ServareGMP
ServareGMP is a non-profit biotechnology organization dedicated to developing and manufacturing low-cost biologic medicines for infectious diseases, unmet needs, and neglected diseases affecting vulnerable populations. With extensive expertise in bioprocessing and GMP manufacturing, it collaborates with various partners to bring breakthrough technologies and affordable medicines to populations at risk from outbreaks, bacterial and fungal infections, parasite-caused diseases, and other unmet health needs. The organization aims to increase access to biologics in low-resource settings through innovative manufacturing, partnerships, and seeding biomanufacturing operations in underserved regions.
Industries
Nr. of Employees
small (1-50)
Products
Monoclonal antibody prophylactic against Vibrio cholerae (ZAC-3 program)
A prophylactic monoclonal antibody targeting V. cholerae O1 and O139 LPS, engineered for extended half-life and intended for low-cost subcutaneous administration in outbreak and resource-limited settings.
Monoclonal antibody for Nipah virus (clinical development program)
Monoclonal antibody program intended to provide immediate protection against Nipah virus; advanced toward human clinical trials to assess safety and tolerability.
Monoclonal antibody prophylactic against Vibrio cholerae (ZAC-3 program)
A prophylactic monoclonal antibody targeting V. cholerae O1 and O139 LPS, engineered for extended half-life and intended for low-cost subcutaneous administration in outbreak and resource-limited settings.
Monoclonal antibody for Nipah virus (clinical development program)
Monoclonal antibody program intended to provide immediate protection against Nipah virus; advanced toward human clinical trials to assess safety and tolerability.
Services
On-site development and GMP manufacture of biologic therapeutics across clinical phases and commercial supply.
Upstream and downstream process optimization, scale-up, and formulation development to enable subcutaneous delivery and reduced cold-chain dependence.
Support for preclinical studies and planning/execution of human clinical trials including multinational Phase I safety/tolerability studies.
Open-source, license-free transfer of methods, procedures and equipment to establish local biologics manufacturing operations in LMICs, working with local authorities and NGOs.
Development of high-performance cell lines and creation of GMP master and working cell banks for various expression systems.
On-site development and GMP manufacture of biologic therapeutics across clinical phases and commercial supply.
Upstream and downstream process optimization, scale-up, and formulation development to enable subcutaneous delivery and reduced cold-chain dependence.
Support for preclinical studies and planning/execution of human clinical trials including multinational Phase I safety/tolerability studies.
Open-source, license-free transfer of methods, procedures and equipment to establish local biologics manufacturing operations in LMICs, working with local authorities and NGOs.
Development of high-performance cell lines and creation of GMP master and working cell banks for various expression systems.
Expertise Areas
- Bioprocessing and GMP manufacturing
- Cell line development and cell banking
- Process development and scale-up
- Formulation development and delivery route optimization
Key Technologies
- Single-use bioprocessing
- Fed-batch and concentrated fed-batch bioreactors
- Continuous perfusion
- Continuous purification
News & Updates
Clinical trials planned in India and Bangladesh to assess safety and efficacy of Nipah monoclonal antibody MBP1F5, supported by $43.5 million funding from CEPI.
Collaboration with Wadsworth Center and Wellcome Trust to develop an ultra low-cost monoclonal antibody ZAC-3 for cholera in low-resource settings.
Clinical trials planned in India and Bangladesh to assess safety and efficacy of Nipah monoclonal antibody MBP1F5, supported by $43.5 million funding from CEPI.
Collaboration with Wadsworth Center and Wellcome Trust to develop an ultra low-cost monoclonal antibody ZAC-3 for cholera in low-resource settings.