The journey from translational discovery to approved biotherapeutic can be costly, complex, and carries risk—along with significant reward. Understanding what to expect, where to find support, and discovering startup resources can prepare the path for emerging biotechnology companies. Our Process Solutions division is dedicated to working alongside you on each step of your drug discovery quest. Learn how we can help at every new inflection:
Let us help you identify sources for the funding you’ll need to test and confirm your therapeutic candidates, and advise you regarding patent and other intellectual property issues to protect your success.
Preclinical safety and efficacy testing includes evaluation in vitro and in animal models before candidate compounds can proceed to human trials. New sources of capital are required to conduct toxicology studies and to prepare for manufacture. We can help you identify processes and resources for preparing and filing your Investigational New Drug (IND) application.
After filing your IND the work really begins as you move your candidate into humans. From initial Phase I safety studies to Proof of Concept and Pivotal studies through Phase II and Phase III, we offer process optimization, scale-up and technology transfer/facility design services to prepare you for transitioning from preclinical to clinical to commercial production.
Whether manufacturing clinical trial batches or commercial production, your manufacturing process must meet the same high standards as your R&D and clinical trials. We can help you through the many considerations in the manufacturing phase including Regulatory compliance, Engineering optimization, Single-use manufacturing, and whether to pursue your own 12-20k bioreactor process or leverage a CMO/CDMO.