Process Demonstration

Based on decades of experience, our process development focuses on efficient and cost-effective production, advancing your candidate molecule through the best manufacturing route. By integrating chemical and biological processes, we expand manufacturing capabilities, combining the strengths of both to enhance productivity and effectiveness. This approach enables rapid delivery of candidate drug substance material for IND.

Below you can read more about our services.

Biocatalyst Production

Scalable biocatalyst production systems best suited to your needs.

Our services include:

  • Intracellular production or secretion of enzymes from diverse production hosts and optimised protein export systems.
  • codABLE™ gene design algorithm consistently outperforming leading gene synthesis providers in efficiency of biocatalyst production.
  • Bioinformatic and phylogenetic empowered identification and screening of commercial enzymes and novel biocatalysts, assessed in parallel using our diverse recombinant microbial expression systems.
  • Adapting the biocatalyst to meet your process requirements:
    • Enzyme evolution-driven enhancement of catalytic efficiency and selectivity, eliminating allosteric product inhibition and adaptation of biocatalyst specificity, stability and operational tolerances.
    • High throughput colorimetric/fluorometric/chemo-enzymatic screens and activity-based selection to enhance whole cell, individual enzyme and/or enzyme cascade performance.
    • Integrated targeted proteomics LC-MS/MS for reliable enzyme identification, characterisation and quantitation.
    • Screens or selections established to engineer onboarded strains for high flux to product, minimising contaminants and by-products.
Scientist with a fermenter

Chemo-enzymatic Evaluation

Our in house bio- and chemo-synthesis testing capabilities include the following:

  • Design of Experiment (DoE) strategies to define optimal volumetric productivity of synthesis to maximise yield, minimise unwanted impurity or other traits which support manufacturing towards your candidate.
  • Techno-economic assessment of feasible routes combining biocatalytic, microbial and/or chemical synthetic steps.
  • Demonstration of the entire route to your target including upstream and downstream operations.
  • Optional onboarding of customer strain(s) to benchmark growth, viability, productivity and stability potential.
  • Investigation of enhanced product recovery via chromatographic, re-crystallisation, solvent extraction, distillation, reactive extraction, in-situ removal and other approaches.
  • Strain and fermentation engineering, informed by route design, to enhance flux to the target product.
Scientist at hood

Full Process Qualification

  • For fermentation-based products, DoE based study of media, growth and target induction conditions to enhance productivity, yield and recovery of target molecules.
  • Small scale candidate molecule preparation conducted using novel bio- and/or chemo-catalytic conversions.
  • Recovery and purification of target molecules using onboarded or in house developed enhanced protocols.
  • Manufacturing of up to multi-gram quantities of purified target material from process demonstration.
  • Full process study report documentation and recommendations for upstream/downstream process optimisation.
Scientist using AKTA column