Minaris Advanced Testing provides GMP lot release testing services for biologic therapeutics to ensure every batch of your biologic product meets regulatory requirements for identity, purity, potency and safety. We offer comprehensive, phase-appropriate testing backed by qualified and validated methods and harmonized global procedures.
Lot release testing is available as both a standalone offering for external clients and an integrated service for CDMO programs.
Minaris delivers lot release testing packages designed for:
Typical release panels include:
Sterility
USP <71> / Ph. Eur. 2.6.1
Mycoplasma
PCR and culture methods
Endotoxin
LAL (kinetic chromogenic, rapid Endosafe®)
Identity
STR profiling, sequencing
Potency
Cell-based potency assays with various endpoints (PCR, ELISA, flow cytometry, etc.)
Purity and Impurities
UPLC, HPLC, CE, SDS-PAGE, ELISA
Residuals
Host cell proteins/DNA, reagents
Vector Copy Number / Titer
qPCR, ddPCR
Viability and Cell Count
Manual and automated methods
Adventitious agent testing
Titration
RCL/rcAAV testing
Compendial methods
For sponsors who require new or sponsor-developed methods, Minaris supports:
We ensure alignment with global regulatory authorities, including the FDA, EMA and PMDA.
Whether you need GMP release testing for a commercial therapy or exploratory analysis for an early-phase asset, we’re here to help. Access our full testing catalogue or submit a sample request today.
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Minaris Advanced Therapies is dedicated to helping innovators in cell and gene therapy succeed. Whether you are in early-stage development or preparing for commercial launch, our end-to-end expertise, global reach and commitment to quality make us the ideal partner for cell and gene therapy manufacturing and GMP biosafety and analytical testing of all biologics.
