A biotechnology startup developing an innovative biodegradable polymer-based combination product partnered with Synergy Bioscience to overcome the technical and manufacturing challenges required for clinical development. The product was designed to deliver a small-molecule therapeutic directly to a tumor-bearing organ. As the polymer gradually biodegrades, the drug is released locally, with the goal of reducing the need for systemic treatments such as chemotherapy and radiation. Although the client had a promising technology, they lacked the infrastructure needed to manufacture clinical trial material. Key challenges included: access to GMP-ready cleanroom facilities, qualification of manufacturing equipment, chemistry and microbiology testing, and scientific and technical development support. Without these capabilities, the program could not efficiently progress toward clinical manufacturing. Synergy Bioscience provided an integrated development solution that included: chemical characterization of the product, microbiology testing, cleanroom space for clinical batch manufacturing, qualification of client-supplied manufacturing equipment, chemistry and microbiology testing for clinical trial material, and scientific consulting throughout development. By combining laboratory services with manufacturing infrastructure, the client was able to continue development without waiting for completion of its own facility. With Synergy Bioscience’s support, the client successfully advanced its combination product from early development to Phase 3 clinical readiness. Today, the company is constructing its own manufacturing facility and working with the FDA toward product approval. This engagement shows how Synergy Bioscience can help clients overcome development bottlenecks, support clinical manufacturing activities, and advance innovative products toward major milestones. For sponsors working on complex products, especially those navigating early clinical manufacturing and testing requirements, the right development partner can make the difference between delay and progress. If your team is developing a product that needs development support, chemistry, microbiology, molecular biology testing, and regulatory consulting, Synergy Bioscience is ready to help you move forward with confidence.
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