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BACTEC Validated for Sterility Testing of ATMP Suspensions

BACTEC can be used for sterility testing of ATMP Suspensions
ATMP - Advanced Therapeutic Medicinal ProductsCell and Gene TherapiesSterility Testing
02 Jan 2026 Lora Benoit Ph.D
The BACTEC automated microbial detection system reliably detects low-level contamination (≥ 5 CFU) in stem cell products suspended in Ringer’s Lactate, demonstrating full concordance with pharmacopeial sterility testing while delivering significantly faster results.
Assay Development

Shedding Light on 'Low Endotoxin Recovery' in LAL Assays

Low Endotoxin Recovery in LAL Assays
Clinical TrialsEndotoxinPyrogen Free Labware
04 Dec 2025 Lora Benoit Ph.D
Excipients used in pharmaceutical formulations can induce endotoxin masking, causing the Limulus Amebocyte Lysate (LAL) assay to underestimate true endotoxin levels. Gorman et al. show that masking arises from excipient-driven alterations in endotoxin structure and aggregate size.
Clinical & Veterinary Assay Development

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