- Recipharm, a global CDMO, has successfully completed cGMP manufacture of PnuBioVax®, a protein-based pneumococcal vaccine developed by ImmBio and iiCON, enabling Phase 2 clinical trials in Malawi.
- The vaccine production followed a seamless technology transfer and included process optimisation, quality control, and scale-up to meet Phase 2 requirements.
Recipharm, a global contract development and manufacturing organisation (CDMO), has delivered the cGMP manufacture of PnuBioVax®, a new protein-based vaccine against pneumococcal disease. This milestone enables the start of Phase 2 clinical trials in Malawi, part of a £3.2 million Medical Research Council-funded study led by the Infection Innovation Consortium (iiCON) in collaboration with the Liverpool School of Tropical Medicine.
PnuBioVax® targets proteins common across pneumococcal strains, including Serotype 3, addressing gaps left by current vaccines. Following technology transfer from the Phase 1 CDMO, Recipharm scaled up production, optimised processes, and implemented rigorous quality control to ensure consistent, high-quality output for Phase 2 trials.
“Supporting iiCON and ImmBio to bring PnuBioVax® into Phase 2 cGMP clinical supply is a testament to the strength of collaborative science and manufacturing excellence. We are proud to contribute to a project that has the potential to save lives and reduce the global burden of antimicrobial resistance.”
Vikas Gupta, President of Recipharm Advanced Bio
The Phase 2a trial in Malawi involves approximately 400 participants and builds on the established CHIM model for pneumococcal disease. The trial aims to assess the vaccine’s safety, immunogenicity, and potential to provide broad, cost-effective protection against multiple serotypes, informing future larger-scale trials and potential commercialisation.
Professor Janet Hemingway, iiCON’s founding director, emphasised the collaborative effort: “Our team has worked closely with ImmBio and our manufacturing partner, Recipharm Advanced Bio, to overcome R&D hurdles and enable a smooth tech transfer process to bring this vaccine forward and into clinical trials at our specialist testing facility in Malawi.”
