Lead and clone selection

Intelligent and targeted lead and clone selections are unquestionably important fundamentals during the development of biologics or biosimilars as they have an immense impact on the development time and thus on the associated costs of the project.

The first stage of selection focusses on a detailed evaluation of suitable lead molecules that have the most desirable properties with respect to high efficacy, low toxicity, as well as suitable pharmacokinetics.
For an economically optimized production of these selected lead candidates, it is essential to select the most promising clones in the further course of drug development, which show consistently high product yields and qualities. Factors such as impurities caused by host cell proteins (HCPs), glycosylation patterns or other post-translational modifications of the protein-based drugs are fundamental critical quality attributes (CQAs) to characterize the functionality, immunogenicity and overall safety of the product.

Biofidus offers a holistic and state-of-the-art analytical service platform for a high-throughput screening of your lead molecules in order to accelerate the development of your biologic or biosimilar.

In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your drug substance (DS), its individual formulation matrix and your distinct analytical question.

Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.