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This whitepaper goes through five testing strategies that QualTex Laboratories use to help customers in the cell and cell-based therapy industry.
GenCure enables progress in the field of advanced therapies by offering process and analytical development, cGMP manufacturing, in-process and release testing, while leveraging a unified quality management system.
We partner with our customers with the end goal of clinical development and commercialization in mind.
Access to cGMP and cGTP products for transfusion and transplant; cGMP for further manufacture in development selectively
Transfer, development and optimization of cGMP-compliant scalable processes
cGMP-compliant, phase-appropriate, manufacturing of advanced therapies
Management of cold chain processes for final products
Our in-house quality and compliance staff are experienced in interacting with regulatory agencies and submission processes, providing CMC-relevant content to support submission, and ensuring a smooth transition from pre-clinical and clinical evaluation to commercialization.
GenCure leverages an enterprise quality management system and provides phase-appropriate support to its customers. This allows all services available through BioBridge Global to be governed by the same system.
Our organization is in compliance with numerous U.S. and international standards including International Organization of Standardization (ISO).
GenCure opened its pilot-scale facility in January 2018. This facility includes 2 cleanrooms and a process development lab, compliant with FDA regulations.
The first phase of GenCure’s clinical-scale biomanufacturing facility opened in March 2020 in the heart of San Antonio, at the VelocityTX Innovation Center.
The biomanufacturing space is compliant with FDA regulations, EU Annex 1 and PMDA (Grade A, B, C, D).
Cleanrooms are sized for a wide range of production volumes, up to a series of 250L bioreactors.
This facility includes an initial 6,700 square feet of cleanroom production space, a 2,500-square-foot development lab, along with office and meeting space.
GenCure opened its pilot-scale facility in January 2018. This facility includes 2 cleanrooms and a process development lab, compliant with FDA regulations.
The first phase of GenCure’s clinical-scale biomanufacturing facility opened in March 2020 in the heart of San Antonio, at the VelocityTX Innovation Center.
The biomanufacturing space is compliant with FDA regulations, EU Annex 1 and PMDA (Grade A, B, C, D).
Cleanrooms are sized for a wide range of production volumes, up to a series of 250L bioreactors.
This facility includes an initial 6,700 square feet of cleanroom production space, a 2,500-square-foot development lab, along with office and meeting space.
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