The Health August/September 2020 | Page 18

18 The Health | august-September, 2020 | Industry | Duopharma’s vaccine bottling advantage It is the sole company in the country with an accredited fill-and-finish line dedicated to human vaccines BY KHIRTINI K KUMARAN When it comes to bottling and packaging injectable vaccines, four companies in Malaysia have fill-and-finish line facilities. They are, Kotra Pharma (M) Sdn Bhd, Pharmaniaga Holdings Berhad, YSP Southeast Asia Holding Berhad and Duopharma Biotech Berhad. However, of the four, only Duopharma Biotech has an advantage in that it already has an existing fill-and-finish line dedicated solely to human vaccines which is also accredited. The other three do mostly fill-and-finish process for standard pharmaceutical injections such as penicillin. Thus, the lines are not compatible with human vaccines bottling and packaging. These three companies will require to repurpose and convert their existing line facility to accommodate the fill-and-finish process for human vaccines, which would take some time. They will also need to get them accredited. Moreover, Duopharma Biotech’s existing line dedicated to human vaccines is currently not utilised. In case a successful Covid-19 vaccine is developed, the company can start the fill-and-finish process almost immediately. The fill-and-finish process is one where the active agent of a pharmaceutical product is mixed into its final form (like liquid or powder) and filling and sealing it into final containers (like prefilled syringes or vials). “We are the only company that has a dedicated facility for fill-and-finish that has been accredited by the regulatory body for a human vaccine,” Duopharma Biotech Group Managing Director Leonard Ariff Abdul Shatar told The Health. The listed company is also the most experienced in halal vaccination. According to Leonard Ariff, it has been working on halal vaccines for almost 10 years. He adds: “We are working with different partners with different successes. In fact, at the moment we are working with the US government on halal meningitis vaccine. We believe there is a global market for it. On the issue of halal, he said it would be easier to manage the halal concerns if the manufacturers focused on the manufacturing process. If they were to do the fill-and-finish as well, they would need to use a multi-line and therefore risk contamination. “Hence, we set up the fill-and-finish facility in Malaysia to avoid such contamination. We can bring the vaccines here and do the fill-and-finishing.” Capacity Duopharma Biotech’s facility is designed for the local domestic market, and its fill-and-finish capacity is approximately 12 million vials per year. Will this be sufficient for the Malaysian population? “It depends on the dosage level of the vaccine,” said Leonard Ariff, explaining that some vials can inoculate only one person while others can inoculate 10 people. “Therefore, if one vial can inoculate 10 people, then the 12 million vials could inoculate 120 million people, which is more than sufficient to cater to our population. “As I understand, the Malaysian government is in contact with various companies around the world for potential vaccines.” During the Dewan Rakyat questionand-answer session on July 28, Science, Technology and Innovation (MOSTI) Minister Khairy Jamaluddin disclosed that Malaysia was talking to China about vaccine development by companies and institutions. Taking into account halal considerations Leonard noted that many Chinese vaccine manufacturers were way ahead in the process of developing potential vaccines. “We have suggested to the Malaysian government that they should prompt the manufacturers of potential vaccines to take halal into consideration.” The Covid-19 virus, which first emerged in late 2019, has about 15 mutated strains, and it is a long shot to have a vaccine that will protect us against all 15 mutations of the virus. Leonard Ariff cautioned: “We need to be cautious. Comparatively, at the moment, dengue has five mutated strains, and we have no vaccine for it. “The prospect of having a vaccine to Therefore, if one vial can inoculate 10 people, then the 12 million vials could inoculate 120 million people, which is more than sufficient to cater to our population. As I understand, the Malaysian government is in contact with various companies around the world for potential vaccines.” – Leonard Ariff protect against all 15 mutations is slim. We are more likely to have a successful vaccine which would cover one or two mutations,” he said, adding that the public will need to learn to live with the virus by embracing the new normal. Vaccines are essential only if there is a successful one developed. In the meantime, the priority is to ensure the supply of standard anti-viral medications is sufficient to manage the disease. “All deaths are occurring at stage four and five. It is best to manage the disease so that it does not progress to more severe stages where patients would need oxygen support and be intubated. Buoyant share price Amidst the Covid-19 pandemic, Duopharma Biotech’s business performance continues to grow. It has maintained its position as the leading pharmaceutical company in Malaysia in terms of sales volume and second in terms of sales value. Its shares have also been doing well especially with the recent announcement that it is one of two companies identified by the Malaysian government as having the capacity to undertake the Covid-19 vaccine bottling once a vaccine is developed. Its shares have soared from below RM2 before the announcement on July 14 to above RM3 as of Aug 5. The government had identified Duopharma Biotech and Pharmaniaga for the fill-and-finish bottling. — The Health