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Biocon  /  Businesses  /  Biosimilars  /  Global Scale Manufacturing

BIOCON BIOSIMILARS

Global Scale Manufacturing

We are rapidly growing our development, regulatory and clinical expertise, along with world class manufacturing capabilities, to break existing oligopolies and make therapies affordable to patients globally. Biocon Biologics’ state-of-the-art manufacturing facilities are certified by various regulatory agencies from developed and emerging markets.

With an unwavering commitment to quality, the Biocon Biologics has made significant investments in commercial scale, globally compliant manufacturing facilities across diverse technology platforms spanning insulin analogs, monoclonal antibodies and other recombinant proteins. We continue to expand our infrastructure in a capital-efficient, modular way.

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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

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, and markets them in Malaysia, EU and several other key emerging markets.
In Malaysia, our focus has been to create a Center of Excellence (CoE) for insulins. The CoE achieved two key milestones with the commercialization of bGlargine in the U.S. and the approval of bAspart in EU in FY21. Enabling this CoE is a strong team spanning personnel from the R&D, Manufacturing, Quality, Regulatory and Commercial functions. With the EU approval for bAspart, we are now manufacturing a broad portfolio of regular, basal and rapid insulins end to end at our state-of-the-art insulins facility in Malaysia.

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 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 Formulation & 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 Biocon’s 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

CORPORATE GOVERNANCE
KEY THERAPEUTIC AREAS
RESEARCH SERVICES
OUR CULTURE
RESPONSIBILITY
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