Arrival of Sinovac vaccine an important milestone for Pharmaniaga's vaccine manufacturing venture

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.

"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.

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.

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.

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 andproven 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.

"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.