BioTechnique expands QC services with advanced analytics, lyophilization development, microbiology, monitoring, and cloud eQMS to speed product release.
YORK, PA, UNITED STATES, February 19, 2026 /EINPresswire.com/ — 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 clients.
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 lyophilization, Freeze Drying Microscopy (Lyostat 5 FDM), Micro press, 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.
Daniel Silva
BioTechnique
+1 215-796-2369
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