Development and Manufacturing

Taking biosimilars from concept to IND

Our biosimilar capabilities are designed to help provide patients worldwide with access to the most advanced life-saving and life-improving therapies available. We leverage our large molecule capabilities to develop biosimilars that have no meaningful difference from their reference product in terms of safety and efficacy and are more affordable than the originator drug. We also have extensive expertise in cell line development, PQA modulation and process development to maximize reduce the overall cost of goods during development.

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Technical Development

Our cell line development, process development and analytical development team set the foundation for all our programs. They are the first step in creating our pipeline.

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Manufacturing

We have state of the art manufacturing facilities for both mammalian and microbial manufacturing for clinical for preclinical, clinical and commercial supply, including fill and finish.

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Clinical

Our clinical operations group manages pre-clinical and clinical trials, a lengthy process but critical to ensuring our biosimilars are safe and effective for the patients that need them most.

Let’s collaborate and deliver quality biosimilars together.

Get in touch for more information.