Biomanufacturing Services

Optimizing Cost, Timing, and Outcomes

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.

End-to-end Capabilities

Access to cGMP and cGTP products for transfusion and transplant; cGMP for further manufacture in development selectively

  • Perinatal tissues
  • Umbilical cord blood 
  • Blood components
  • Bone marrow-derived stem cells
  • Apheresis derived progenitor cells
  • Mononuclear cells

Transfer, development and optimization of cGMP-compliant scalable processes

  • Cell therapy process development
  • Cell isolation
  • Cell expansion
  • Scale-up
  • Downstream purification
  • Formulation development
  • Cryopreservation

cGMP-compliant, phase-appropriate, manufacturing of advanced therapies

  • Pre-clinical
  • Early phase clinical-grade
  • Late phase and commercial
  • Fill/Finish
cGXP testing services performed internally and through qualified partners
  • Sterility testing (ID and susceptibility)
  • Viral safety testing
  • Cell characterization and authentication
  • Potency testing
  • Cell viability
  • Identity/purity testing
  • Custom assay development
  • Method suitability
  • Lot and final product release testing
  • Plasma, blood, cord blood, tissue and organ donor safety testing
Learn More

Management of cold chain processes for final products

  • Optimization of controlled-rate freezing 
  • Storage of products (LN2 vapor-phase, 2-8°C, -20°C, -80°C)
  • Validated shipping procedures
  • Continuous temperature monitoring during shipping
  • Maintenance of samples for stability testing

Quality

Quality

Unified Quality Management System

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).

Commitment to Quality

Quality has been a guiding principle within our organization for more than 45 years.

Commitment to Quality

Quality has been a guiding principle within our organization for more than 45 years.

Biomanufacturing Facilities

Pilot-Scale Facility

GenCure opened its pilot-scale facility in January 2018. This facility includes 2 cleanrooms and a process development lab, compliant with FDA regulations.

Clinical-Scale Facility

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.

 

READ MORE

Biomanufacturing Facilities

Pilot-Scale Facility

GenCure opened its pilot-scale facility in January 2018. This facility includes 2 cleanrooms and a process development lab, compliant with FDA regulations.

Clinical-Scale Facility

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.

 

Read More

Latest News

Industry
October 13, 2020
QualTex Launches Cellular Therapy Testing Services
Lab to support researchers developing new treatments for global healthcare market QualTex Laboratories, a subsidiary of San Antonio-based nonprofit BioBridge Global, has expanded its offerings to include cellular therapy testing […]
Industry
October 8, 2020
GenCure joins with Sentien Biotechnologies, Rooster Bio on $2.4 million contract
Partners will develop potency assay for mesenchymal stromal cells The federal Medical Technology Enterprise Consortium (MTEC) has identified the need for potency testing as critical to new cellular therapies. Sentien […]

Latest News

Industry
October 13, 2020
QualTex Launches Cellular Therapy Testing Services
Lab to support researchers developing new treatments for global healthcare market QualTex Laboratories, a subsidiary of San Antonio-based nonprofit BioBridge Global, has expanded its offerings to include cellular therapy testing […]
Industry
October 8, 2020
GenCure joins with Sentien Biotechnologies, Rooster Bio on $2.4 million contract
Partners will develop potency assay for mesenchymal stromal cells The federal Medical Technology Enterprise Consortium (MTEC) has identified the need for potency testing as critical to new cellular therapies. Sentien […]
Contact Us
For additional information about our products and services.
Certifications
Our organization complies with multiple U.S. and international standards. A full list of accreditations, certifications and registrations can be found here.