Solution Group Berhad’s wholly-owned subsidiary, Solution Biologics Sdn Bhd, the ASEAN manufacturing partner of CanSino Biologics Inc announces that local formulation, fill & finish of the single-dose Convidecia vaccine can now commence at the Company’s fill-and-finish facility after obtaining the Good Manufacturing Practice certification from the National Pharmaceutical Regulatory Agency.
With the GMP certification from the NPRA, SGB’s F&F facility in Technology Park Malaysia is the first F&F facility with local formulation capability. The facility is able to produce up to 3 million vials of vaccine per month, or the equivalent of up to 36 million vials per year.
Dato’ Dr. Mohd Nazlee Bin Kamal, Deputy Group Managing Director of SGB, said, “The certification is an important milestone for SGB as this means that we can formulate the Convidecia vaccine, and the F&F locally as compared to before when we received finished doses from CanSinoBIO and bulk active pharmaceutical ingredient (“API”). This is important too as we are now able to process the API for filling into vials that can be stored in our cold room.”
“This GMP certification will enable us to increase our Convidecia vaccine production for private sales since mid-November 2021 and at the same time to increase the supply of the vaccine to meet demand in Malaysia and the region that is undergoing a surge of infections due to the Omicron variant of COVID-19. We are also working towards obtaining approval from the Ministry of Health (“MoH”) for Convidecia to be used as a heterologous booster for other primary vaccine recipients.”
SOLBIO and CanSinoBIO are also working together to produce an inhaled version of the vaccine. This inhaled version, which induces cellular, humoral, and mucosal immunity, is currently undergoing trials as a booster and is expected to broaden the immune response against COVID-19.
