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Biocon Biologics  /  Our Capabilities  /  Global Scale Manufacturing

GLOBAL SCALE MANUFACTURING

Biocon has made significant investments on building a commercial scale, globally-compliant manufacturing infrastructure across diverse technology platforms. Biocon Biologics’ state-of-the-art manufacturing facilities – both microbial and mammalian – are designed to conform to the most stringent cGMP guidelines, comply with international regulatory standards and meet client requirements worldwide. Our products are manufactured at scale for both developed and emerging markets in Bengaluru (India) and Johor (Malaysia).

Our investments in building on a global scale have led us to rank among the world’s Top 15 biomanufacturing companies. We are among the leading insulin producers worldwide and have one of the largest antibodies manufacturing capacities in South Asia.

The breadth and scale of Biocon Biologicsmanufacturing technologies encompass large-scale microbial fermentation, mammalian cell culture, protein & antibody purification, aseptic formulation and fill-finish. Our manufacturing facilities are designed for stringent cGMP standards and are supported by state-of-the-art process development and quality control laboratories and an efficient service infrastructure.

Our capabilities and technologies have helped us emerge as an end-to-end player with a strong pipeline of approved biosimilars.

Our investment strategy is to build capacity in a modular manner, in line with our projection of market opportunity.

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Award-Winning mAbs Facility in Bengaluru

Our 350,000 sq. ft. mAbs Drug Substance (B3) facility in Biocon Park is one of the largest mAbs manufacturing facilities in India in terms of the built-up area of a single building/site. This is India’s first biopharma facility awarded by the International Society for Pharmaceutical Engineering (ISPE).

Malaysia: Center of Excellence (CoE) for Insulins

Biocon Biologics has created a Center of Excellence (CoE) for insulins in Malaysia with end-to-end capabilities to manufacture a broad portfolio of regular, basal and rapid insulins. The state-of-the-art insulins facility in Johor is the first and only biopharmaceutical sterile injectables facility in Malaysia to receive the U.S. Food and Drug Administration (FDA) and European Medicines Agency approvals. More recently, Biocon’s biosimilar insulin Glargine made at Malaysia received a historic U.S. FDA approval as the ‘first interchangeable biosimilar’.

The 562,000 sq. ft. facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by the prestigious Malaysia Book of Records, which officially recognizes record-creating and record-breaking achievements in the fields of human endeavour, building & structures, transportation, arts & entertainment, business, sports & games, science & technology, nature etc. in Malaysia.

Our facility in Malaysia is Asia’s largest integrated insulins facility that manufactures Drug Substance and Drug Products in vials, cartridges and insulin delivery devices.

TECHNOLOGY PLATFORMS

Proprietary Pichia Pastoris Platform

Biocon’s pichia pastoris platform for expression of recombinant protein is our proprietary technology which is applied in the recombinant human insulin and insulin analog product lines. We were pioneers in commercialising the large-scale manufacture of human insulin using this technology.

Mammalian Cell Structure

Biocon Biologics has established a large-scale, multi-product, cell culture facility as the core technology in manufacturing key biologics like monoclonal antibodies (mAbs). Our consistent and scalable mammalian CHO and NSO cell-based expression platforms help us deliver novel and biosimilar mAbs.

Formulations And Fill-finish

Biocon’s expertise in Formulations & Product Science enables us to convert drug substances into formulations for transfer into vials, cartridges and pre-filled syringes at our devices’ facilities. The launch of rh-insulin in 2004 marked our foray into the aseptic formulations space.

GLOBAL GMP CERTIFICATIONS
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U.S. FDA
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EMA
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Central Drugs Standard Control Organisation, India
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PMDA, Japan
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COFEPRIS, Mexico
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ANVISA, Brazil
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MCC, South Africa
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Ministry of Health, Turkey
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Ministry of Health, Iran
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Ministry of Health, Russia
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NPRA, Ministry of Health, Malaysia
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Ministry of Food and Drug Safety (MFDS), South Korea
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TGA, Australia
FACILITIES
BANGALORE
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Drug substances

Insulins, Monoclonal
Antibodies & Other
Recombinant Proteins

Drug products

Sterile Injectables
– Vials
– Lypholized Vials
– Cartridges
– Pre-filled Syringes

Drug products

Devices
– Reusable Pens
– Disposable Pens

MALAYSIA
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Drug substances

rh-Insulin and
insulin analogs

Drug products

Sterile Injectables
– Vials
– Lypholized Vials
– Cartridges
– Pre-filled Syringes

Drug products

Devices
– Disposable Pens

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