Manufacturing Strategy Development

Our manufacturing strategy development team will walk you through what needs to be done to keep your project on time, in compliance, and within budget — a crucial first step for every project.

We will discuss how our abilities and expertise will fit with your project to get it through the process development, scale-up, cGMP manufacturing, and regulatory stages for IND filing for preclinical through late-stage clinical trials. This also includes but is not limited to viral clearance studies, product stability, reference standard creation, and other services.

GBI will launch our first commercial products in 2023 on behalf of our clients.

Dr. Nickolay Kukekov; President and CEO of Kalgene Pharmaceuticals
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GBI delivers on their promises and commitments. I would highly recommend them to anyone who needs excellence in CMC manufacturing.

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Dr. Nickolay Kukekov President and CEO, KalGene Pharmaceuticals

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