Endotoxin, sterility, mycoplasma, and identity testing run inside our own microbiology lab — rapid and compendial methods side by side, integrated into our full CDMO services across development, manufacturing, and testing so release data moves with your program.
A dedicated biosafety and microbiology panel supporting raw material, in-process, and drug-product release for cell & gene therapy programs. We pair rapid methods for fast, risk-based decisions with compendial methods for regulatory release — all under one quality system, in the same building as manufacturing.
Quantitative LAL-based bacterial endotoxin testing to USP <85> — confirming product is free of pyrogenic contamination across raw materials, in-process samples, and final release.
Automated, continuous microbial-detection sterility testing for faster time-to-result — supporting risk-based release decisions on short-shelf-life therapies.
Compendial sterility testing to USP <71> — membrane filtration for filterable products, direct inoculation for matrices where filtration isn't appropriate.
Rapid PCR-based mycoplasma detection delivering same-shift results — ideal for in-process checks and lot-disposition support.
Microbiological examination of nonsterile products (bioburden) to USP <61> — quantifying total viable microbial load in materials and in-process samples.
Microbial characterization and stain typing, including Gram stain, to USP <1113> — classifying isolates to support investigations and environmental monitoring.
Sending biosafety testing to an outside lab adds weeks of queue time and hand-offs to every lot. Running the panel ourselves means qualified methods ready from day one, samples tested on our cadence, and quality decisions made in the room with the manufacturing team — not across a shipping label.
Tell us about your program and we'll confirm scope, methods, and turnaround — usually within one business day.
The full set of capabilities that make up our integrated CDMO platform.
SynBio research, ML-driven optimization, proprietary tools for next-gen therapies.
End-to-end autologous & allogeneic workflows — CAR-T, NK, Treg, in-vivo GT.
Adherent & suspension lentivirus — 2 L to 200 L GMP. Targeting and control built in.
Knowledge transfer as a discipline. Development-to-GMP in ~7 months.
Dedicated PMO, transparent Gantts, real-time data exchange. One accountable team.
