Serum Institute of India Everything You Need to Know About the World’s Largest Vaccine Maker

From Ahlam Rais*

The Serum Institute of India (SII) has been producing more than 20 different types of vaccines and supplying it to numerous countries across the globe since ages but it was the biopharma company’s Covid-19 vaccine that made headlines amidst the Coronavirus pandemic. With state-of-the-art technologies and equipment, the production facilities at the firm’s Pune site in India meet the highest standards of various regulatory agencies. PROCESS Worldwide offers an insight into the world’s biggest vaccine factory.

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The facilities safety and technical standards can be compared to other giants from the industry such as the American pharma firms Pfizer and Moderna as they use the same equipment, sourced from Germany, Europe, and the USA.
The facilities safety and technical standards can be compared to other giants from the industry such as the American pharma firms Pfizer and Moderna as they use the same equipment, sourced from Germany, Europe, and the USA.
(Source: Serum Institute of India)

With more than 1.5 billion doses produced and sold globally, the Serum Institute of India is the world's largest vaccine manufacturer. Founded by Dr. Cyrus Poonawalla in 1966, the biopharmaceuticals company began its journey by producing affordable immuno-biologicals as well as numerous life-saving biologicals for the Indian market at a time when the country had to shell out large amounts of money to import vital vaccines.

Today, more than 20 different types of vaccines such as Covid-19, polio, diphtheria, tetanus, pertussis, Hib, BCG, r-hepatitis B, measles, mumps and rubella are being produced by SII and supplied to around 170 countries across the globe, thus supporting their national immunization programs. With the growing need for affordable vaccines especially in low and middle-income nations, the Pune-based firm strives to bring down the prices of newer vaccines such as the Covid vaccine, Hepatitis-B vaccine, Combination vaccine etc.

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Serum Institute of India’s Covid-19 vaccine

SII shot to fame with its Covid-19 vaccine Covishield amidst a global pandemic. Developed together with the Oxford University and the British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca, the vaccine is produced in India and secured the World Health Organization’s (WHO) approval for emergency use in February 2021. However, the overall process of getting these vaccines to the market was not easy.

In an interview to media channels, Adar Poonawalla, CEO of the Serum Institute of India said that the challenge was to produce vaccines at a speed never done before. They had to stop the production of other vaccines and use those plants to do high scale R&D which they would have done on a small scale under normal circumstances. We tried getting in touch with SII for further inputs, however, they were not available for comments.

Heinrich Meintrup, Senior Vice President – Head of BU Pharma & Healthcare, GEA in an online session at one of the trade fairs focused on the process industries had stated, “The Covid pandemic is a very unusual situation and has its own challenges. The speed that we need in this scenario, can only be achieved by using existing facilities as well as equipment that already exist. Only with this, can we upscale production within months which normally in our pharmaceutical world takes years.” This seemed true for SII as it managed to rapidly manufacture the vaccine in record time due to its vast experience in producing multiple vaccines and supplying it to developing and under developed markets. Now, the firm continues to develop Covid-19 vaccines under the global vaccine-sharing program Covax for lower-income countries.

SII’s mega production complex in Pune, India comprises many units where vaccines are produced, checked for quality, and transferred into sterilized vials.
SII’s mega production complex in Pune, India comprises many units where vaccines are produced, checked for quality, and transferred into sterilized vials.
(Source: Serum Institute of India)

@SII’s mega production facility

Spread across 42 acres, SII’s mega production complex in Pune, India comprises many units where vaccines are produced, checked for quality, transferred into sterilized vials, stored and then prepared for delivery.

Equipped with cutting edge technology and computerized equipment such as automated lines from reputed German brands such as Bosch and Groninger which provide high speed vial washing, filling, stoppering and sealing via sophisticated tunnel systems. Working at a speed of 500 containers per minute, the machines offer filling accuracy to the third digit of decimal point to ensure consistency.

The Covid-19 vaccines are stored and then prepared for delivery.
The Covid-19 vaccines are stored and then prepared for delivery.
(Source: Serum Institute of India)

Robotic arms are also installed for virus handling, cell factory and cell cube for growing cells along with high resolution CCD cameras and electronic controlled panel for automatic inspection at the manufacturing plant. All these technologies combined have helped the company to remove human intervention and deliver high-quality vaccines.

High safety and technical standards

The CEO has also mentioned in its many interviews to the media that its facilities safety and technical standards can be compared to other giants from the industry such as the American pharma firms Pfizer and Moderna as they use the same equipment, sourced from Germany, Europe, and the USA.

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For instance, regarding quality control, the company’s laboratories make use of numerous high-end analytical equipment such as HPLC with PDA detector, fourier transform infra-red spectrophotometer, gas chromatograph, atomic absorption spectrophotometer, real-time PCR, new Dionex, moisture analyzer from Karl Fischer, Elisa readers, liquid particle counters, capillary zone electrophoresis, Bio-Plex and many other solutions to ensure high quality of its products.

The company’s laboratories make use of numerous high-end analytical equipment to ensure high quality of its products.
The company’s laboratories make use of numerous high-end analytical equipment to ensure high quality of its products.
(Source: Serum Institute of India)

The production facilities at the Pune site are continuously upgraded to ensure compliance with cGMP regulations and are designed to meet the highest standards set by diverse regulatory agencies around the world such as the MHRA, US-FDA, etc. He goes on to say that the only advantage that the company has as compared to its western counterparts is the cost factor of manpower and energy.

The company’s laboratories make use of numerous high-end analytical equipment to ensure high quality of its products.
The company’s laboratories make use of numerous high-end analytical equipment to ensure high quality of its products.
(Source: Serum Institute of India)

Coming soon: the world’s largest pandemic facility in one location

For the near future, SII is building the world’s largest pandemic facility in one location – Pune, India which is expected to churn out a billion doses or more every year. On completion, export to about 150 countries will be possible with this new plant. Work on the project has already begun and is scheduled to be commissioned in the next few years.

* The author is a freelance editor at PROCESS Worldwide. Contact: ahlam.rais@vogel.com

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