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Process Development

Companies trust us to accelerate their project from the bench to the clinic. We rapidly deliver robust and reliable production processes ready for manufacturing of your vaccine or biologic.

We offer comprehensive process development activities for complex biological products in the following areas;

  • Recombinant purified proteins
  • Cell membrane preparations
  • Complex multi-component systems
  • Whole cell based products

We are differentiated through our experience in applying the techniques of biotechnology toward the commercial development of complex biologicals in a regulated industry.

Cell Culture

Upstream Fermentation

With biologics, the product is inseparable from the production process. We aim from the beginning to identify and control the key process parameters that will provide your product with the optimal set of critical quality attributes.

We will guide you through media evaluation, host strain evaluation, development of batch or fed-batch protocols, process improvement or product optimization strategies as needed to deliver the comprehensive upstream package you need.

We develop your upstream microbial process using industry leading pilot-scale fermenters, interfaced for continuous monitoring, control and data acquisition of temperature, pH, agitation, airflow, pressure, dissolved oxygen, exhaust gas (O2/CO2) and nutrient feeds.

Downstream Purification

Separating your product from a complex biological matrix poses unique challenges. We will help you develop, assess and optimize a downstream purification strategy to isolate your product while preserving its identity, purity, potency and homogeneity.

We will lead you through phase-appropriate activities such as resin screening, chromatographic protocol development, protein compatibility studies, accelerated stability studies, process robustness and pre-formulation testing leading to a comprehensive downstream package ready for manufacturing.

We use industry leading AKTA Avant and Pilot systems for performance of various chromatography methods including ion exchange, hydrophobic interaction, reverse phase and size exclusion chromatography as well as tangential flow filtration and sterile filtration.


Process Transfer

We are well equipped to transfer your production process to pilot and production scale partner cGMP facilities, with previous experience covering small and medium sized biotechnology companies, large pharmaceutical and large vaccine manufacturers, government organizations and CMOs, located in the US, Canada and Europe.

Our expertise helps our clients contain costs, manage risk and maintain key process knowledge, by employing a systematic approach to process transfer that includes control of scale-related process variations, control of equipment related variations, management and execution of transfer lots, and the provision of training, documentation and knowledge management.