BioTechnique® Launches Expanded QC Services: Advanced Analytical, Lyophilization Product Development, Microbiology, and Environmental Monitoring with Real‑Time eQMS Reporting
February 9, 2026 | Press Release
York, PA — BioTechnique®, a full‑service CRDMO, announced an expanded Quality Control (QC) services portfolio, combining advanced analytical testing, lyophilization product development, comprehensive microbiology, environmental monitoring, and cloud‑native eQMS reporting to accelerate release decisions and strengthen audit readiness for pharmaceutical and biotech sponsors.
Expanded Quality Control Capabilities
Analytical testing: High Performance Liquid Chromatography (HPLC) / Ultra Performance Liquid Chromatography (UPLC), Fourier Transform Infrared Spectroscopy (FTIR), Gas Chromatography (GC), Ultraviolet Visible spectroscopy (UV-Vis), Karl Fischer (coulometric & volumetric), Total Organic Carbon (TOC), pH & conductivity, osmolality, and Differential Scanning Calorimetry (DSC)—supporting method execution from identity/assay to stability‑informing characterization.
Microbiology: Endotoxin, bioburden, sterility testing in SKAN isolators, and MALDI‑TOF microbial identification for rapid, species‑level analyses.
Lyophilized Product Development: Lab‑scale lyo, Freeze Drying Microscopy (Lyostat 5 FDM), Micropress, and DSC to inform robust cycle development and product elegance.
Environmental Monitoring (EM): Viable air (active/passive), non‑viable particle counting, and surface/personnel programs aligned to ISO/USP/EU Annex 1 expectations.
Electronic QMS (ACE®): Cloud‑native eQMS with controlled documentation, real‑time tracking, and data‑driven reporting for inspections and lifecycle control.
BioTechnique’s QC services sit inside a broader in‑house CRDMO platform—formulation, fill‑finish, lyophilization, warehousing, and shipping—reducing handoffs and shortening the path from testing to product movement (including 3PL), while maintaining a single chain of documentation.
About BioTechnique
BioTechnique, a division of PSC Biotech Corporation, is a full-service Contract Research, Development, and Manufacturing Organization (CRDMO) specializing in cytotoxic and therapeutic sterile injectable fill-finish services. BioTechnique provides comprehensive support from investigation and clinical stages through commercialization, batch sizes both large and small.
BioTechnique operates a state-of-the-art facility designed to handle a diverse range of pharmaceutical products, including cytotoxic and highly potent compounds, therapeutics, antibody-drug conjugates (ADCs), monoclonal antibodies, suspensions, and vaccines. Supported by an environmentally controlled warehouse and adaptable manufacturing systems, BioTechnique is committed to delivering high-quality fill-finish solutions.
For more information on BioTechnique’s capabilities, visit www.biotechnique.com.
Media Contact:
BioTechnique Business Development Group
(717) 377-3547