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:
600kg
of monoclonal antibodies (mABs) per year
80
mammalian cell culture batches per year
150
microbial cell culture batches per year
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
140,000 sq. ft. multi product manufacturing facility
Designed for optimal man and material movement to mitigate cross contamination
Conceptualised with Quality-by-Design (QbD) principles
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
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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
12 November 24
EMA grants GMP certificate to CuraTeQ Biologics’ manufacturing facility in Hyderabad
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15 March 24
CuraTeQ Biologics successfully completes Phase 1 trial for Omalizumab biosimilar
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17 February 24
Auro Peptides completes US FDA inspection with zero observations
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17 January 24
CuraTeQ Biologics’ Trastuzumab Biosimilar receives recommendation for marketing authorization in India
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20 November 23
CuraTeQ Biologics eyes ‘WuXi’ moment to kickstart Indian bio-CDMO sector
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10 July 23
CuraTeQ Biologics to market Ustekinumab biosimilar to treat Crohn’s disease, arthritis
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05 July 23
CuraTeQ Biologics announces positive Phase-3 results for Trastuzumab biosimilar
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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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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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