The high efficacy of Protein A means the resin remains the gold standard in capturing monoclonal antibodies during the chromatography process despite its hefty price-tag which - due to being made in a similar way to an actual biologic - can account for up to 30% of the total cost of production.
Therefore the increased number of mAbs being approved in the US is driving continued growth for Repligen, a manufacturer and supplier of the Protein A ligands used in the resin, the firm said during its Q2 2016 conference call yesterday.
“Given the direct tie of our ligands business to the production of monoclonal antibodies, we continue to be encouraged by high approval rates with six FDA approvals this year."
On top of the new molecular entities (NMEs) Anthim (obiltoxaximab), Taltz (ixekizumab), Cinqair (reslizumab), Tecentriq (atezolizumab), and Zinbryta (daclizumab), the US Food and Drug Administration (FDA) approved the first biosimilar mAb in April, Inflectra – a version of J&J’s Remicade (infliximab) being marketed by Pfizer.
“Keeping in mind that the demand for the products Repligen manufacturers is based on volume, we believe this dynamic is creating additional opportunities for our business.”
Repligen makes the ligands from its facilities in Lund, Sweden and Waltham, Massachusetts, and recently extended an agreement to supply the product to GE Healthcare through to 2021 and struck a long-term supply deal with Purolite.
Purolite is currently building a plant in Llantrisant, UK with capacity to produce 100,000L of its resin once validation is complete, around April next year.
“I think that GE and Purolite are probably looking out two or three years, so I think they are just gearing themselves up, you know, to be able to meet demands up till 2020.”
For the second quarter, the firm saw record growth with sales of $29m, up 36% year-over-year.
While Protein A has traditionally represented the majority of Repligen’s business, the firm has been diversifying its portfolio over the past few years, focusing on bioprocessing tools and equipment, and now attributes as much as 50% of its revenues to its upstream and downstream offerings.
And, as with Protein A, Hunt attributed continued growing demand for the systems to the robust end-user market
“We're encouraged by the strength in our end markets and the overall trends in our industry. Our biopharma customers our investing capital expansion project to increase overall capacity at their facilities as the biologic and biosimilar market grows.”
The firm bolstered its downstream offering through the acquisition of prepacked chromatography column maker Atoll in April, while in 2014 the firm bought the assets of Refine Technology adding the Alternating Flow (ATF) cell retention system to its upstream portfolio.