REPROCELL and BioBridge Global sign Memorandum of Understanding to accelerate global manufacturing services using clinical iPSCs

Biomanufacturing Services

Our Objective is Your Success

GenCure is a full-service biomanufacturing organization that collaborates with clients to deliver comprehensive, cell and cell-based manufacturing solutions. Leveraging its showcase facility designed to be compliant with FDA, EMEA, and PMDA production requirements, GenCure focuses on translating and refining early-stage processes to scale for commercial readiness.

GenCure is the anchor tenant at the VelocityTX
Innovation Center in San Antonio.

GenCure’s 2,600 SF Process Development Lab offers a comprehensive range of in-house analytical testing services, custom assay development, cell isolation and selection through optimization and scale-up to 80L bioreactor.

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GenCure’s cGMP 6,700 SF cleanroom production space is sized for a wide range of production volumes up to a series of 250L bioreactors. Cleanrooms are designed to be compliant with U.S., European and Japanese regulations.

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Integrated Quality Management System

GenCure leverages the BioBridge Global enterprise quality management system and electronic batch records (EBR) to provide our clients phase-appropriate support. Our experienced team of regulatory and compliance experts interact with governmental agencies, support submission processes, and provide CMC-relevant content to ensure a smooth transition from pre-clinical and clinical evaluation to commercialization.

Our organization complies with numerous U.S. and international standards including International Organization of Standardization (ISO) 9001:2015. View our certifications here

Commitment to Quality

Quality has been a guiding principle within BioBridge Global for almost 50 years.

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