A successful biomanufacturing process needs fit-for-purpose Upstream (USP) and Downstream Processes (DSP)Downstream Processes (DSP):
- Upstream operations comprise activities in the initial stages of a biotechnology process. This includes the generation and validation of cell banks, inoculation of media and seed cultures, production of fermentation media, the fermentation phase itself, and harvesting.
- Downstream operations encompass all processes that occur after harvest. These processes are highly product-specific and typically involve clarification, purification, and stabilization. Isomerase frequently uses lyophilization to stabilize protein products for storage.
Upstream fermentation capabilities
- Improving titers, 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 optimization.
- 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 Investigational New Drug (IND)/New Drug Application (NDA) and preparation of Chemistry, Manufacturing, and Controls (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.
- Manufacturing campaigns - We have worked with a variety of partners to manage external manufacturing campaigns - including project overview and on-site support.
To support these capabilities, we introduced an additional pilot-scale facility.
Our Biopilot facility
Our established Biopilot facility provides a robust and flexible platform for developing, optimizing and scaling bioprocesses. From microtiter plates to 3–7L stirred tank reactors, and up to 20–30L in-place sterilized tanks, our comprehensive range of fermentation systems seamlessly bridges the gap between your current scale and your production goals. Combined with comprehensive downstream processing capabilities, the Process Innovation team utilizes decades of fermentation experience to support material production up to a kilo scale.
We continue to use this facility to help our partners de-risk scale-up, refine their bioprocesses, and transition them smoothly to commercial manufacturing through our trusted CDMO network.
Microbial fermentation and contract fermentation process development
With applications across industries, large-scale biomanufacturing utilizes genetically engineered microbes (such as Escherichia coli or Bacillus subtilis). Our researchers understand these strains well and frequently use them as a platform to produce a variety of compounds and biocatalysts.
Examples of industries that utilize microbial fermentation:
- Pharmaceutical – Used in the production of medicines, vaccines, and diagnostic tools.
- Food & Beverage – Helps produce compounds that preserve food, enhance flavor, and extend shelf life.
- Agriculture – Fertilizers, pesticides, and feed additives to support crop growth and animal health can be produced by microbial fermentation.
Fungal Fermentation
Fungal strains can produce molecules that are difficult to synthesize using traditional chemical methods. Their sophisticated metabolic pathways allow them to produce a wide range of biomolecules, including enzymes, organic acids, and secondary metabolites.
Notable products derived from fungal fermentation include citric acid, penicillin, and lovastatin. Additionally, fungi are widely used to produce industrial enzymes for applications in the food, agriculture, and detergent industries.
Fungi are particularly well-suited for fermentation process development due to their ability to grow on a wide range of substrates, including agricultural residues and food waste. This not only enhances process flexibility but also supports environmental sustainability by repurposing waste materials. Moreover, replacing petrochemical-based synthesis with biological fermentation contributes to greener, more sustainable manufacturing practices.
Aims of contract fermentation process development
Through contract fermentation development, clients gain direct access to our expert knowledge, equipment, and a scalable production system. Our Process Innovation team works with companies to develop tailored methods that reach target product concentrations. This process can include optimizing fermentation conditions, developing media, or introducing new fermentation techniques.
Close collaboration ensures that every solution is aligned with your strategic goals. The services we provide help businesses innovate efficiently and stay competitive.
By choosing Isomerase as your fermentation development contractor, we can assist in:
- Reducing process costs – Through media refinement and scale-up process optimization.
- Speeding up development – Using our established Design of Experiment (DOE) approach.
- Minimizing risk – Through validated processes and comprehensive record-keeping
Why choose Isomerase for contract fermentation process development?
Here at Isomerase we specialize 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.