Bioneeds India Private Limited

Bronze Sponsor

BIONEEDS India, part of the Veeda Clinical Research, is an established preclinical and bioanalytical CRO with US FDA Audited and OECD GLP Certified facilities. Over the years, we have completed 8500+ GLP studies for regulatory submissions and our expertise lies in development of vaccines, peptides, biologics, biosimilars. and NCEs. We have worked with vaccines for Pneumococcal (23 strains), Hexavalent, Typhoid conjugate, Malaria, Hepatitis A, Hepatitis B, Rubella, Influenza, Rabies, Measles, COVID19 and are well equipped to work with other modalities/diseases. Capabilities include: PRECLINICAL • Evaluating safety, immunogenicity of various vaccines in different animal models • Adjuvant toxicity assessment • Batch release assays with CoA (Specific activity, reactivity, safety, Organ distribution, etc.) BIOANALYTICAL • Bioanalytical method development, method validation and sample analysis (NAb) under GLP and GCLP compliant practices and as per US FDA, EMA guidance • Flow cytometry based Th1, Th2, Th17 cytokine responses and surface marker responses (CD4+/CD8+ ratios) • ELISpot (IFN-γ, other cytokines; Single or Multiplex format (upto 7 cytokines)) • Clinical sample analysis • In-vitro vaccine efficacy evaluation using isolated Human PBMC’s • In-vitro cell-based assays using inactivated viral particles • Pseudovirus neutralization assay Clinical trials are supported through our principal company Veeda Clinical research.