Our cell-line, upstream, and downstream development processes combine to ensure you receive a well-characterized biologic with consistent product quality.
Our Manufacturing Team works closely with Process Sciences, Quality, Supply Chain, and Product Sponsor to successfully transfer processes from Lab-scale to Manufacturing-scale.
We are collectively responsible for the quality of the products we produce. We deliver on our commitments to provide uncompromised compliance, deliver high-quality products to patients, and achieve the key time-sensitive milestones that drive our clients’ successes.
Our cGMP facilities in Orange County, California houses manufacturing space dedicated to mammalian cell culture and is able to produce both clinical and commercial biologics.
Our analytical methods development group offers extensive experience in transferring, developing, qualifying, and validating client assays.
Our regulatory team has extensive experience in helping clients develop the regulatory strategy and approach, including drafting responses and assisting in formulating strategies for interactions with regulatory authorities.
Our project management team has extensive experience in multiple technical fields, enabling them to drive your project planning and timeline development at every stage.
We are committed to improving the quality of life for people suffering from life threatening diseases through the development of targeted therapeutics for the treatment of cancer and viral diseases. Driven by integrity, teamwork, and innovation, our team is working to deliver on this mission.
Find out how our services can move your products from concept to commercial success.