by BERNAMA/ FILE PIX
The arrival of Sinovac Covid-19 vaccine marked a historic moment for Malaysia and an important milestone for Pharmaniaga Berhad’s (Pharmaniaga) venture into vaccine manufacturing as it will be the first-ever vaccine to be filled and finished locally.
Pharmaniaga LifeScience Sdn Bhd (PLS), a wholly- owned subsidiary of Pharmaniaga today received the first batch of Sinovac Covid-19 vaccine bulk for the purpose of process validation (PV) batch manufacturing.
PV is part of the registration application requirement by the National Pharmaceutical Regulatory Agency (NPRA).
The 200-litre bulk equalling to 300,000 doses of vaccine, arrived in an envirotainer which preserves the vaccine temperature between 2 to 8 degree Celsius was flown in by MASkargo on an Airbus A330-300 from Beijing, China.
“To date, Pharmaniaga has submitted two applications to the NPRA, consisting of product registration for ready to be administered vials from Sinovac Life Sciences and for the fill and finish (F&F) that will be manufactured in our EU certified PLS plant.
“The PV batch manufacturing followed by stability study monitoring is critical to complete the registration to application to ensure that vaccines are of equal quality even with the change in manufacturing sites from Sinovac to PLS,” said Pharmaniaga’s group managing director Datuk Zulkarnain Md Eusope in a statement today.
PLS will F&F the vaccines into vials in a highly sterile clean room environment in full compliance of Good Manufacturing Practice (GMP).
The PV will start on March 1, 2021 and expected to be completed within 12 days.
NPRA will perform a GMP inspection to verify PLS’s compliance and ensure vaccines produced by PLS are of the quality required for its intended use.
“We are very thrilled with the arrival of this PV batch manufacturing because it brings us a step closer to our vision of manufacturing vaccines in this country. Malaysia does not have the facility to manufacture or to F&F any vaccines until now, and we have been importing all the vaccines used in the National Immunisation Programme.
“Our vaccine roadmap, including the F&F facility and a full manufacturing plant will not only be the first in Malaysia, it will also be the first halal vaccine plant in the world. Many renowned vaccine manufacturers will be involved in the know-how and technology transfer in which Sinovac will participate for two vaccines, InsyaAllah,” said Zulkarnain.
In the long term, he said, besides helping the nation to reduce dependency on imported vaccines, Pharmaniaga’s foray into vaccine venture will help the government to reduce its yearly vaccine expenditure.
It will further help spur the industry growth within the value chain including R&D at universities, clinical trials providers and human capital expertise.
Pharmaniaga and Sinovac have signed an agreement for Sinovac to supply in bulk 14 million doses of its Covid-19 vaccine for PLS to conduct F&F manufacturing at its plant.
The bulk vaccine is a vaccine manufactured in the country of origin and transported in large quantities for filling into an administrable form of vials, ampoules or prefilled syringe vaccines.
PLS will process the inactivated vaccine (or killed vaccine), a vaccine consisting of virus particles that have been grown in culture and then lose disease-producing capacity.
The storage and distribution condition of this vaccine is between 2 to 8 degrees and proven to be very reliable and dependable as the technology was established more than 40 years ago.
The vaccine is also ready to use and requires no dilution, unlike some other Covid-19 vaccines in the market.
“Our vaccine roadmap, including the F&F facility and a full manufacturing plant will not only be the first in Malaysia, it will also be the first halal vaccine plant in the world.
“Many renowned vaccine manufacturers will be involved in the know-how and technology transfer in which Sinovac will participate for two vaccines, InsyaAllah,” added Zulkarnain.
Pharmaniaga is the leading pharmaceutical company of Boustead Holdings Berhad group of companies, which together with Armed Forces Fund Board, are the major shareholders of the company.