HJB - Your Trusted Biologics CDMO Partner

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HJB - Your Trusted Biologics CDMO Partner

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Analytical Development for Drug Product

  • State-of-the-art Analytical Instruments and Software: Ensuring compliance with regulatory standards

  • Expert Impurity Characterization and Particle Identification: Establishing product purity and consistency

  • Lifecycle Management of QC Methods: Adhering to ICH, USP, and ChP guidelines for method development and validation

  • Comprehensive Analytical Support: Providing expertise throughout formulation development and testing during the drug product filling process

  • Specification Setting for Release and Stability: Establishing robust product specifications for release and long-term stability


    Through our analytical development services, we ensure that your drug products meet the highest quality and regulatory standards throughout their lifecycle.

Software

Waters Empower 3 CDS Spectrophotometer

BioPharma Finder MS Software

MyAssays Bioanalysis Software

Equipment

Waters Bioaccord LC-MS/ l-class UPLC

Sciex PA800 Plus CE

Agilent 1260 HPLC

Protein Simple iCE3 iclEF

Thermofisher Vanquish/ Q-Exactive UPLC-HRMS

Cytiva T200 Biacore SPR

Zip-Chip CE-MS Interface

MD i3X Plate Reader

Thermo 7500 Real Time PCR System

SERVICES