Rentschler: Stabilisation tech sparks 'paradigm shift' for bio-formulation services

By Dan Stanton contact

- Last updated on GMT

Image: iStock/koo_mikko
Image: iStock/koo_mikko
Rentschler Biotechnologie has added an antibody stabilising platform to its manufacturing services through a strategic alliance with formulation tech firm Leukocare.

The deal – financials of which have not been disclosed – sees the contract development and manufacturing organisation (CDMO) take a 10% share in fellow Gemany-based firm Leukocare, while adding what Rentschler spokeswoman Marion Schrader said was “a best-in-class formulation”​ technology.

“Rentschler will become the first and only CDMO to have access to Leukocare´s patented SPS formulation technologies,”​ she told Biopharma-Reporter.com.

The SPS – or Stabilizing and Protecting Solutions – technology platform has the ability to stabilise and protect biopharmaceuticals, including therapeutic antibodies, she said.

“SPS are specific compositions of usually 5-8 different selected and regulatory well known excipients out of a library of up to 100 different ones. The formulations offer high stability of proteins in lyophilised or liquid formulations, preventing aggregation and oxidation etc. while fully preserving the functionality of the respective target protein.”

The platform is desirable from Rentschler’s point of view as there is a need to ensure that the end products of our clients will, from the very beginning, have a best-in-class formulation.”

Schrader continued, adding the alliance “is about to initiate a paradigm shift”​ by introducing a full-service concept approach in the development of biopharmaceuticals.

“The SPS formulation technology platform provides this best-in-class stability and allows the development of pharmaceutical formulations in a shorter period of time. This results in a much higher probability of success to develop pharmaceutical formulations meeting defined objectives.”

The platform will be operated from Leukocare’s site in Martinsried, near Munich, with the firm doing the formulation development as requested by Rentschler´s clients.

This is the latest investment by Rentschler which has pursued and completed a series of facility expansions over the past few years​. The latest saw it add a second 2,000L single-use bioreactor​ at its plant in Laupheim.

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