Case study: Lyophilised Exosomes for Injection Formulation Development and Cycle Optimisation

ABSTRACT:

Recently, a collaborative project between Biopharma Group, a leading CDMO specialising in lyophilization, and a prominent US-based customer commenced. The objective of this partnership was to enhance an existing lyophilized product containing exosomes for drug delivery in gene therapy. the primary aims of this project were to preserve the exosome structure during the lyophilization process, reduce cycle times, and improve the acceptance rates of lyophilized batches. 

The decision to undertake this project was informed by a thorough assessment of its potential commercial and operational benefits. Notably, the return on investmentbecame evident, considering the elimination of the cold chain requirement (storage at -20°C), optimisation of storage and transportation, streamlining of operations, and the overall enhancement of product quality.

This case study poster provides both a commercial and scientific overview of  this cutting-edge R&D project.

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