Rentschler Biotechnologie GmbH, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, and Rentschler Fill Solutions GmbH, an independent specialist for aseptic fill and finish services, today announced a strategic partnership to provide new state-of-the-art fill and finish facilities and one-stop solutions for biopharmaceutical products to meet the needs of Rentschler Biotechnologie’s clients.
Under the terms of the agreement, Rentschler Fill Solutions will prospectively serve as the exclusive partner for the fill and finish services of Rentschler Biotechnologie’s manufacturing projects. Rentschler Fill Solutions is owned by the Rentschler family and will begin operations in mid-2018. In addition to servicing Rentschler Biotechnologie’s clients, Rentschler Fill Solutions will offer its fill and finish services on a clinical as well as commercial scale to its own client base.
"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. 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," Dr Frank Mathias, CEO of Rentschler Biotechnologie, commented.
"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."
At the Rentschler Fill Solutions facility in Austria, state-of-the-art advanced aseptic filling technology will be employed. Vials from DIN2R up to 50 mL can be used for the aseptic filling of liquid or lyophilized biopharmaceuticals in small to medium-sized batches. Up to 60,000 vials per batch can be filled. Timelines and batch sizes can be tailored and flexibly scaled. Standardised and aligned processes and packages enable fast-track services while single-use equipment guarantees maximum product safety. The Rentschler Fill Solutions facility complies with all required regulatory standards and is designed to enable future expansion without interrupting ongoing operations.
"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," added Reinhold Elsaesser, General Manager of Rentschler Fill Solutions. "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."
Rentschler Biotechnologie and Rentschler Fill Solutions will introduce their partnership and service offering at the BIO International Convention in hall C, booth 1929, taking place June 19-22 in San Diego, CA, US.
Rentschler Biotechnologie GmbH, located in Laupheim, Germany, is a leading contract development and manufacturing organization (CDMO) for bioprocess development and manufacturing of biopharmaceuticals as well as for related consulting activities in terms of project management and regulatory support. The Company’s clients include innovative biotech companies and major pharmaceutical companies around the world. Many years of experience and excellence in finding solutions as well as certified quality management and advanced technologies ensure Rentschler’s high quality standards. Rentschler Biotechnologie is a family-owned company employing approximately 700 people.
Rentschler Fill Solutions GmbH, located in Rankweil, Austria, is an independent contract manufacturing organization (CMO) for the aseptic filling of liquid and lyophilized biopharmaceutical products. The Company provides state-of-the-art facilities which comply with the latest regulatory, quality and safety standards. Rentschler Fill Solutions focuses on delivering small to medium-sized batches (up to 60,000 vials per batch) to meet clinical as well as market needs through all stages with its highly scalable solutions. Rentschler Fill Solutions is a family-owned company with a highly skilled team offering extensive experience and reliable services in aseptic filling. Operations are planned to start in mid-2018.
The strategic partnership of Rentschler Biotechnologie and Rentschler Fill Solutions provides clients with one-stop solutions from gene to vial and unites two centers of excellence for the fast and efficient bioprocess development, manufacturing and filling of biopharmaceuticals with the Rentschler commitment to quality. Both companies are owned by the Rentschler family, which has been a trusted and successful partner in the pharmaceutical industry for five generations. While the Companies remain independent of one another, Rentschler Fill Solutions will serve as exclusive partner for the fill and finish of Rentschler Biotechnologie’s full-service manufacturing projects.