Committed to a culture of quality excellence
Quality Control Laboratories
Driven by a quality first culture, the Quality Control teams at CuraTeQ are engaged across the entire spectrum of physiochemical, bioassay, and microbiological analyses involved in the rigorous verification and testing of biosimilar development.
Equipped with best-in-class equipment and procedures that are compliant with ICH Q9, USP, and EP quality guidelines, our Quality Control labs play an instrumental role in executing drug substance and drug product release testing, analytical method transfer, compendial method verification, and analytical method validation activities.
Our Quality Control team forms a crucial nexus for collaborative engagement with biosimilar developmental, manufacturing, manufacturing science and technology (MSAT), and quality assurance teams.
The state-of-the-art facility is designed with segregated areas that enable seamless and precise end-to-end operations across all testing stages from raw materials to final drug product.
Key features of our quality control laboratories
Segregated area for sample receipt and management for analysis
Integrated with STARLIMS® automation systems to monitor and handle all QC analyses
Fully GMP compliant, with analytical equipment in compliance with 21 CFR part 11 guidelines
Equipped to support environmental and clean utility monitoring programs
Dedicated areas for culture handling, microbial testing, and sterility testing
Dedicated storage areas for stability samples, reference standards, control, and retention samples
Analytical laboratory
Raw material & packaging material testing laboratory
Bioassay laboratory
Microbiology laboratory
Latest News
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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