Why outsource bioprocessing?
Summary
From sequence to 30 L and manufacturing scale, why outsourcing saves resources in the long run and makes economic sense.- Author Company: Isomerase
- Author Name: Andy Budde
- Author Email: bd@isomerase.co.uk
- Author Website: https://www.isomerase.com
Isomerase is a leading bioprocessing company that offers partners the ability to scale up their processes or projects from the lab to industrial manufacturing. Partners from various industries, including pharma, biotech, as well as food and ingredients, opt to work with our bioprocessing services when scaling.
In this article, we provide an overview of what we offer, enabling you to make an informed decision when considering outsourcing.
What is microbial bioprocessing?
Once a microbe and the product of interest have been optimised, by engineering the production strain and/or target sequence, the process needs to be scaled. Generating such a product within a living organism at manufacturing scale is termed bioprocessing.
Due to mechanical and biological complexities, scale-up is not as simple as proportionately increasing vessel dimensions, media composition, or cell densities.
Instead, we must employ a combination of deep expertise, specialist equipment, and complex statistics-based experimental design (DoE) to optimize a process.
Why outsource during scale-up?
Even with a microbiological background, advancing beyond lab-scale often means drastic resource expenditure for facilities, equipment, and training. Additionally, these requirements for bioprocess development are usually only needed once for a relatively short time.
By outsourcing your project during scale-up, you save on all these expenditures and ensure your process is fully optimised.
Our bioprocessing services
Interested in working with Isomerase? Below are the five core parts of our services that we offer.
Specialist biopilot facility
Located just outside Cambridge, UK, is our non-GMP biopilot facility, Solopark, dedicated to serving our scale-up capabilities. Within Solopark, we have various bioreactors allowing us to offer support from bench-top to 30 L scale. For a list of all the equipment we have, please see our bioprocess development brochure.
Due to the size of this facility, we can accommodate specialist equipment upon request.
Team with 20+ years of experience
Our team has worked on various projects ranging from material supply to process optimisation, each with its own intricacies and unique challenges.
As such, we will be able to support projects with varying requirements and development stages.
Upstream bioprocessing services
Upstream process development (USP) refers to everything after product harvest, including media optimisation, culture preparation, and cell separation.
Case study
Problem: An agrichemicals company sought to isolate new active compounds.
Our approach:
- Developed master and working cell banks, alongside fermentation, analytical, and isolation procedures.
- Targeted process improvement was implemented to enhance the production of microbial strains.
- Initial compounds' activity was tested, and selection was made for further development.
- Additional rounds of process optimisation and scale-up.
Results: Gram quantities of the selected products for further testing.
Downstream bioprocessing services
After USP, we then employ our downstream process development (DSP) to isolate a target product from the crude extract. During this purification stage, the techniques we use depend largely on our clients' purity requirements.
Case study
Problem: A chemical manufacturer needed to make a biocatalysis process more efficient.
Our approach:
- A unique method was developed to isolate lyophilized enzymes directly from the fermentation broth.
Results: Efficient recovery of active enzymes streamlined the production process, allowing repetitive use in biocatalytic applications.
Manufacturing scale-up and tech transfer
Once optimised and scaled to 30 L, we then engage with our CDMO network, providing manufacturing capabilities up to 100,000 L.
Case study
Problem: Our client had previously tried to scale their process beyond 100 L for kilogram production. However, due to a suboptimal process, this was unachievable.
Our approach:
- Identified areas of their current process to optimise.
- Created detailed Request for Proposals to carefully selected CMOs.
- Evaluated tenders for technical and economic viability.
- Executed tech transfer with the client and CMO, with staff on site to ensure protocol adherence.
Result: Process scaled to 50,000 L.
Contact us today to find out how we can help with your process or project.
