Bridging the gaps from small molecule testing to support next-generation biologics
Travis L. Emig, Vice President, BioPharma Chemistry, Eurofins BioPharma Product Testing, Lancaster, PA
No secret, the small molecule pharmaceutical product testing business has seen exponential growth during the past three decades. Now innovative advancements in biologic-based vaccines and therapeutics are compounding the growth of the traditional biologics market sector. This unprecedented demand is driving the need for the small molecule product testing and biologics worlds to come together to support these life-altering targeted medicines for patients.
In an effort to resource the evolving and dynamic industry, the Eurofins BPT small molecule analytical team in Lancaster, PA, is now diversifying its technical expertise and capabilities to take on intermediate molecules such as Peptides and Oligonucleotides. With many small molecule testing techniques paired with newer technology requirements, Eurofins BPT is establishing teams that will specialize in these categories of pharmaceutical products. Additionally, over the past 10 years the Lancaster site has established industry-leading expertise in non-compendial biologic-based Raw Materials testing with innovative platform method designs for media, resins, serums, cytokines, amino acids, and other starting materials for the support of CAR T cell therapies, and other Cell and Gene Therapies (CGT) or Advanced Therapeutic Medicinal Products (ATMPs). Eurofins BPT is investing heavily in this area to bridge any gaps between small molecule and large molecule analytical services.
While the diversification of skillsets and capabilities to support intermediate molecules is essential to align with the industry, Eurofins BPT has simultaneously continued to make significant investments and expand in small molecule excipient, API, and product testing areas.
Eurofins BPT US based locations offer the most comprehensive GxP small molecule testing services in our industry. Lancaster, PA; Portage, MI; and Eurofins BPT’s most recent acquisition, Eurofins Biopharma Product Testing ENCO, with locations in Jacksonville, FL, and Cary, NC, all specialize in analytical support for the traditional small molecule pharmaceutical industry.
Starting with Raw Materials and Excipient testing, the Eurofins BPT Lancaster, PA, site has been the industry-leading provider of Compendia and non-Compendia services for more than 25 years. Expertise in USP/EP/JP for commercial and R&D programs, plus the ability to establish customized methods has been a stronghold. Experience in trace metals and residual solvent analyses continue to be core offerings, and the team has already designed new state-of-the-art laboratory space that they will occupy when the next facility expansion on the Lancaster, PA, campus is completed.
Due to demand and capacity needs, along with risk mitigation efforts, the Portage, MI, site has an ongoing expansion of space and equipment to offer a full program of Compendia testing as well, with equipment being installed to have equivalent platforms between sites. Over $1M in capital was invested in the Portage site. Eurofins Biopharma Product Testing ENCO also provides Raw Materials/Compendia testing support within our US network. If there is a Raw Materials outsourcing need, the Eurofins BPT US network has a solution.
For API and Product testing support in the small molecule space, all three BPT entities have extensive chromatography capacity, can support testing for almost all formulations, have stability storage capacity for any ICH condition, and have experience to cover the entire drug development pipeline, from R&D through clinical, registration, and commercial support. From solid dosage to parenteral products, medicated devices and dermatologic formulations, Eurofins BPT can support almost any small molecule API or product program. The Eurofins Biopharma Product Testing ENCO site in Jacksonville can also provide capsule filling for analytical and clinical dosing support. Nearly 800 staff across these laboratory locations are ready to address any API or product testing need.
Our goal is simple: to evolve in a manner that allows us to support our client base as the product pipelines in many organizations advance, and make it easy for customers to always have a viable external partner to support any testing challenge. Eurofins BPT US continually ensures our traditional chemistry business stays aligned with customers’ everchanging small and large goals.