LAUPHEIM, Germany & RANKWEIL, Austria —Rentschler Biotechnologie and Rentschler Fill Solutions recently announced a strategic partnership that unites two companies owned by the same family but independently managed and operated. Rentschler Biotechnologie GmbH, based in Germany, is a leading contract development and manufacturing organization (CDMO) for bioprocess development and manufacturing of biopharmaceuticals. Rentschler Fill Solutions, located in Austria, provides new state-of-the-art fill and finish facilities and one-stop solutions for biopharmaceutical products. While the companies remain independent of one another, Rentschler Fill Solutions will serve as the exclusive partner for the fill-and-finish work of Rentschler Biotechnologie's full-service clinical manufacturing projects, while continuing to serve its own client base on a clinical and commercial scale.
As a CDMO, Rentschler Biotechnologie specializes in developing stable cell lines and establishes cell banks (master cell banks and working cell banks), as well as developing and optimizing processes for the manufacturing and purification of recombinant proteins. The company operates active pharmaceutical ingredient manufacturing in its cGMP facilities, offering scalable development for clinical trials as well as for market supply. Its clients include innovative biotech companies and major pharmaceutical companies around the world.
“Based on the maturity of the biotech industry and demand for new drugs in growing international markets, we are also seeing more and more demand not only in terms of manufacturing for clinical studies, but for commercial-scale manufacturing and market supply,” commented Dr. Frank Mathias, CEO of Rentschler Biotechnologie. “In order to manage the expected growth and provide clients with new, scalable, state-of-the art technologies and facilities, this new partnership with Rentschler Fill Solutions will allow us to meet today’s and the future needs of our clients.
“Rentschler Biotechnologie is continually seeking and improving ways to help clients achieve their goals, all along the value chain—from cell line development through finished products. This partnership also supports our recent strategic alliance with Leukocare, as improved formulation strategies will contribute to the quality of the fill-and-finish process. Both partnerships will enable us to serve our clients as they grow.”
Rentschler Fill Solutions specializes in aseptic filling and freeze-drying of biopharmaceutical products. Their top asset is the safe manufacture of sterile biopharmaceuticals for clinical studies and market supply in small to medium-sized batches. Substance classes that are filled include recombinant proteins (for example, antibodies and fusion proteins) as well as peptides, small molecules and placebos. The company provides customers worldwide with support from delivery of the active substance until shipment of the filled product. The manufacturing processes of Rentschler Fill Solutions are precisely geared toward the target portfolio for clinical phases and initial orphan drug market supply. Timelines and batch sizes can be tailored and flexibly scaled, and standardized and aligned processes and packages enable fast-track services while single-use equipment guarantees maximum product safety, according to the company.
“Our state-of-the-art fill-and-finish facility has been designed to deliver high-quality products and reliable services to our clients. As an independent specialist for the aseptic filling of liquid and lyophilized biopharmaceuticals, we aim to manage the specific filling requirements of a wide range of biopharmaceutical companies from clinical studies through market supply,” said Reinhold Elsaesser, general manager of Rentschler Fill Solutions.
This strategic partnership will provide their clients with one-stop solutions from gene to vial and facilitate fast and efficient bioprocess development, manufacturing and filling of biopharmaceuticals within the Rentschler family portfolio of businesses.
“We very much look forward to working with Rentschler Biotechnologie to address clinical and market needs in terms of capacity, scalability, time to market, purity and safety. The clients of both companies will benefit from reliable one-stop solutions and a fast time to market based on our common commitment to quality and aligned processes,” adds Elsaesser.