providing dual-continent manufacturing capabilities to address growing customer demand.

At BIO 2024 in San Diego, Calif., which was held on June 3–6, Pharmaceutical Technology® Group’s Chris Spivey spoke with Hayley Crowe, executive vice-president and general manager Global Life Sciences, Ecolab. Crowe has a wealth of experience in bioprocessing, mass spectroscopy, and in life science R&D generally.

She pointed out that “the jetting technology has really changed the way we manufacture our Protein A resins. Historically, an emulsification process was used, which produces a wide range of bead sizes as a Gaussian distribution. If you say something is 50 microns, it might be 25 to 105 microns, which means a lot of post processing is needed to sieve out the fine [particles] and scale it down to the bead size you want.”

“In jetting,” Crowe explained, “you can actually dial it in…. we use acoustics [funneled through] a coke can, pushing the resins out, and are able to dial in the sizes. When we say 50 microns, its [variability] is 45 to 55 microns.”

Operational efficiencies from these resins include improved mass transfer kinetics and faster flow rates, but Crowe also pointed out that Ecolab is finding that “ [if] there are a lot of sustainability gains due to higher yields, [then] [w]e run fewer cycles, which reduces the total amount of water used in the process, along with reduced buffer usage. It is pretty incredible.”

The way the beads are formed with jetting technology lends themselves to having a higher ligand density, which allows for higher dynamic binding capacity (DCB). “Our newest product, launched this week at BIO, is proving to deliver these higher DCBs—we’ll say up to 80—but it is very molecule- and process-dependent, and we have customers gaining greater than that, in their early testing phases.”

Rounding out the conversation Crowe talked about security of supply. “We have dual-source supply with full lines of capacity in different regions, so you can obtain product should something go wrong. During COVID, we all experienced shortage of supply … the pain of living through that made us ask, what if that happened again, and are we prepared? If another pandemic or similar occurred, we’ve made sure we’d be ready to go,” she asserted.

Meanwhile, on current customer trends Crowe averred that, “We’ve transitioned into this plethora of different molecules, which makes a big difference in terms of purification resins. It’s not a one-size-fits-all anymore. And having a tool box where you are able to test different Protein A resins to give you the best yield, or to decrease aggregation, or to offer the best operational efficiency [means] it’s really important to test the different Protein A resins at this stage, and not just stick with the same thing that always worked for the [p]ast 30 or 40 years because, guess what, molecules are different now, and they behave differently.”

For more BIO 2024 coverage, click here.