News
Developing affordable monoclonal antibodies for LMICs through high performance manufacturing processes and LMIC based commercial manufacturing
September 14, 2026 - CSIR-Biomanufacturing, Council for Scientific and Industrial Research, Pretoria, South Africa; Wadsworth-Laboratory of Microbial Pathogenesis and Immunology (MPI) Division of Infectious Diseases, Wadsworth Center, Albany, NY, United State; ServareGMP, San Diego, CA, USA 
Monoclonal Antibodies (mAbs) are one of the most effective developments in disease prevention and treatment of the last century. Active treatment and passive immunization with mAbs targeting key antigens represents a promising approach to preventing and mitigating infectious pathogen-caused illness, particularly in Low and Middle-Income Countries (LMICs). While the development of mAbs against infectious disease has lagged behind that of immune disorders and oncology targets, recent efforts against infectious diseases have seen increasing focus with the development of mAbs against RSV, Ebola strains, and SARS-CoV-2, among others. The price for mAb treatment remains out of reach for most patients in middle income countries and nearly all patients in low-income countries. It is therefore clear that a new approach to manufacturing mAbs is needed. Here, high-productivity, high-yield mAb fed-batch production is demonstrated using clonal variants of ZAC-3, a mAb directed against the conserved core/lipid A region of V. cholerae lipopolysaccharide (LPS). We then extrapolate production levels seen in the ZAC-3 fed-batch run data to a continuous manufacturing approach to show a potentially viable path to manufacturing low cost mAbs at commercial scale. The reduction in cost of manufacturing drug substance resulting from the use of a continuous manufacturing process, coupled with high efficacy, and potential for low dose sizes, could give mAbs such as ZAC-3 the potential to be widely used in LMICs. The manufacture of mAbs in an LMIC-based commercial GMP facility should further reduce the cost of manufacturing, aiding in providing low-cost mAbs to patients in LMICs. Taken together, we aim to show that the potential for developing deployable antibody-based interventions to combat unaddressed pediatric diseases and rapid outbreak responses in LMICs is within reach.
For further information contact: info@servarebiologics.com
New human trials for novel antibody offer hope for immediate protection against deadly Nipah
July 3, 2024 - Oslo, Norway; San Diego, CA, USA - For Immediate Release
Twenty-five years after the first human outbreak of Nipah virus, a novel Nipah monoclonal antibody—which could offer people at risk of infection immediate protection against the deadly disease—is planned to undergo human clinical trials in India and Bangladesh.
These clinical trials will assess the safety and tolerability of a Nipah monoclonal antibody (mAb), a protein that mimics natural antibodies by binding to the virus and preventing infection, which is designed to protect people in Nipah-affected countries from contracting the disease.
With $43.5 million in funding from CEPI, the human trials are intended to commence in 2025, pending regulatory approval. Led by non-profit biotechnology company ServareGMP and supported by Mapp Biopharmaceutical, the trials will assess the Nipah mAb, MBP1F5, in healthy adults at multiple clinical trial sites in India and Bangladesh—two countries that suffer Nipah outbreaks almost every year.
Funding will also support preclinical studies seeking to expand the use of the mAb from pre-exposure prophylaxis (before someone is exposed to a virus) to post-exposure prophylaxis, that is, for people shortly after infection with the virus.
For further information contact: info@servarebiologics.com
ServareGMP, Wadsworth Center, and Wellcome Trust collaborate on ZAC3, a Novel mAb against Cholera
June 15, 2022 - San Diego, CA - For Immediate Release
ServareGMP and Wadsworth Center, with financial support from Wellcome Trust, are developing an ultra low-cost monoclonal antibody (“mAb”) against Vibrio cholera for use in low resource countries and displaced persons settlements where cholera continues to cause substantial disease and death.
The globe is experiencing its 7th cholera pandemic, with the highest incidence of disease concentrated in regions experiencing natural disasters or civil conflicts. V. cholera is transmitted through the consumption of contaminated water and food, with the spread of disease more pronounced when infrastructures break down. Despite the success of oral cholera vaccination, there remains a need for an effective pre-exposure prophylactic for administration in outbreak situations where vaccine implementation is not possible.
Servare’s mAb, ZAC-3, will mitigate against the most severe manifestations of the disease. ZAC-3 has been engineered with serum half-life extension technology, and manufactured using innovative cost reduction strategies, creating radical improvements over prior mAb performance.
By developing an effective, low cost mAb against a highly challenging disease, Servare and its partners intend to demonstrate that effective mAbs are not restricted to high income countries and can be deployed around the globe to address serious unmet needs in a cost-effective manner.
ServareGMP. Servare was formed as a non-profit, charitable public benefit corporation with the intent of creating highly effective biologic drugs against challenging unmet diseases for free to very low cost than those currently available. Servare utilizes its founders’ expertise in the discovery, development, and GMP manufacturing complex large molecules for use in humans. Augmented through strong partnerships with other experts in the space, Servare is creating new therapeutic and prophylactic proteins, vaccines, vectors and cell therapies for underserved, neglected, and vulnerable populations.
The Wadsworth Center. Wadsworth Center is a science-based community committed to protecting and improving health through laboratory analysis, investigations, and research, as well as laboratory certification and educational programs. Scientists at Wadsworth Center study: ongoing public health issues, from drug resistance to emerging infections and environmental exposures; investigate basic biological processes that contribute to human health and disease; employ modern methods, such as biomarkers of exposure, and state-of-the-art technologies, among them a resource for visualizing biologically relevant molecules.
The Wellcome Trust. Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.
For further information contact: info@servarebiologics.com