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

Biosimilar Research 1

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

CuraTeQ Biologics successfully completes Phase I study for Denosumab biosimilar
Press Release

10 April 25

CuraTeQ Biologics successfully completes Phase I study for Denosumab biosimilar

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CuraTeQ Biologics receives CHMP positive opinion for Pegfilgrastim biosimilar
Press Release

31 January 25

CuraTeQ Biologics receives CHMP positive opinion for Pegfilgrastim biosimilar

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CuraTeQ Biologics receives UK MHRA approval for Bevqolva™ (Bevacizumab biosimilar)
Press Release

21 December 24

CuraTeQ Biologics receives UK MHRA approval for Bevqolva™ (Bevacizumab biosimilar)

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CuraTeQ Biologics receives CHMP positive opinion for Filgrastim biosimilar
Press Release

13 December 24

CuraTeQ Biologics receives CHMP positive opinion for Filgrastim biosimilar

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EMA grants GMP certificate to CuraTeQ Biologics’ manufacturing facility in Hyderabad
Press Release

12 November 24

EMA grants GMP certificate to CuraTeQ Biologics’ manufacturing facility in Hyderabad

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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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Overview
CuraTeQ Biologics

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