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Biological E -- India's next Serum, Bharat Biotech of COVID-19 vaccine

Biological E -- India's next Serum, Bharat Biotech of COVID-19 vaccine

The acquisition of Akorn India helped Biological E create a potential overall manufacturing capacity of over 1 billion doses per annum.

Providence will provide necessary technology transfer for Biological E to manufacture mRNA vaccines in India. Providence will provide necessary technology transfer for Biological E to manufacture mRNA vaccines in India.

The oldest Indian private vaccine maker, Hyderabad-based Biological E Limited, is emerging as a domestic powerhouse of COVID-19 vaccine manufacturing following its latest deal with Canada-based biotech company Providence Therapeutics.

In addition to the Providence deal, Biological E currently has a couple of in-house COVID-19 vaccines under development and another major manufacturing contract agreement for Johnson & Johnson's single-dose COVID-19 vaccine. It was among the earliest Indian companies to tap potential COVID-19 vaccine opportunities.

A pioneering biotech

Biological E currently makes eight World Health Organization (WHO) pre-qualified vaccines for tetanus, measles and rubella, pentavalent vaccines and snake anti-venom, and sells to over 100 countries. The company was started by Dr DVK Raju and G.A.N. Raju in 1953 as India's first biological products company manufacturing liver extracts and anti-coagulants.

It launched a biotechnology division (now Vaccines and Biologics Division) and commenced large-scale production of DPT vaccines as early as 1962. It also pioneered anti-blood clotting drug Heparin production in India. During 1960s and 1970s, Biological E developed formulations in cough and digestive enzymes, anti-tetanus serum, anti-TB drugs, TT and DTP vaccines, besides working as a contract manufacturer to GlaxoSmithKline. From 2008, it also started making pentavalent (DTP Hib HepB) vaccines.

In 1964, Evans Medicals, a UK-based pharma company which later merged with Glaxo SmithKline, acquired 40 per cent stake in the company.  This was subsequently bought back by the promoters in 1995.

Target COVID-19 vaccine

On August 13 last year, Biological E licensed a recombinant protein COVID-19 vaccine candidate, developed by Houston-based health sciences university Baylor College of Medicine. The university transferred the technology to Biological E for scaling up manufacturing and undertaking further development of the vaccine candidate.

"The deal is for development of an affordable vaccine, especially for India and other low- and middle-income nations," according to Mahima Datla, grand-daughter of company's founders and managing director of Biological E.

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"If the vaccine development is successful, we expect to make several hundred million doses of the vaccine available annually," Narender Dev Mantena, director of BioE Holdings Inc who heads Biological E's novel vaccine initiative, had said about the collaboration.

On the same day, Biological E announced another agreement with Janssen Pharmaceutica NV, one of Janssen Pharmaceutical companies of Johnson & Johnson, for creation and enhancement of manufacturing capacities for drug substance and drug product for Johnson & Johnson's COVID-19 vaccine candidate, Ad26.COV2.S. The candidate was then in phase 1/2a clinical trials stage.

Capacity addition

Within a week of those two deals, Biological E acquired Akorn India, a subsidiary of Akorn Inc., USA, primarily to access the facilities at Akorn India's Paonta Sahib Plant in Himachal Pradesh for commercial scale manufacturing of vaccines. The sterile injectable manufacturing facility has 39,000 square metres of built-up area spread over a 14-acre campus with an annual capacity for about 135 million units, with the potential for immediate expansion of a further 30 million units.

The acquisition helped Biological E create a potential overall manufacturing capacity of over 1 billion doses per annum if required, when its vaccines are ready for production. No other Indian vaccine makers has a capacity to make over a billion doses of vaccines, except the Serum Institute of India, which has a capacity of 1.6 billion doses a year and is further expanding it by nearly another 1 billion doses.

Own vaccine

By November, Biological E initiated phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DGCI). The vaccine candidate included an antigen in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, along with Dynavax's advanced adjuvant CpG 1018, to boost the immune response to produce more antibodies and longer lasting immunity.

The company's COVID-19 vaccine candidate is based on classical vaccine technology of a protein antigen, SARS-CoV-2 spike protein, adsorbed to the adjuvant Alhydrogel (Alum), in combination with another approved adjuvant, CpG 1018. It uses proven recombinant-protein technology and a safe agent to stimulate an immune response in cells. The trials were done in about 360 healthy subjects in the age group of 18-65 years with two doses, and a interval of 28 days between the doses. The results were to be made available by February 2021.

Soon CEPI (Coalition for Epidemic Preparedness Innovations), which works with the WHO's Covax Alliance to ensure equitable distribution of vaccines for low-income countries, collaborated for further development with a funding of $5 million for scaling up vaccine manufacturing, and assurance on additional funding to potentially enable production of 100 million doses in 2021. The candidate also received seed funding from Department of Biotechnology, Government of India.

In mid-April, 2021, the vaccine candidate got approval from the Central Drugs Standard Control Organization (CDSCO) - Subject Expert Committee (SEC) to start phase III clinical trials following successful completion of previous stage trials. Phase III clinical study is to be conducted at 15 sites across India in about 1,268 healthy subjects in the age group of 18 to 80 years, and plans are to conduct a larger global phase III study. The company plans to start the trials soon, and produce 75 million to 80 million doses per month from August, say sources.

More deals

With the latest deal with Providence, the Candaian company will provide necessary technology transfer for Biological E to manufacture mRNA vaccines in India, with a minimum production capacity of 600 million doses in 2022 and a target capacity of 1 billion doses. Biological E will be responsible for all clinical development and regulatory activities for the mRNA vaccine in India and other jurisdictions licensed by Biological E.

The vaccine candidate of Providence has concluded first phase human trials with favourable interim data. "We hope to provide India and other countries yet another option to ramp up their efforts towards achieving herd immunity against COVID-19," said Datla, who heads the company since 2001. At present there are two very successful mRNA vaccines in the global market from Pfizer-BioNTech and Moderna.

J&J was planning to make its single shot J&J vaccine in India under the Quad Vaccine Partnership, an alliance of India, US, Australia and Japan to make over a billion doses for use in Asia by the end of 2022. Biological E was looking to contract manufacture about 600 million doses of J&J vaccine annually, but so far has not revealed plans on starting manufacturing.

A month ago, J&J said it was in talks with India's government to begin clinical trial of its single-dose COVID-19 vaccine in the country, but as per the latest directive from the DCGI, such post bridging clinical trials are not required for globally approved COVID-19 vaccines. Once its vaccines get ready for production, Biological E is sure to emerge as a major COVID-19 vaccine maker from India.

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