DOWNSTREAM PROCESSING FACILITIES Purification Capabilities GTC Biotherapeutics' fully integrated pilot purification facility in Framingham, Massachusetts is designed for the manufacture of bulk drug substance intended for preclinical and human clinical studies. GTC established its capabilities to provide purification of proteins from its transgenic development programs as well as from non-transgenic sources. GTC has extensive experience in external partnerships and has an established culture of flexible collaboration, essential for effective client relationships and successful product development. GTC's downstream processing capabilities enhance GTC's value as a product development and manufacturing partner. Process Development GTC's group of highly skilled and experienced scientists has successfully developed robust, scalable purification processes for a variety of therapeutic proteins. Whether developing a purification process from the beginning or optimizing an existing process for in vitro cell culture starting material, GTC can bring a high level of technical expertise to bear on any protein purification project. GTC recognizes the importance of a fully integrated QA/QC function and has successfully established a quality-oriented approach to all aspects of process development and manufacturing. Manufacturing The GTC purification facility is a 2,500 sq ft, fully functional operation, housing class 100 and 100,000 space for downstream processing. Incorporating gowning, buffer preparation, storage, and parts wash area, our purification facility can support all aspects of a clinical manufacturing campaign with an annual processing capacity of multiple kilograms. External Collaborations GTC's experienced team of professionals understands the business of developing therapeutic biopharmaceuticals on behalf of client companies. GTC's Operations leadership has extensive experience each in bringing products from the bench to commercial approval. GTC's Regulatory experience includes compiling and submitting the world's first transgenically sourced therapeutic product marketing approval application. GTC's dedicated Program Management team ensures a collaborative relationship with a high level of communication with the client throughout the project. Expertise and Experience that Makes a Difference. GTC's experienced scientific team brings high levels of competency to all areas of downstream process development and manufacturing; Analytical development Purification development Process optimization Process validation Process control QA/QC Regulatory Release testing
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