Serum Institute of India Pvt. Ltd.

Serum Institute of India Pvt. Ltd. is now the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses per year ) which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines etc. It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. 25 Vaccines manufactured by the Serum Institute are accredited by the World Health Organization, Geneva and are being used in around 170 countries across the globe in their national immunization programs, saving millions of lives throughout the world every year. Please refer the weblink ;
https://extranet.who.int/gavi/PQ_Web/Default.aspx?nav=2.

Serum Institute is ranked as India’s No. 1 biotechnology company. It manufactures highly specialized life saving biologicals using cutting edge genetic and cell based technologies, and also antisera and other medical specialties.

Serum Institute was founded in 1966 by Dr. Cyrus Poonawalla with the aim of making available life-saving immuno-biologicals, which were in shortage in the country that time and imported at high prices. It started manufacturing several life-saving biologicals in abundance and at prices affordable to the common man, with the result that India was made self-sufficient for Tetanus Anti-toxin and Anti-Snake Venom Serum, followed by DTP (Diphtheria, Tetanus and Pertussis) group of Vaccines and later on MMR (Measles, Mumps and Rubella) group of vaccines.

The Philanthropic philosophy of Dr.Poonawalla not just exists but has been proliferated to bring down the prices of newer vaccines such as Hepatitis-B vaccine, other Combination vaccines etc., so that not only Indian’s, but the under-privileged children of the entire world are protected from birth onwards.

Path-breaking acquisitions -
Bilthoven Biologicals, Netherlands

Serum Institute made its first International acquisition by acquiring Bilthoven Biologicals, a bioengineering and pharmaceutical company of The Netherlands Government on 29th June 2012. The takeover ensures access to technology and expertise for making the IPV (Injectable Polio Vaccine, Salk), earlier possessed by only 3 other vaccine manufacturers of the world. Bilthoven Biologicals is spread over 40 acres with an installed manufacturing capacity of over 20 million doses of vaccines annually. The production facilities are state-of-art and fully compliant with cGMP and biopharmaceutical requirements.

The acquisition enhances Serum Institute’s offerings in the paediatric vaccine segment and with this Serum Institute hopes to make a significant contribution to the eradication of Polio from the World. The takeover also provides an important manufacturing base in Europe, with access to strategic European Markets.

World Class Production Facilities

Producing over a billion doses of quality vaccines every year.

Serum Institute has established the most modern laboratories with high-tech machinery and computerized equipment for production and testing of its life saving biologicals. Serum Institute’s commitment to global health is exemplified by significant investments in its infrastructure. The production facilities are continuously upgraded to ensure compliance with cGMP regulations and have been accredited by the World Health Organization, Geneva.

Serum Institute has huge bio-reactors for manufacturing voluminous batch sizes of 2 to 4 million doses of its vaccines and also largest facility for lyophilization. The facilities are state-of-the-art, meet the internationally accepted environmental standards and also comply with BSL 2 and BSL 2+ standards. Equipment providing Class 100 and Class 10,000 conditions are electronically controlled avoiding manual handling.

Serum Institute has crossed many milestones in technological advancement by installing robotic arm for virus handling, cell factory and cell cube for growing cells, facilities for the manufacture of polysaccharide and recombinant vaccines and for monoclonal antibodies.
Sophisticated tunnel systems, and high speed vial washing-filling-stoppering-sealing machines are capable of working at a speed of 500 containers per minute and have been installed with filling accuracy to the third digit decimal point to ensure accuracy, consistency, and quality output.

Serum Institute has the latest technology screeners to inspect its products for any minute particulate matter undetectable to the normal eye. Configured with high resolution CCD cameras and electronically controlled panel, the inspection is done fully automatically, thus reducing the margins of human errors.

With the licensure of additional facilities, Serum Institute has the flexibility to produce vaccines in multiple plants, thus facilitating producing large quantities in shortest time frame. This enables the Institute to improve the response time to cater to any international emergency or outbreak.

Poonawalla Bio-Tech Park

The vision of global future needs of Dr.Poonawalla reflects in the upcoming Poonawalla Biotech Park spread over sprawling area of 42 acres. This state-of-the-art facility is designed to meet the highest standards set by a plethora of regulatory agencies including the MHRA, USFDA and those of Europe, Japan, Australia, etc. To begin with products like HPV, Tdap, Monoclonal Antibodies/Biosimilars, Rotavirus Vaccine, BCG Vaccine and recombinant BCG Vaccine etc. will be manufactured here using the latest technology. The Bio-Tech Park is expected to be functional by the beginning of 2019.

Commitment to Quality

Serum Institute’s quality control laboratories are very well equipped with a wide array of sophisticated analytical instruments such as HPLC with PDA detector, Fourier Transform Infra-Red Spectrophotometer, Gas Chromatograph, Atomic Absorption Spectrophotometer, real-time PCR, new Dionex, Karl Fischer Moisture Analyzer, ELISA Readers, Liquid Particle Counters, Capillary Zone Electrophoresis, Bio-Plex and several other state-of-the-art instruments. The technical team has developed systems to ensure that quality is inbuilt into the process, leading to consistency of output.

Regular training of our FDA approved competent technical staff in production and quality control testing upgrades the expertise through continuous professional development that is playing a significant role in this direction. Many of our experts are regularly sent for training to USA, UK, France, Netherlands, etc. This ensures that the latest advances in production and quality testing standards are quickly incorporated in our processes.

Periodic inspections of our facilities and product approvals obtained from the World Health Organization and from national as well as international regulatory authorities stand as testimony of Serum Institute’s commitment to quality.

Serum institute’s core scientists in R & D are working hard to further contribute in near future, towards global health by developing following vaccines :

• DTaP Vaccine
• TdaP Vaccine
• Measles Vaccine (Dry Powder)
• Aerosol Measles vaccine
• Rotavirus Vaccine (Liquid)
• Pentavalent Meningococcal Conjugate Vaccine (ACYWX)
• Human Papiloma Virus Vaccine (HPV)
• Recombinant BCG (rBCG) Vaccine
• Dengue Tetravalent Vaccine
• Hexavalent (DTP Hep B Hib IPV) Vaccine