Biodextris services

Biodextris supports you in the design of a suite of analytical assays that assess the important and critical quality attributes for your unique product. Our team of talented scientists follow a systematic structured methodology to develop each assay optimized for your product.

Validation of a method is a critical step of development work. We, at Biodextris, validate your assays to demonstrate that the appropriate performance criteria are met, and the analytical target profile is achieved. Our quality management system ensures validation policies are aligned with the ICH method validation guidelines ICH Q2(R1).

Our clients and their situations are all different and as such Biodextris can offer up a wide array of options when it comes to method transfer. On inward bound method transfers we can take in a method and simply transfer and execute, or if requested, we can offer our expertise to further optimize it. With outward bound transfers we offer full support to help our clients (and their partners) get our new methods up and running with comprehensive documentation and access to our team’s expertise. Quality is our guarantee!

Clinical Drug Substance/Product Analysis: We support you to confidently release your clinical product by executing validated assays which form the backbone of your product monograph or IND CMC section, and establish the quality, efficacy and safety of your product. Our technologies allow complete analysis of bulk drug substance and liquid or lyophilized drug product, and the validated analytical methods are performed under rigorous quality oversight, following defined standard operating procedures. Your data integrity is assured and your results are handled securely.

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.

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.

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.

Biodextris effectively addresses that crucial area from discovery to clinical material. Coupled with both GMP and non-GMP production suites we are able to offer cost effective and compliant product to a wide range of clients. Whether its small scale, early stage or a more mature product destined for the clinic we’ve got you covered. Our manufacturing capacity is in high demand, with purified protein production performed at scales ranging from milligrams to tens of grams per batch.