In vivo Safety & Identity Testing of rBCG Vaccine

MULTIPLE TESTING & SAMPLES

We are seeking a GMP/GLP qualified laboratory capable of performing in vivo safety and identity testing on finished recombinant BCG vaccine lots, specifically: In vivo general safety testing in mice and guinea pigs, following legacy 21 CFR 610.11 methodology (withdrawn but still accepted as industry best practice) and aligned with WHO TRS 978, Annex 3 (2013) for BCG vaccines.

These tests should evaluate clinical signs, weight change, and mortality over a 7-day observation period. Freedom from virulent mycobacteria test in guinea pigs, which involves high-dose subcutaneous inoculation followed by 42 days of observation, histopathological examination, and PCR testing for virulence-associated markers (e.g., ESAT-6). This assay must confirm the absence of reversion to a virulent form and rule out contamination with M. tuberculosis.

All testing must be performed in full compliance with GLP (21 CFR Part 58) and demonstrate alignment with current standards for biological product lot release as outlined in 21 CFR and WHO GMP. We require detailed reporting, including protocol approval by an IACUC or equivalent ethical review board, raw data, histological reports, PCR results, and a final signed report certifying the results.

The service provider must have experience with biologicals, preferably with BCG or mycobacterial vaccines, and be authorized to issue reports suitable for submission to regulatory authorities (FDA, EMA, WHO PQ). We would appreciate a technical and regulatory confirmation, along with estimated timelines, documentation requirements, and relevant certifications.