Why India Needs To Locally Develop Critical Raw Materials For Vaccine Production

Indian pharmaceutical company Bharat Biotech and top vaccine maker Serum Institute of India (SII) has been facing challenges after the United States and Europe banned the export of critical raw material required to produce vaccines.

Shortage of crucial production inputs, including single-use bioreactor bags, beta propiolactone and thimerosal are threatening to scale down companies’ ambitious production targets.

The production of Covid-19 vaccines, including Covaxin and Covishield, as well as scaling up global availability could be limited due to such export restrictions.

At a time when India, as well as the entire world, need more Covid-19 vaccines, SII Adar Poonawalla has urged authorities to look at the current situation related to material shortage.

At an event organized by the World Bank, he said that there are a lot of bioreactor bags, filter and other critical items that vaccine manufacturers need.

“The Novavax vaccine that we are a major manufacturer of, need these items from the US...Now the US has chosen to invoke the Defence Act, in which there is a sub-clause which prevents the export of critical raw materials required for their local vaccine manufacturers," he explained.

The act gives the US President the power to mobilise domestic industry so that the supply of essential materials and services is maintained for national defence purpose.

As per Poonawalla the invocation of this act to preserve vaccine raw materials for its own companies went against the global of sharing vaccines equitably.

In terms of importing raw material, China is an option but it is not reliable enough due to quality issues.

Crucial Vaccine Production Items

In recent years, single-use disposable plastic bag bioreactors have become more popular compared to multi-use stainless steel bioreactors. These are used for cell culture and fermentation.

The cell culture media are an important part of the mass production of inactivated virus-, viral vector- and protein subunit-based Covid-19 vaccines.

The single-use bioreactors are a cheaper investment and available in lower volumes, allowing vaccine manufacturers to test different cell lines and growth conditions quickly, as well as at a lower cost to optimise the production.

The prominent players for the global single-use Bioreactor Market are Sartorius Stedim Biotech (France), Applikon Biotechnology B.V. (Netherlands), Thermo Fisher Scientific (US), Danaher Corporation (US), Xcellerex (US), PBS Biotech (US) Merck Millipore (Germany) and Eppendorf (Germany).

Beta Propiolactone (BPL) is another chemical component that is commonly used as an inactivating reagent to produce viral vaccines.

To create Covaxin, Bharat Biotech used a sample of the coronavirus isolated by India’s National Institute of Virology, in Pune.

After producing the large stock of viruses, the makers doused them with beta-propiolactone, which can disable the coronaviruses by bonding to their genes.

Another important material is ‘Thimerosal’ which is a mercury-containing organic compound.

This has been in use since the 1930s to produce several biological and drug products, including many vaccines.

This is a preservative and contains mercury. It can prevent the growth of life-threatening harmful bacteria.

Beta-propiolactone and thimerosal both are being imported from Germany, while other raw materials from the US.

Poonawalla said that the issues with the imports from the US need some discussion with the Joe Biden-Kamala Harris administration.

"We are talking about having a free global access to vaccines but if we can't get the raw materials out of the US, which a lot of manufacturers, not just Novovax that needs, that's going to be a serious limiting factor for other manufacturers to scale up," he said as reported by the Economic Times.

In the wake of a shortage of raw materials to produce Covid-19 vaccines, Bharat Biotech International—along with Bengaluru based Biovet Private Ltd and Sapigen Biologix in Hyderabad—has recently announced that it has tied up with the Council of Scientific and Industrial Research (CSIR).

The motive behind this collaboration is to make India self-reliant in manufacturing raw materials required to produce vaccines.

Through this joint effort, the companies will work together on technologies and platforms for novel vaccines, drugs as well as raw materials, which are often in shortage.

The collaboration is also considering platforms such as mRNA.

According to Shekhar Mande, director-general of the CSIR, the mRNA technology has proven to be a powerful platform during the Coronavirus pandemic.

He said: “India must have an mRNA platform, and in the coming few months, we should be able to bring this here,”

If the vendors, labs, equipment makers, distributers of necessary chemical compounds, everything comes under one roof in India then the reliability on other countries will no longer be a factor.

So, probably this shortage of materials appears as a wake-up call to look at the possibilities in India.

Acknowledgment - Twitter User https://twitter.com/daeroplate_v2/status/1382320413179473921