PHARMANIAGA LifeScience Sdn Bhd (PLS) has just received 200 litres of its first batch of Sinovac COVID-19 vaccine bulk (300,000 doses) for the purpose of process validation (PV) batch manufacturing as part of the registration application requirement by the National Pharmaceutical Regulatory Agency (NPRA).
The vaccines arrived in an envirotainer that kept the temperature between 2°C and 8°C, flown by MASkargo on an Airbus A330-300 from Beijing, China.
Witnessing the arrival of the vaccine at Advanced Cargo Centre here were Senior Minister of Defence Datuk Sri Ismail Sabri Yaakob, Minister of Science, Technology and Innovation YB Khairy Jamaluddin, Minister of Transport Datuk Seri Dr. Wee Ka Siong and Foreign Affairs Minister Datuk Seri Hishammuddin Tun Hussein. Also present was the Chinese Ambassador to Malaysia H.E. Ouyang Yujing.
“The PV batch manufacturing followed by stability study monitoring is critical to complete the registration application to ensure that vaccines are of equal quality even with the change in manufacturing sites from Sinovac to PLS,” said Pharmaniaga group managing director Datuk Zulkarnain Md Eusope.
He also mentioned that Pharmaniaga has already submitted two other 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 its PLS plant.
PLS will F&F the vaccines into vials in a highly sterile clean room environment in full compliance of good manufacturing practice (GMP). Datuk Zulkarnain said 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 GMP compliance to ensure vaccines which is produced by PLS are of the quality required for its intended use.
“Malaysia does not have the facility to manufacture or to F&F any vaccines, until now. The F&F facility will be the first halal vaccine plant in the world,” said Zulkarnain.
In the long term, he said that Pharmaniaga aims to help the nation reduce dependency on imported vaccines by entering into the vaccine venture, which will ultimately contribute to reduce the Government’s yearly expenditure.
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. – Feb 27, 2021
–fotoBERNAMA (2021) HAK CIPTA TERPELIHARA
