We work with partners where the focus is on generating enough material for the next milestone in their project, such as for testing in an assay or for validation studies with partners.
Using our new Biopilot facility we can deliver proteins, enzymes, peptides and small molecules including natural products from milligram to kilogram scale (depending on the productivity of the process, on a non-GMP basis).
We have taken processes from lab-scale fermentation all the way to full manufacturing and product approval. We understand the challenges of migrating a process from a research environment to a more regulated manufacturing phase, using a variety of scales with toll fermentation providers. We can support you through these transitions and ensure an effective and successful campaign.
Examples of how Isomerase can support material supply
Examples of where we can help include:
- Rapid supply of milligram quantities of natural products – where a strain is known, perhaps in the literature or from an initial screening campaign, we can rapidly generate lab-scale fermentation processes and downstream processing (DSP) to get milligram quantities for proof-of-concept assays.
- Supply of gram quantities of small molecules including natural products - from existing or newly developed bioprocesses using lab-scale fermentation and DSP we can take your process through pilot scale to get the quantities you need.
- Supply of milligram, gram or kilogram quantities of lyophilised proteins including enzymes - we have developed in-house fermentation and DSP processes to take industrial strains, such as Escherichia coli, Saccharomyces cerevisiae and Pichia pastoris rapidly from concept to isolated protein.
- Recombinant peptide manufacture - we have proprietary methods for generating recombinant peptides from larger than 20 amino acids in length with a focus on reducing the commercial cost of goods. Isomerase also has extensive experience with peptide manufacture more broadly.
- Support with scaled non-GMP or GMP campaigns – We have established a trusted network of toll manufacturers at a variety of scales all over the world. We can support CDMO selection from our network or perform due diligence on candidates selected by Partners. We can also manage tech transfer and validate the success of that transfer by putting boots on the ground to help manage the scale-up campaign.
- Cell Banks - we can assist with, produce and qualify master cell banks (MCBs) and working cell banks (WCBs) for manufacturing campaigns.
How can working with Isomerase increase the chance of a successful CDMO campaign?
Each of the steps of scaled manufacture carries risks of failure. From tech transfer to testing the robustness of processes with pilot scale fermentation and DSP, the team at Isomerase are used to supporting Partners right through the process with toll manufacture and scaled manufacture campaigns. We have experience with peptide manufacture, small molecule including natural product manufacture, enzyme and other protein manufacture and can support all stages of the process.
Contact us for more information
Contact us for a quote or proposal or for more information about recombinant peptide manufacture, lab or pilot scale manufacture, support with scaled fermentation or how we can optimally supply the material you need for your biotech project.