Brochure | June 2, 2025

Integrated Solutions For Your Mammalian-Based Biologics

Source: Eurofins
GettyImages-952307842-biobanking-deep freeze-biological sample

A Canadian-based, FDA and Health Canada-approved contract development and manufacturing organization (CDMO) provides comprehensive support for mammalian-based biologics such as monoclonal antibodies (mAbs), biosimilars, recombinant proteins, and antibody-drug conjugates (ADCs). Services span upstream and downstream processing, along with full analytical capabilities to support development from early-stage research through to GMP manufacturing at scales up to 200L.

Capabilities include fed-batch and perfusion upstream processes, chromatography and filtration for downstream purification, and extensive analytical testing covering in-process control, product characterization, and formulation development. The organization places strong emphasis on quality and project management, with more than two decades of experience navigating regulatory frameworks across over 25 global markets.

In the area of ADCs, services extend from linker-payload development to safe handling of highly potent compounds. The CDMO utilizes single-use systems and offers flexible scale-up strategies, supporting clinical and commercial production with batch outputs ranging from 10 mg to 100 g. Additional capabilities include solid-state R&D for drug substance and product, aimed at reducing development risk and enhancing intellectual property strength.

This provider operates with a focus on flexibility, customization, and close client collaboration, serving both emerging biotech firms and established pharmaceutical companies. By offering integrated expertise across biologics, small molecules, and ADCs within a single platform, the CDMO delivers streamlined, de-risked pathways to market. Its mission is to help clients accelerate development and ensure regulatory readiness through reliable, scalable, and high-quality solutions.

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