Process Development

Our biologics process development combines cutting-edge technologies with a strategic, data-driven approach to bring your drug substance to life. Leveraging our expertise in upstream and downstream process optimisation, we deliver robust processes tailored to meet the unique requirements of each project. From precision cell culture and fermentation processes, to tailored scalable product purification, we ensure that every step meets the expected efficiency, predictability, and quality of a biologics production process.

Our expertise with bacterial yeast and mammalian hosts enables us to create high-quality and viable processes that drive reliable scale-up for efficient manufacturing.

You can read more about our expertise and success stories below.

Upstream Process Development

Our USP development services offer a seamless journey from high-throughput parallel bioreactors to scalable culture systems, ensuring optimal cell viability and productivity. With real-time monitoring of critical parameters, we fine-tune each process to deliver consistent, high-quality results.

Our services include:

  • Seamless upstream development path from 250 mL high-throughput parallel bioreactors to optimised 20 L scale glass or single-use culture vessels.
  • Over 10 process parameters monitored throughout, including dissolved oxygen, pH, agitation, aeration and off-gases.
  • Optimal product yield from customised feedstock and feed-regime alongside versatile product induction protocols.
  • Biomass, cell viability and productivity optimised with predictable performance at manufacturing scale.
  • Batch, fed-batch, chemostat and perfusion continuous fermentation processes developed and applied to improve process efficiencies.
  • USP optimisation demonstrated in bacterial, yeast and mammalian cells.
  • Alternating and tangential flow filtration (ATF / TFF) for continuous efficient separation of peptides and proteins from biomass.
  • Full documentation package and comprehensive technology transfer to customer or third-party manufacturer.
Fermenter bubbles

Downstream Process Development

Our DSP is tailored to recover and purify proteins with precision and minimal loss. We have all the capabilities needed to meet your product specifications and ensure high-yield recovery and stability, supporting extended shelf life and simplified Biologics purification.

Our services include:

  • Choice of cell disruption approaches including homogenisation, sonication and chemical lysis.
  • Clarification by batch centrifugation, microfiltration, and ultrafiltration.
  • A full range of ion exchange, multi-modal, affinity, and size exclusion chromatography techniques providing flexible methods for product recovery.
  • Buffer exchange and concentration via scalable micro and ultrafiltration TFF techniques.
  • A range of process scales from small scale production runs (mg scale) up to multi-gram batches.
  • Freeze drying up to 10 L for protein preservation and extended shelf life.
  • Full documentation package and comprehensive technology transfer to customer or third-party manufacturer.
Scientist using AKTA column