As a microbial fermentation CRO and innovation partner in the field of contract fermentation process development, Isomerase can provide a range of biomanufacturing support for clients with processes nearing or at the manufacturing stage. These include process optimisation and troubleshooting alongside specialist consultancy.
Isomerase can also provide lab and pilot-scale fermentation development services. We have taken processes from lab scale all the way to full manufacturing, 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.
A successful biomanufacturing process needs both a fit-for-purpose Upstream (USP) and Downstream Processes (DSP ). The upstream process comprises activities in the initial stages of a biotechnology process. This includes the generation and validation of cell banks (such as working cell banks (WCBs) and master cell banks (MCBs)), inoculation of media and seed cultures, production of fermentation media, the fermentation phase itself and harvesting. The downstream operations consist of clarifying and purifying the product from the harvested material.
Within our new Biopilot facility, we provide access to fermentation scales from microtitre plate, through to 3 or 7L stirred tank reactors, up to 20/30L in-place sterilized tanks. These allow us to generate material up to a gram or even kilo scale and develop processes fit for scaling to whatever larger scale is required, through a pre-selected CDMO or via our network of CDMOs.
We develop our processes through a combination of experience, know-how and Design of Experiment (DoE) approaches applied to appropriate process areas through quality by design (QbD) risk assessment platforms.
Examples of our collaborative work include:
- Improving titres, rates and yields - we have extensive contract fermentation process development experience improving USP and DSP stages including the reduction of unwanted side-products. We routinely use statistical experimental design to help accelerate process optimisation.
- Scale-up and tech transfer - we’ve taken early-stage projects from the lab through to the manufacturing scale. We have provided consultancy, prepared tech transfer documentation, Requests for Quotation, facility audits, etc. to help our collaborators select a suitable CDMO and de-risk scale-up. We can even provide experienced personnel on-site during manufacturing campaigns
- GMP support - we have experience in developing and supporting USP and DSP processes through various regulatory phases including IND/NDA and preparation of CMC documentation
- Technoeconomic modelling - we have developed bespoke models to allow our partners to assess the economics and major cost sensitivities for various products including APIs, bioactives for agritech and animal health, and bioprocessing routes to biopolymers and specialty chemicals.
- Piloting facility - Isomerase has recently completed commissioning a new facility for piloting bioprocesses (Biopilot) including a range of benchtop and SIP bioreactors and a suite of supporting DSP equipment. The new facility is already helping partners to de-risk scale up, optimize their bioprocesses, and provide a flexible facility for material supply up to a kilo scale.
- Manufacturing campaigns - We have worked with a variety of partners to manage external manufacturing campaigns - including project overview and on-site support
Microbial fermentation and contract fermentation process development
Microbial fermentation is a versatile process that has many different applications in various industries. It plays a huge role in Biopharmaceuticals and the production of them, including therapeutic proteins and vaccines. Genetically engineered microorganisms like bacteria (such as Escherichia coli or Bacillus subtilis) and yeast (such as Pichia pastoris or Saccharomyces cerevisiae) are utilised to produce these medical compounds on a large scale. Contract fermentation process development enables generation of processes that are scalable and technoeconomically viable.
Precision fermentation is used widely in the production of food and drinks. It is used to generate novel flavour molecules and flavour enhancers.
Microbial fermentation can be used in agriculture, such as in the production of organic fertilisers, seed coatings and soil conditioners to enhance soil fertility and crop yields.
Fungal fermentation is a process that can be used to produce a wide range of products, including enzymes , organic acids, and secondary metabolites.
Fungi are particularly useful for fermentation process development because they are able to grow on a wide range of substrates and can produce complex molecules that are difficult to synthesise using traditional chemical methods. Some examples of products that can be produced using fungal fermentation include citric acid, penicillin, and lovastatin, which is a cholesterol-lowering drug. However, it also can be used to produce enzymes that are used in a variety of industries including food, agriculture, and detergents.
Fungal fermentation is also being explored as a sustainable alternative to traditional chemical synthesis methods. By using fungi to produce valuable molecules, businesses can reduce their reliance on petrochemicals and other non-renewable sources, leading to a more sustainable and environmentally friendly production process. Additionally, fungi are able to grow on waste materials, such as agricultural residues or food waste, further reducing the environmental impact of the fermentation process.
Fungal fermentation can be used to produce a wide range of products, including those that are difficult or impossible to synthesise using traditional chemical methods, making it an attractive option for businesses looking to develop new products.
Aims of contract fermentation process development
The aims of contract fermentation process development are to provide businesses with flexible and cost-effective fermentation solutions that are optimised for their specific needs.
Some of the key benefits of contract fermentation process development for us include access to specialised expertise, state-of-the-art equipment, and a flexible and scalable production process. Developers also collaborate with businesses to develop custom products tailored to their specific requirements. This may involve the optimization of fermentation conditions, genetic engineering or microbial strains, or the development of novel fermentation techniques to produce unique or special products and meet regulatory standards.
Overall, this service is invaluable and can help businesses achieve their fermentation goals in a cost-effective and efficient manner, while also providing them with the flexibility to adapt to changing market conditions and emerging technologies.
Why choose Isomerase for contract fermentation process development?
Here at Isomerase we specialise in biotechnology and offer contract fermentation process development capabilities from our modern, well-equipped laboratory near Cambridge UK.
We are committed to the socially responsible development and use of biotechnology to help improve people's lives and reduce the overall environmental impact of manufacturing.
Contact us about upstream process development
Contact us for more information about our bioprocess development or contract fermentation process development services and request a quote from us today.