Help with strain optimisation
A scalable, consistent and efficient manufacturing strain providing sufficient product titre is a pre-requisite for the success of any biomanufacturing project. A suitable strain is at the heart of a quality CMC package, which is fundamental for delivering the out-licensing, sale or commercial launch plan for your products.
A manufacturing strain capable of supporting pre-clinical and/or clinical development may not pass the rigorous standards required for larger scale commercially competitive manufacture. In such circumstances ‘locking in’ to an existing strain or an easier expression host such as E. coli, may seem pragmatic for budget or timescale reasons, but can be at the expense of delivering a commercially viable project that survives the scrutiny of due diligence.
QTL multi-parameter optimisation strain technology leverages evolutionary techniques to overcome the limitations of standard single-step genetic engineering of fixed host cell genome chassis approaches. For the first time, this allows the creation of a production strain that is fully optimised to each biological therapeutic that is fast, affordable and does not delay your existing project development.
How we help: Creating a high-performance strain
Deficits in strain performance may already be known, or may only become obvious, during scale-up. They include insufficient titre, downstream processing complexity and/or losses, post-translational modifications, plasmid instability, purification challenges including the use of toxic or dangerous reagents, as well as consistency and scaling issues.
Standard genomic chassis or genetically engineered variants of host cells such as E. coli, Pichia pastoris and CHO have inherent limitations. Our proprietary QTL technology overcomes these limitations making genuine multi-parameter strain optimisation possible for the first time.
How we help: Parallel strain development
An optimised manufacturing strain tailored to your biological therapeutic can be developed affordably and quickly in parallel with your existing development activities. Using a bridging study, a retrospective CMC submission can be made to regulators to subsequently switch the manufacturing strain and process, a proposition which may make the difference to in-licensors who otherwise assess the manufacturing solution as unviable at large scale.
A patent protected optimal strain can not only add considerable value to any biological therapeutic, it can be the difference between an out-license or acquisition completing or failing in due diligence.
Why choose us?
Our unique QTL technology delivers genuine multi-parameter optimisation, surpassing standard approaches and unlocking your product’s full potential. With clearly defined stages, pre-agreed fees, and transparent licensing terms, we ensure confidence and transparency in our partnership. Moreover, our expertise in creating bespoke strains tailored to your CMC needs and enhances transaction readiness, providing you with a reliable fallback option and increasing the value and likelihood of your product’s commercial success.
Our standard process
- Initial evaluation: feasibility of production and initial titre evaluation
- Objective: Establish secretion of your product in our proprietary libraries, including initial titre benchmarking.
- Timeframe: 4-6 weeks design, 4-6 weeks implementation.
- Risk overcome: Initial secretion and titre of your specified product establishes the basis for optimisation using QTL technology.
- Cost: Per project basis.
- Breeding cycles and titre optimisation
- Objective: The better performing strains from Stage 1 are used for breeding, screening and QTL analysis, followed by iteration to achieve optimum titre and other specified strain characteristics.
- Timeframe: 10-12 weeks.
- Risk overcome: Optimised strains with fermentation data demonstrate the desired characteristics, with verified bioanalytics of your product.
- Cost: Per project basis
- Stability testing and cell bank creation
- Objective: Standard stability testing and creation of reseach cell banks.
- Timeframe: 12-16 weeks
- Risk overcome: The strain is ready for transfer and scale-up for clinical batch and commercial supply manufacture.
- Cost: Per project basis
Our partners trust us
Our proven track record includes developing swift and validated solutions to complex problems, such as enabling vaccines to be more accessible with support from the Bill & Melinda Gates Foundation. We continue to overcome production limitations, enabling market expansion.
What we can do for you
While we don’t promise the earth, our technology and our expertise in recombinant protein manufacture and evolutionary genomics research enable us to select the manufacturing solutions that we know we can deliver, with a high level of confidence, from the outset. We don’t waste your money, and our resources, unless the solution looks deliverable.
What happens next?
Get in touch
Contact us below to set up an evaluation call with our team. We will assess your project’s needs, technical challenges, and CMC requirements to develop an understanding of the recombinant protein and market demands you are dealing with. This enables us to align our QTL technology with your requirements, ensuring your production strain is optimised for both performance and regulatory compliance.
