Biosimilar Manufacturing 1

Fully integrated commercial scale facilities

Biosimilar Manufacturing Capabilities

Our biosimilars manufacturing centre in Hyderabad, India, is a fully integrated commercial scale facility. It has end-to-end capabilities in producing a full range of products from bulk drug substance (DS) to fill-finish and packaged drug products (DP).

Our dedicated mammalian and microbial production suites are built for 24:7 operation, with manufacturing capable of producing:

Biosimilar Manufacturing 2

600kg

of monoclonal antibodies (mABs) per year

Biosimilar Manufacturing 3

80

mammalian cell culture batches per year

Biosimilar Manufacturing 4

150

microbial cell culture batches per year

Biosimilar Manufacturing 5

The goal of our biosimilar manufacturing facility is to produce medicines of the highest quality and affordability.

CuraTeQ has strategically invested in its commercial scale biosimilar manufacturing facilities with world class equipment and infrastructure, which is globally compliant with various international regulatory norms.

It is a fully integrated modular facility with selectively automated production processes and systems to minimise human intervention. Our dedicated team of expert process engineers, production engineers, and operators are instrumental to the efficient and reliable operation of the facility.

Key features of our biosimilar manufacturing facilities

Biosimilar Manufacturing 6

140,000 sq. ft. multi product manufacturing facility

Biosimilar Manufacturing 7

Designed for optimal man and material movement to mitigate cross contamination

Biosimilar Manufacturing 8

Conceptualised with Quality-by-Design (QbD) principles

Biosimilar Manufacturing 9

Designed for Clean-In-Place (CIP) and Sterilisation-In-Place (SIP) operations

Segregated areas for mammalian and microbial bulk Drug Substance (DS) manufacturing

Automated buffer distribution and handling capabilities

Segregated fill finish lines for Vials and Pre-filled syringes/cartridges

Systems designed as per 21 CFR Part 11, and GAMP 5 ISPE guidelines

Centrally located warehouse for ease of servicing various manufacturing blocks

Continuous monitoring through Building Management Systems (BMS)

Biosimilar manufacturing facility deep dive

Select an area:

Packaging Facility

Packaging Facility

Microbial bio-bulk manufacturing facility

Mammalian bio-bulk manufacturing facility

Fill and Finish Facility

Warehouse

Engineering and Support Utilities

Our manufacturing facility is equipped with dedicated HVAC units with terminal HEPA filters in process areas, which provide clean filtered air to avoid cross contamination. Our manufacturing plant also houses various critical utilities in a dedicated “Utility Block” including:

  • Water for Injection (WFI) production facility & Pure steam generators
  • Gas distribution systems (Liquid Oxygen & Nitrogen)
  • Chillers (400 TR capacity) and Air dryers (122 CFM capacity)
  • Boilers to generate plant steam (6 Ton cumulative capacity)
  • UPS (120 KVA) and Power Backup/DG (1000 KVA, 1500 KVA)

Latest News

CuraTeQ Biologics successfully completes Phase 1 trial for Omalizumab biosimilar
Press Release

15 March 24

CuraTeQ Biologics successfully completes Phase 1 trial for Omalizumab biosimilar

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Auro Peptides completes US FDA inspection with zero observations
Press Release

17 February 24

Auro Peptides completes US FDA inspection with zero observations

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CuraTeQ Biologics’ Trastuzumab Biosimilar receives recommendation for marketing authorization in India
Press Release

17 January 24

CuraTeQ Biologics’ Trastuzumab Biosimilar receives recommendation for marketing authorization in India

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CuraTeQ Biologics eyes ‘WuXi’ moment to kickstart Indian bio-CDMO sector
Press Release

20 November 23

CuraTeQ Biologics eyes ‘WuXi’ moment to kickstart Indian bio-CDMO sector

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CuraTeQ Biologics to market Ustekinumab biosimilar to treat Crohn’s disease, arthritis
Press Release

10 July 23

CuraTeQ Biologics to market Ustekinumab biosimilar to treat Crohn’s disease, arthritis

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CuraTeQ Biologics announces positive Phase-3 results for Trastuzumab biosimilar
Press Release

05 July 23

CuraTeQ Biologics announces positive Phase-3 results for Trastuzumab biosimilar

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Aurobindo Pharma arm CuraTeQ expands scope of biosimilars distribution pact with Orion
Press Release

12 January 22

Aurobindo Pharma arm CuraTeQ expands scope of biosimilars distribution pact with Orion

Aurobindo Pharma on Tuesday said its subsidiary CuraTeQ Biologics has expanded the scope…

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Aurobindo Pharma forays into biosimilars development
Press Release

12 February 17

Aurobindo Pharma forays into biosimilars development

Aurobindo Pharma Limited is pleased to announce the acquisition of four cell culture derived biosimilar…

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