Isomerase Therapeutics

Isomerase Therapeutics

Newnham Building, First Floor Chesterford Research Park, Cambridge CB10 1XL, United Kingdom

Fermentation

Fermentation

We recognise that the ability to grow microbes in a controlled environment is an essential capability in developing robust and scalable bioprocesses. We have significant experience in development, optimisation and scale-up of microbial fermentations for GMP and non-GMP use. We've worked with a wide variety of bacteria (inc. G+ve, G-ve and actinomycetes) and fungi (inc. basidiomycetes and ascomycetes). We have in-house fermentation capacity up to 20L and we work with a network of CMOs to take your process up to full commercial scale (e.g. 50,000L).

Our fermentation capabilities include:

Yields/Titres - we have extensive experience increasing yields and also in the reduction of unwanted related or side-products

Scale - we work at a variety of scales from high throughput systems such as plates, tubes and flasks through to bench- and small pilot-scale bioreactors

Process Control - we used advanced control capabilities for optimised aeration and feeding strategies

Technology Transfer - we have worked with our partners to ensure effective technology transfer during manufacturing campaigns including auditing CMO sites and on-site supervision of fermentation and DSP processes

GMP - we have experience of preparing and migrating fermentation and DSP processes through various regulatory phases - IND/NDA and preparation of CMC documentation

Scale-up/scale-down - we can troubleshoot challenging processes and deliver a robust, reproducible and scaleable batch recipe with validated in-process controls

Cost of Goods - we worked with partners to interrogate and improve the economics of their processes

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