Small contract manufacturers wait to take a shot at Covid vaccines

A host of lesser-known vaccine makers are eyeing contract manufacturing opportunities for global and domestic majors

As India, the world’s vaccine factory, gears up to produce more Covid-19 vaccines — both indigenous and foreign — the stage is set for the smaller contract manufacturers to step in. Foreign vaccines such as Moderna and Pfizer-BioNTech’s mRNA vaccines are expected to enter India, but the government has indicated that it would expect that these vaccines would be eventually manufactured here.

Does India have the capacit­i­es and the expertise to make these vaccines based on new technology?

“India has enough fill and finish capacities, and there are several players such as Indian Immunologicals or even Lupin, which have evinced interest in fill-finishing mRNA vaccines. The challenge is in making the drug substance,” said an Indian vaccine maker requesting ano­nymity. Drug substance is the raw material needed to make the vaccine formulation and contains the viral antigen.

As for the mRNA vaccines, homegrown Gennova Bio­phar­ma, which is developing a candi­date based on this technology, is itself looking for contract man­u­­­facturing partners. Biological E is gearing up to make 600 mill­ion doses of Canada’s Provi­de­n­ce Therapeutics mRNA vaccine.

India, which accounts for 60 per cent of the world’s vaccine production (by volume) and supplies 60-80 per cent of the Uni­ted Nations’ annual vaccine procurement, has been ramping up its vaccine capacity since 2020. A quick review shows that most of the big players — Serum Ins­titute of India (SII), Biological E, Indian Immunologicals, Wock­hardt — have drawn up production plans for the next one and a half years and may not have much capacity to spare unless they expand.

Enter the smaller contract manufacturers — Hester Bi­osci­e­nces, Virchow Biotech, Premas Biotech, Shilpa Medicare, Bril­liant Biopharma and the public sector units like Biologicals Corporation Limited (Bibcol) and Haffkine Biopharma.

Gurugram-based Premas Bi­o­­tech does not rule out discu­s­s­ing opportunities for manufact­uring for others, said Co-founder and Managing Director Prabu­d­dha Kundu. Interestingly, it is exploring partners­hips for its own triple-antigen Covid-19 vaccine candidate that is set to start phase 1 clinical trials.

“We have significant production capacity of millions of doses, but are also exploring partners for enhancing our number of av­ailable doses. We are focused on the work we have in hand at the moment. Once completed, we could discuss opportunities in the future,” Kundu told Busi­n­ess Standard, adding that Pre­m­as has a microbial facility for early stage clinical manufacturing.

Ahmedabad’s Hester Bio­sci­ences has already signed a mem­o­randum of understanding with Bharat Biotech for manufacturing the intermediate drug substance for the latter’s Covid-19 vaccine Covaxin. In a post-earnings call, the animal vaccine player’s CEO and MD Rajiv Gandhi told analysts that the company is planning to manufacture anywhere between 5 million and 15 million doses a month of the intermediate substance for the vaccine.

For this, it is also investing around Rs 40 crore towards setting up a Biosafety Level 3 plant that may come handy in future for other similar opportunities.

Some of these smaller players have high-end manufacturing facilities too. Players like Brilliant Biopharma, a Hyderabad-based contract manufacturer, have Bio­­safety Level 3 facilities available. “The company has fully automated bio-reactors and Biosafety Level 3 containment manufacturing facility,” said an industry insider. Brilliant Bio­pharma could not be immediately reached for a comment.

BSL refers to biological safety levels. Laboratories are categor­ised into four levels ranging from BSL-1 to BSL-4 depending on their abilities to handle dangerous and potentially lethal patho­gens. This assumes significance in the context of the pandemic because Bharat Biotech is facing challenges in scaling up production of Covaxin, which requires Biosafety Level 3 facilities.

Russian vaccine maker Sput­nik V was early to spot the oppor­t­unity in India — it has lined up production of more than 1.1 bill­ion doses of its vaccine here. Bes­i­des a range of small players such as Virchow Biotech, Shi­lpa Medi­care, Panacea Biotec, Hete­ro, Gla­nd Pharma and Stelis Bio­p­h­a­rma (a Strides arm), the Ru­s­s­­i­ans have a contract manu­f­ac­t­ur­ing deal with the world’s la­­­­­r­g­e­st va­­­c­cine maker, SII, earlier this week.

SII will make 300 million do­ses of Sputnik V annually. It is making around 1.2 billion doses of the AstraZeneca vaccine ann­ually, and has plans to double that (if it sees demand) in 2022. This is over and above the Coda­genix and Novavax vaccines that SII will make. The non-Covid-19 vaccines (SII made 1.5 billion doses in FY19-20) will continue. Company sources indicate if things go well, SII’s total vaccine production would cross 4 billion annual doses by the end of 2022.

Though large vaccine makers are on expansion mode, there would not be much spare capacity for contract manufacturing. Hyderabad-based Biological E will make around 2 billion vacc­ine doses, including 600 million doses of an mRNA candidate in 2022. Mumbai’s Wockhardt aims to make 2 billion Covid vaccine doses (apart from 500 million doses of the drug substance or API) in the next one or two years.

Ramping up and adapting to new tech to make vaccines is, however, not easy. Sharvil Patel, MD of Zydus Cadila, explained, “The process of manufacturing is very sensitive and complex. Minor changes in the process can change the product outcome. It is very important to know every nuance of a particular vaccine’s manufacture.”

A case in point is Sputnik V production in India. While partnerships were forged by late 2020, Sputnik V from Indian sites is not yet available.

The government has activated several units for making the indigenously developed Cova­x­in. For example, Mumbai’s Haff­kine Biopharmaceuticals is rea­d­ying a Biosafety Level 3 facility in the next eight months to ma­n­ufacture 228 million doses annually of Bharat Biotech’s Co­vaxin. Sandeep Rathod, MD, Haffkine, said, “We have been given a timeline of eight mo­nths and the work is being ex­ecuted on a war footing. The vaccine production process in­volves two stages — drug subs­t­ance and final drug product. For production of drug substa­nces we need to build a Biosafety Le­vel 3 facility, while Haffkine alre­ady has the fill finish facility,” said the doctor-turned-bureaucrat.

Similarly, reports suggest, Bulandshahr-based Bibcol is gearing up to make 10 million Covaxin doses a month starting September, a target most industry insiders feel is not achievable. The unit, which produces 60 per cent of India’s polio vaccines, is now working round the clock to set up a Biosafety Level 3 plant. Indian Immunologicals will make drug substance for 10-15 million doses of Covaxin per month soon and is enhancing its viral vaccine making capacity by 35 per cent by October 2021.

Vaccine contract manufacturing, however, is a major opp­ortunity worldwide now. The global vaccine contract manu­f­ac­turing market is anticipated to value $4 billion by 2026, ex­p­a­nding at a compound annual growth rate (CAGR) of 13 per cent between 2021 and 2026. A Rese­arch and Markets report suggests that the vaccine contract manufacturing market in India is expected to grow at a CAGR of over 15 per cent bet­ween 2020 and 2026.