With the Covid-19 virus still infecting and claiming lives all across the globe, a vaccine has still yet to be made. But while we wait for laboratories around the world to create one, the government of Malaysia has already identified two local pharmaceutical companies to ‘Fill and Finish’ the Covid-19 vaccine once it is made available.
According to Law Insider, they have defined Fill and Finish as such:
- Formulating the Licensed Product using Drug Substance and other excipients
- Filling the Licensed Product into vials
- Lyophilization of the Drug Substance for incorporation into the Licensed Product
- Testing, including ongoing stability testing, and release of the Licensed Product.
In simple terms, Fill and Finish refers to the bottling and packaging aspects of a vaccine when it has been developed.
Thai researchers plan to begin human trials of a potential vaccine for the new coronavirus in november and are preparing 10,000 doses, a senior official said on sunday, aiming for a vaccine that could be ready for use by late next year. (reuters/dado ruvic/illustration)
Minister of Science, Technology and Innovation Khairy Jamaluddin said that the facilities owned by Duopharma Biotech Bhd and Pharmaniaga should be used for the purpose as agreed by Prime Minister Tan Sri Muhyiddin Yassin, according to Bernama.
This is so that the delivery process of the vaccine will be faster as compared to having the Fill and Finish process completed abroad.
“We will buy from vaccine makers from abroad, whether it be China, the US (United States of America) or UK (United Kingdom)… we will buy in bulk, bring it back to Malaysia and we will bottle it,” Khairy said.
“If we were to wait for the fill and finish process from abroad, it will take a long time, so this is the only option available.”
Khairy added that he has personally visited both the production facilities and found that they had the capacity to carry out the bottling process.
“They are the two companies that have accredited fill and finish capabilities in Malaysia. The Duopharma fill and finish facility is not being used but Pharmaniaga’s is being used. However, they told us they are willing to prioritise COVID-19 when the vaccine is available,” he said.
“If the vaccine is suitable (to be bottled) with the facilities we have… meaning our facilities can fill and finish the inactivated vaccines, so if the successful vaccine is an inactivated one, we can fill and finish it here without a huge investment.”
Meanwhile, he also said that the government is willing to offer the service to other countries.
“For example, we will work with Correlation of Epidemic Preparedness and Innovation to offer our fill and finish facility for other countries that don’t have the facility once we have done it for our people,” he said.
Malaysia is certainly a few steps ahead when it comes to dealing with this pandemic. Before a vaccine is even made available, the government has already identified the pharmaceutical companies that will store it.
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