Serum Institute of India
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Serum Institute of India (SII) is an Indian
biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...
and
biopharmaceuticals A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...
company, based in
Pune Pune (; ; also known as Poona, (List of renamed Indian cities and states#Maharashtra, the official name from 1818 until 1978) is one of the most important industrial and educational hubs of India, with an estimated population of 7.4 million ...
. It is the world's largest manufacturer of
vaccines A vaccine is a biological preparation that provides active acquired immunity The adaptive immune system, also known as the acquired immune system, is a subsystem of the immune system that is composed of specialized, systemic cells and pro ...
. It was founded by
Cyrus Poonawalla Cyrus S. Poonawalla (born in 1941) is an Indian billionaire businessman, and the chairman and managing director of the Cyrus Poonawalla Group, which includes the Serum Institute of India, an Indian biotech company which is the largest vaccine m ...
in 1966 and is a part of Cyrus Poonawalla Group.


Overview

The Serum Institute of India was founded in 1966 in the city of
Pune Pune (; ; also known as Poona, (List of renamed Indian cities and states#Maharashtra, the official name from 1818 until 1978) is one of the most important industrial and educational hubs of India, with an estimated population of 7.4 million ...
, India. The company set out to produce immunobiologicals, which were imported into India at high prices. Among the first products the Serum Institute of India manufactured in large quantities were the
tetanus antitoxin Anti-tetanus immunoglobulin, also known as tetanus immune globulin (TIG) and tetanus antitoxin, is a medication made up of antibodies against the tetanus toxin. It is used to prevent tetanus in those who have a wound that is at high risk, have ...
, snake
antivenom Antivenom, also known as antivenin, venom antiserum, and antivenom immunoglobulin, is a specific treatment for envenomation. It is composed of antibodies and used to treat certain venomous bites and stings. Antivenoms are recommended only if th ...
,
DPT vaccine The DPT vaccine or DTP vaccine is a class of combination vaccines against three infectious diseases in humans: diphtheria, pertussis (whooping cough), and tetanus. The vaccine components include diphtheria and tetanus toxoids and either kille ...
, and
MMR vaccine The MMR vaccine is a vaccine against measles, mumps, and rubella (German measles), abbreviated as ''MMR''. The first dose is generally given to children around 9 months to 15 months of age, with a second dose at 15 months to 6 years of age, ...
. The company's product lines was expanded to include different types of
vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...
s against
bacterial Bacteria (; singular: bacterium) are ubiquitous, mostly free-living organisms often consisting of one biological cell. They constitute a large domain of prokaryotic microorganisms. Typically a few micrometres in length, bacteria were among ...
or
virus A virus is a submicroscopic infectious agent that replicates only inside the living cells of an organism. Viruses infect all life forms, from animals and plants to microorganisms, including bacteria and archaea. Since Dmitri Ivanovsky's 1 ...
infections, combination vaccines,
influenza vaccine Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies fr ...
, and
meningococcal vaccine Meningococcal vaccine refers to any vaccine used to prevent infection by '' Neisseria meningitidis''. Different versions are effective against some or all of the following types of meningococcus: A, B, C, W-135, and Y. The vaccines are between 8 ...
. Besides vaccine the company also manufactures
antisera Antiserum is a blood serum containing monoclonal or polyclonal antibodies that is used to spread passive immunity to many diseases via blood donation (plasmapheresis). For example, convalescent serum, passive antibody transfusion from a previ ...
,
blood plasma Blood plasma is a light amber-colored liquid component of blood in which blood cells are absent, but contains proteins and other constituents of whole blood in suspension. It makes up about 55% of the body's total blood volume. It is the intra ...
, and
hormone A hormone (from the Greek participle , "setting in motion") is a class of signaling molecules in multicellular organisms that are sent to distant organs by complex biological processes to regulate physiology and behavior. Hormones are required ...
products. As of 2014 the vaccines manufactured by the Serum Institute of India have been used in international vaccination programmes run by the
World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
(WHO),
UNICEF UNICEF (), originally called the United Nations International Children's Emergency Fund in full, now officially United Nations Children's Fund, is an agency of the United Nations responsible for providing Humanitarianism, humanitarian and Devel ...
, and the
Pan American Health Organization The Pan American Health Organization (PAHO) is an international public health agency working to improve the health and living standards of the people of the Americas. It is part of the United Nations system, serving as the Regional Office for ...
(PAHO). Today the Serum Institute of India is run by the Poonawalla Group and engages in research, development, and manufacturing. In 2009 the company began developing an intranasal
swine flu Swine influenza is an infection caused by any of several types of swine influenza viruses. Swine influenza virus (SIV) or swine-origin influenza virus (S-OIV) refers to any strain of the influenza family of viruses that is endemic in pigs. As o ...
vaccine. In 2012, the company's first international acquisition was Bilthoven Biologicals, a biopharmaceutical company in Netherlands. In 2016, with support from US-based Mass Biologics of
University of Massachusetts Medical School The University of Massachusetts Chan Medical School is a public medical school in Worcester, Massachusetts. It is part of the University of Massachusetts system. It is home to three schools: the T.H. Chan School of Medicine, the Morningside Grad ...
, the Serum Institute of India invented a fast-acting anti-
rabies Rabies is a viral disease that causes encephalitis in humans and other mammals. Early symptoms can include fever and tingling at the site of exposure. These symptoms are followed by one or more of the following symptoms: nausea, vomiting, vi ...
agent, Rabies Human Monoclonal Antibody (RMAb), also known as Rabishield. , the company is the world's largest vaccine producer by number of doses produced, manufacturing around 1.5 billion doses of vaccines each year. The products developed include tuberculosis vaccine Tubervac ( BCG), Poliovac for
polio Poliomyelitis, commonly shortened to polio, is an infectious disease caused by the poliovirus. Approximately 70% of cases are asymptomatic; mild symptoms which can occur include sore throat and fever; in a proportion of cases more severe s ...
myelitis, and other vaccinations for the childhood vaccination schedule.


