MilliporeSigma has teamed with ReForm Biologics to develop and license excipients for use in biologic formulations.
The agreement will see the life science business of Germany’s Merck KGaA – known as MilliporeSigma in North America – access proprietary excipients from ReForm Biologics.
The bioprocess vendor will fund the development of these excipients for use in the formulation of biological drugs, as well as take charge of manufacturing and commercializing them.
“The parties have agreed to keep the exact terms to the agreement confidential, but we will be able to sublicense the technology to interested biopharmaceutical companies,” MilliporeSigma spokesperson Karen Tiano told this publication.
“We strongly believe that ReForm Biologics’s proprietary excipients that are subject to this agreement will aid in providing a broader range of solutions to help solve today’s main formulation challenges in biologics,” she added.
The excipients are based on ReForm Biologics’ formulation technology platform, which the Massachusetts-based firm says can extend product lifecycles, enable alternative dosing, and improve manufacturing efficiency for biologic makers.
The technologies offered by the firm includes viscosity-reducing excipients for high concentration biologic formulations, stability-enhancing excipients to prevent aggregation and particle formation in biologics, and surfactant-replacing excipients to avoid the degradation problems that accompany known surfactants for biological formulations.
“ReForm Biologics’ proprietary excipients are very well known in terms of chemistry and have already been parenterally applied in humans,” Tiano said. “We strive to provide support to ensure compliance with applicable regulations.”
Bioprocess vendors have a reputation for eventually acquiring their technology partners. Examples include Sartorius buying long-term PAT and QbD software partner MKS Instruments, Thermo Fisher buying its long-term collaborator Finesse solutions, and GE Healthcare investing in automation partner Zenith Technologies.
When asked about MilliporeSigma’s intentions for ReForm, Tiano said: “This is a global license agreement and collaboration to commercialize proprietary ReForm excipients used in biotherapeutic formulations at this point in time.”