Development services
Production processes ready for manufacturing
Choose Biodextris for your rapid delivery of robust and reliable production processes, ready for manufacturing of your vaccine or biologic.
Development services
Upstream Fermentation
We aim to identify and control the key process parameters that will provide your product with the optimal set of critical quality attributes.
Downstream Purification
We will help you develop, assess and optimize a downstream purification strategy to isolate your product.
Process Transfer
Our expertise helps our clients contain costs, manage risk and maintain key process knowledge, by employing a systematic approach to process transfer.
Process Development
Biodextris is an expert in accelerating our client’s projects from the bench to the clinic. We efficiently deliver robust and reliable production processes ready for manufacturing a wide array of vaccines and biologics.
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
Monoclonal antibodies
Our clients span the globe as well as sectors from agricultural applications, to diagnostics and of course our cores in human health-based biologics and vaccines.
Throughout the execution of our process development strategy, our analytical services team develop appropriate assays to ensure your product is properly characterized and enumerated accurately, insuring the product meets or exceeds your expectations. Click here for more details about our Analytical Method Development.
Upstream Fermentation
Biologics are produced via a variety of methods and all sorts of microorganisms (bacteria, yeast, fungi and eukaryotic cells), and at Biodextris, we are experts with many of the species used in industry. From the beginning, we aim to identify and control the key process parameters that will provide your product with the optimal set of critical quality attributes.
Biodextris can be your guide navigating through the following activities in establishing an upstream process:
Media evaluation
Media evaluation
Host strain evaluation
Cell line development
Development of batch or fed-batch protocols
Product optimization strategies (yield increase, reducing undesired product)
Analytical parameters
We develop your upstream process using industry leading pilot-scale fermenters and bioreactors. Our systems are interfaced for continuous monitoring, control and data acquisition of temperature, pH, agitation, airflow, pressure, dissolved oxygen, exhaust gas (O2/CO2) and nutrient feeds all in a GMP cleanroom environment where applicable.
Downstream Purification
Many see downstream purification as a mixture of art and science, however, at Biodextris we make it science! We have extensive experience separating our clients’ target products from complex matrices by developing, assessing and optimizing a downstream purification strategy. With our expertise and equipment, we effectively isolate your product while preserving its identity, purity, potency and homogeneity. Our comprehensive analytical group work in tandem to ensure all these parameters are properly analyzed and documented.
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
At Biodextris, we can supply material for early stage clinical trials, but with a client’s success come larger scale needs. Our team is well equipped to transfer your production process to a large-scale partner cGMP facility. We have extensive experience with small and medium sized biotechnology companies, large pharmaceutical and large vaccine manufacturers, government organizations and CMOs. Biodextris is truly an international organization having a well-versed multicultural team and clients across Canada, USA and Europe and Asia.
Our expertise helps our clients contain costs, manage risk and maintain key process knowledge.
We employ a systematic approach to process transfer that includes the following: