Benefits of combining bioinformatics and an algorithm- and database-driven approach for biopharmaceutical stabilization


Article on how we maximize API potential for clients via our strategic alliance with Leukocare

Key to the success of the Rentschler Biopharma - Leukocare alliance has been the early deployment of tailored and potentially commercially viable formulations, for client benefit. These have enabled (i) reduced time-to-market, (ii) higher success probability, as well as (iii) added advantages due to intellectual property generation, that further adds to a product’s competitive edge.

A selection of case studies elaborating on the approach of exploring a broader design space to avoid high-throughput-screening, while improving stability and quality of biologics, has been presented in the October Issue of Contract Pharma.

These include formulation development for a designer molecule that was in preparation to enter clinical studies. A database and algorithm-based formulation approach were implemented in this project, to sequentially improve formulation candidates, leading to high stability. This ultimately resulted in the best-suitable liquid storage formulation for the candidate molecule.

Key to the success of this project was the in-depth expertise in stabilizing effects, related to a multitude of excipients, relevant for the stabilization of biologics such as amino acids and a combination of the same.  The implementation of formulation development know-how in downstream processing of this molecule resulted in increased product yield as well. This elegantly reflects the strength of this alliance and the immense benefits of the close collaboration for our clients.

The article has been jointly authored by Konstantin Petropoulos, VP & Head of Business Development, Marketing & Sales at Leukocare and Latika Bhonsle-Deeng, Manager Corporate Communication.

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