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Biocon Biologics’ New Monoclonal Antibodies Manufacturing Facility Wins ISPE’s 2021 Facility of the Year Honorable Mention Award

  • Posted by: BIOCON

Bengaluru, India; April 28, 2021: 

Biocon Biologics Ltd., a fully integrated ‘pure play’ biosimilars company and a subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), announced today that it has been awarded with the 2021 Facility of the Year Award (FOYA) from the International Society for Pharmaceutical Engineering (ISPE). The company received an Honorable Mention award for its monoclonal antibodies drugs substances manufacturing facility located at Biocon Park, Bengaluru, a ~100-acre integrated complex with all infrastructure and utilities.

This is the first time that a biopharmaceutical company from India has been awarded an ISPE FOYA Honorable Mention. Every year, ISPE’s FOYA program recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines and demonstrate advances in project delivery.

Biocon Biologics’ new 340,000-square feet B3 facility is being built in a modular manner to allow for expansion into Phase 2. This is one of the largest monoclonal antibodies (mAbs) manufacturing facilities in India in terms of built area for a single building/site.  The first phase of the facility has been built at an investment of ~USD 120 million.

The facility will enhance the Company’s manufacturing capacity for mAbs manifold and improve its ability to enable affordable access for patients across the globe. The facility is intended for commercial and clinical manufacturing for global regulated markets, including the U.S. and Europe. The Phase I of the facility has completed qualification and is preparing for commercialization.

Shreehas Tambe, Deputy Chief Executive Officer, Biocon Biologics said: “The ISPE Facility of the Year Award is a proud moment for us at the Biocon Group. This prestigious award is a recognition of Biocon Biologics’ design, project management, execution capabilities and above all the determination of the entire team to succeed despite the several challenges of 2020. I would like to acknowledge the remarkable collaboration between the project team, various functions, our consultants, partners, vendors for their tireless efforts which allowed us to successfully complete and commission this award-winning biologics manufacturing facility.”

“Biocon Biologics’ project team clearly articulated their understanding of an environmental impact associated with such a large facility and demonstrated their focused efforts to minimize the impact through multiple sustainability elements built within the facility design. In addition to the environmental impact, this project team demonstrated a superior execution approach in managing construction safety,” said the FOYA Judging Committee.

The project was completed on schedule and within budget in a period of 24 months from start of construction. This fast track project was achieved with around 3 million safe man hours.

The B3 facility has been built in a sustainable manner to ensure maximum energy conservation and the design of equipment and facility is well optimized to reduce operational expenses.

Biocon Biologics is making continued investments in building global scale, cost-competitive, complex manufacturing capabilities to address market opportunities worldwide and enhance patient access to its high quality biosimilars.

The other FOYA category winners this year were:

  • Takeda Pharmaceuticals International AG (Facility Integration)
  • ElevateBio (Operational Excellence)
  • Takeda Pharmaceuticals International AG (Process Intelligence and Innovation)
  • Janssen Sciences Ireland (Project Execution)
  • Government Pharmaceutical Organization (Social Impact)
  • Gilead Sciences, Inc. (Special Recognition Awards for Operational Agility: COVID-19 Impact)
  • Grand River Aseptic Manufacturing (Special Recognition Awards for Operational Agility: COVID-19 Impact)
  • Locus Biosciences (Honorable Mention)
  • Raymond G. Perelman Center for Cellular and Molecular Therapeutics (Honorable Mention)

About the ISPE Facility of the Year Awards Program
Established in 2004, The Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches. Visit ISPE.org/FOYA for more information.

About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000 Members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. Visit ISPE.org for more information.

About Biocon Biologics Limited:
Biocon Biologics Limited, a subsidiary of Biocon Limited is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world. Building on the four pillars of Patients, People, Partners and Business, Biocon Biologics is committed to transforming healthcare and transforming lives. Biocon Biologics is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases. Five molecules from Biocon Biologics’ portfolio have been taken from lab to market, of which three have been commercialized in developed markets like United States, EU, Australia, Canada and Japan. With a team of over 4,800 people Biocon Biologics aspires to transform healthcare through affordable innovative solutions as well as impact millions of patients’ lives. Biocon Biologics on the Web ; Follow-us on Twitter:  @BioconBiologics

About Biocon Limited:
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as generic formulations in the US and Europe. It also has a pipeline of promising novel assets in immunotherapy under development.  Website: www.biocon.com; Follow-us on Twitter: @bioconlimited

Author: BIOCON
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