For partners with processes close to, or already at, manufacturing stage, Isomerase can provide a range of support including process optimisation and troubleshooting alongside experienced consultancy.
We’ve taken processes from lab scale all the way to full manufacturing and product approval and we understand the challenges of migrating a process from a research environment to a more regulated manufacturing phase. We can help support you through these transitions and ensure an effective and successful campaign.
Examples of where we can help include:
- Medium Optimisation - we can often identify improvements in medium recipes
- Cell Banks - we can produce and qualify MCBs and WCBs for manufacturing campaigns
- Seed Train - optimisation for scale and reproducibility
- Product Capture - we can optimise and develop scalable primary product capture and extraction
- Product Purification - optimisation of liquid/liquid extraction, chromatography, crystallisation, etc.
- In-process Controls - determination and validation of robust and predictable in-process control points
- Stress-testing and Hold-point Analysis
- CMOs - we can provide hands on assistance with CMO selection and facility audits
- Tech Transfer and Consultancy - we can support the development of robust microbial processes and suitable documentation to support effective transfer to third parties
- Manufacturing Campaigns - we've worked with a variety of partners to manage external manufacturing campaigns - including project overview and on-site support