COVID-19 vaccine development

The company has partnered with the British-Swedish multinational pharmaceutical company
AstraZeneca AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas includin ...
, which is developing AZD1222 (Covishield) in partnership with the
University of Oxford , mottoeng = The Lord is my light , established = , endowment = £6.1 billion (including colleges) (2019) , budget = £2.145 billion (2019–20) , chancellor ...
. It is reported that Serum Institute of India would provide 100 million (10
crore A crore (; abbreviated cr) denotes ten million (10,000,000 or 107 in scientific notation) and is equal to 100 lakh in the Indian numbering system. It is written as 1,00,00,000 with the local 2,2,3 style of digit group separators (one lakh is e ...
) doses of the vaccine for India and other low and middle-income countries. This target was later increased to 1 billion doses by the end of 2021. It is estimated to be priced at ₹225 (around $3) per dose. In September 2020, trials were halted by
DCGI Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood pro ...
after a volunteer in Oxford developed illness following vaccination, but were soon resumed after consent by the British regulators. In December 2020, the Serum Institute of India sought emergency approval for the vaccine developed with AstraZeneca which was approved a month later. In March 2021, an agreement was reached to supply some doses to the UK. Serum Institute of India has also reached an agreement with
Novavax Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for influenza and respiratory s ...
for the production of Novavax's
NVX-CoV2373 The Novavax COVID-19 vaccine, sold under the brand names Nuvaxovid and Covovax, among others, is a subunit COVID-19 vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). Full results from Nuvaxovid's p ...
(Covovax) vaccine for India and other low and middle-income countries. The company will also produce Codagenix's nasally administered
COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was COVID-19 pandemic in Hubei, identified in Wuhan, China, in December ...
vaccine CDX-005 (tradename '' COVI-VAC''). The company is also manufacturing
Sputnik V Sputnik V (russian: Спутник V, the brand name from RDIF) or Gam-COVID-Vac (russian: Гам-КОВИД-Вак, the name under which it is legally registered and produced) is an adenovirus viral vector vaccine for COVID-19 developed by ...
vaccine in India in collaboration with
Gamaleya Research Institute of Epidemiology and Microbiology The Gamaleya Research Institute of Epidemiology and Microbiology,russian: Национальный исследовательский центр эпидемиологии и микробиологии имени почётного академ ...
after receiving approval from DCGI. On 13 July 2021, RDIF published a press release saying SII is starting the production of
Sputnik V Sputnik V (russian: Спутник V, the brand name from RDIF) or Gam-COVID-Vac (russian: Гам-КОВИД-Вак, the name under which it is legally registered and produced) is an adenovirus viral vector vaccine for COVID-19 developed by ...
doses in September 2021. They intend to produce over 300 million doses of the vaccine in India per year.


Attempted data theft

In March 2021,
Reuters Reuters ( ) is a news agency owned by Thomson Reuters Corporation. It employs around 2,500 journalists and 600 photojournalists in about 200 locations worldwide. Reuters is one of the largest news agencies in the world. The agency was estab ...
reported that Chinese state-backed cyber-espionage group
Red Apollo Red Apollo (also known as APT 10 (by Mandiant), MenuPass (by Fireeye), Stone Panda (by Crowdstrike), and POTASSIUM (by Microsoft)) is a Chinese state-sponsored cyberespionage group. A 2018 indictment by the United States Department of Justice c ...
targeted the Serum Institute of India's intellectual property for exfiltration.


See also

*
Bharat Biotech Bharat Biotech International Limited (BBIL) is an Indian multinational biotechnology company headquartered in the city of Hyderabad, India engaged in the drug discovery, drug development, manufacture of vaccines, bio-therapeutics, pharmaceuti ...
*
Cadila Healthcare Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad, which is primarily engaged in the manufacture of generic drugs. It ranked 100th in the Fortu ...
*
Biotechnology in India Biotechnology in India is a sunrise sector within the Indian economy. Agencies of the Government of India concerned with the biotechnology industry include the Department of Biotechnology and the proposed Biotechnology Regulatory Authority of Indi ...


References


External links


Official website
{{Authority control Biotechnology companies of India Vaccine producers Manufacturing companies based in Pune Indian companies established in 1966 Biotechnology companies established in 1966 1966 establishments in Maharashtra Biopharmaceutical companies Immunology organizations Pharmaceutical companies of India COVID-19 vaccine producers