Isomerase is a leader in contract fermentation process development, scaling processes from the lab to manufacturing scale through our Process Innovation facility.
Our team are experts in Upstream Process Development (USP), Downstream Process Development (DSP), as well as tech transfer and scale up. With our facilities, we provide clients with bioprocess development, optimization, troubleshooting and regulatory support for specialized, flexible and cost-effective fermentation solutions.
Upstream Bioprocess Development (USP)
- Generation and validation of cell banks - e.g. working cell banks (WCBs) and master cell banks (MCBs).
- Inoculation of media and seed cultures.
- Production of fermentation media.
- Fermentation phase and harvesting.
- Improved titers, rates and yields - reduced unwanted side-product and accelerated process optimization with statistical experimental design.
Downstream Bioprocess Development (DSP)
- Cell separation - e.g. centrifugation, membrane filtration.
- Cell disruption - e.g. homogenization or sonication.
- Extraction - e.g. solvent extraction.
- Isolation - generally initial enrichment of the target product.
- Purification - generally final purification of the product to levels required for release.
- Drying - e.g. lyophilization or spray drying.
- Lab-scale DSP for compound supply.
- Fully developed DSP for tech transfer to CDMO.
- Design of Experiments (DoE) approaches used throughout.
CDMO Tech Transfer and Scale Up
- Generating robust processes and detailed documentation.
- Generating and sending out requests for quote (RFQ) - leverages Isomerase’s large network of CDMOs.
- Selection of most appropriate supplier.
- Technical transfer of the process.
- Management of process life cycle - e.g. putting “boots on the ground”.
- Reduced risks and costs - minimized roadblocks and delays during scale-up means quicker time to market.
Process Innovation Facility
As part of our bioprocess development services, we provide access to our Process Innovation facility at Solopark, Cambridge. utilizing our experience, Design of Experiments (DoE) approaches, and quality by design (QbD) risk assessment we provide encompassing bioprocess development services on scales including microtiter plate, 3 L and 7 L stirred tank reactors, as well as 20/30 L in-place sterilised tanks.
Why choose Isomerase as your process innovation partner?
At Isomerase, we provide end-to-end Upstream and Downstream process development expertise, from lab-scale microbial fermentation to pilot-scale and full-scale manufacturing. Our team of bioprocess engineers, molecular biologists, and analytical chemists, ensure a collaborative, multidisciplinary approach to increase the likelihood of commercial success.
With a strong commitment to innovation and responsible biotechnology, Isomerase delivers customized, high-quality solutions to help clients de-risk scale-up, enhance process efficiency, and accelerate time to market.