Case Study

Advanced Formulation Development By Design In The Context Of Holistic Drug Production

By Latika Bhonsle-Deeng, Rentschler Biopharma SE, and Konstantin Petropoulos, LEUKOCARE AG

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A strong trend in drug substance (DS) and drug product (DP) biomanufacturing, as is for formulation, is that of increasing therapeutic complexity. These challenges of evolving sophistication take on a new meaning in an ever rapidly changing biopharmaceutical landscape. Solving the complex challenges of tomorrow, calls for innovative mindsets, technological advancement, and proficient and complementary expertise. This need led to the forging of the strategic alliance between biomanufacturing expert Rentschler Biopharma SE and formulation specialist Leukocare AG (Figure 1).

Leukocare is a top formulation development specialist in services tailored to client needs. Rentschler Biopharma SE is a leading global contract development and manufacturing organization (CDMO) renowned for its excellent process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. Both companies have been collaborating since February 2017, to offer biologics and biosimilar makers a competitive edge through significantly stabilized end products. Leukocare is the specialized technology partner and the exclusive formulation developer for Rentschler Biopharma’s biopharmaceutical development and biomanufacturing business. By combining well established scientific know-how and a commitment to high-quality, this strategic alliance leaves no stone unturned for the benefit of clients and their patients. Till date, the alliance has provided numerous clients with tremendous commercial advantage, by leveraging high-quality formulation developments.

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