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:
Host strain evaluation
Cell line development
Development of batch or fed-batch protocols
Product optimization strategies (yield increase, reducing undesired product)
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.
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: