From Business today article on Biological E company and its 3 vaccines
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.
Only other vaccine maker other than serum institute of India to have a Billion vaccines per year
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.
It has 3 vaccines in its portfolio-- only company in the world with its own 2 vaccines along with another licensed
1) Corbevax 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.
GOI has contracted for about 30 crores of this vaccine, released about 1500 crores(30% of total) for now . remaining will be paid later.
This vaccine expected to be the cheapest .
2) MRNA vaccine-- 3rd vaccine after pfizer and moderna
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.
3) Johnson vaccine single dose for quad allaince which is being talked about-- Biological E expected to manufcature in excess of 600 million if all goes well.