Biocatalysis

With extensive expertise in enzyme screening, reaction optimisation, and scale-up, we apply natural and engineered enzymes to improve efficiency, selectivity, and scalability in complex API development and manufacturing.

Biocatalysis offers powerful advantages in pharmaceutical manufacturing, including enhanced stereoselectivity, milder condition requirements, and reduced waste.

At Sterling, our 50+ years’ expertise in complex chemistry and partnership-centred approach enables us to rapidly screen enzymes and optimise biocatalytic reactions for full-scale manufacturing. We have successfully screened hundreds of enzymes for our customers to identify optimal candidates, and we have experience in scaling biocatalytic reactions up to multi-tonnes.

Our capabilities in biocatalysis span:

• Rapid, high-throughput enzyme screening and hit identification
• Synthetic route development
• Reaction optimisation and cofactor selection
• Process development
• Analytical method development
• Process optimisation and consulting drawing on 50+ years’ experience as a CDMO
• Capability to work with various enzymes classes and types
• Intermediate and bulk manufacture using biocatalysis
• Experienced in technology transfer
• Scale-up risk assessment and engineering evaluation
• Kilo-scale demonstration batches to verify performance
• cGMP biocatalysis manufacturing up to hundreds of multi-tonnes
• Expert network of specialists ready to support your biocatalysis project
• Flexible IP options

Specialised equipment allows us to conduct high-throughput panel screening at the µL scale and identify active enzymes using colorimetric assays and UV-vis analysis. After shortlisting hits, we perform in-depth analysis using high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry and nuclear magnetic resonance (NMR) spectroscopy to evaluate reaction performance and impurity profile.

From there, we work to refine key reaction parameters including solvent and buffer systems, pH, temperature, cofactor selection and recycling systems, catalyst loading and reaction times, among others. This lays the foundation for a scalable and efficient process.

Scaling biocatalytic reactions can bring risks such as enzyme deactivation from mechanical shear effects, concentration and pH sensitivity, enzyme handling requirements, and more.  To ensure robustness and preparedness for larger-scale manufacturing, we harness advanced modelling software and conduct development using process typical lab equipment and representative models for a thorough understanding of scale-up risks.

After comprehensive optimisation and development, we demonstrate the final process at hundreds of grammes up to the multi-kilo scale to verify process performance and ensure robustness prior to cGMP manufacturing.

Enhanced efficiency

Biocatalysis can support highly selective transformations to reduce overall step count in complex processes.

Purity and yield

Enzymes enable precise synthesis with typically fewer impurities and byproducts, as well as higher yields and enantiomeric excess.

Complex transformations

As enzymes can be engineered or tailored, they can catalyse reactions that are challenging or inefficient to achieve through other approaches.

Environmental sustainability

Biocatalytic reactions typically occur under mild conditions with low energy requirements, while enzymes are a sustainable resource and biodegradable, reducing environmental impact and providing organisations with a greener chemistry alternative.