ATMP · Chain of Identity · Potency
Cell & Gene
Therapy Quality
Leaders in Quality for
the Living Drug
Leaders in Quality for
the Living Drug
A small molecule can be re-made if a batch fails. An autologous cell therapy cannot: the starting material was a specific patient’s cells, the batch is one dose, and the patient may be waiting on it. That single fact reorganizes everything quality means — identity that cannot be confused, potency for a mechanism you may not fully understand, sterility on a product you cannot terminally sterilize, and release on timelines measured against a life. We build and run quality systems purpose-designed for cell and gene therapy, not adapted from small-molecule habits.
For an autologous therapy, the batch record is not a formality. It is the only copy.
The single most important control in cell therapy is knowing, at every instant, that these cells belong to this patient. Chain of identity and chain of custody run the full journey — and a break anywhere is not a deviation, it is a catastrophe.
Apheresis labeled to the patient at source, with identifiers that will travel intact.
Custody transfer to manufacturing, temperature and location logged end to end.
The batch-of-one made in a segregated flow that makes cross-contamination impossible, not unlikely.
Identity, potency, sterility, and safety judged against a clock the patient is also on.
Custody handed back to the treatment center, identity re-verified at every handoff.
The final identity check at the bedside: right cells, right patient, verified before infusion.
Right cells, right patient, verified before infusion — the control that a CGT quality system lives or dies on.
Quality professionals arriving from traditional pharma bring reflexes that quietly fail here. Naming the broken assumption is the first step to building the system that replaces it.
A failed autologous lot may mean the patient has no second chance and no time for a re-collection. Right-first-time is not a slogan; it is the whole design constraint.
Fresh products can expire before conventional sterility results return. Release strategy leans on rapid methods and real-time data, defended in advance with the agency.
For a living cell, “strength” is a biological function, often before the mechanism is fully understood. The potency matrix evolves with knowledge, and regulators expect the plan to say how.
The product would die. Sterility assurance shifts entirely upstream to aseptic process design, environmental control, and closed systems — proven, not filtered in at the end.
Sterility you cannot add at the end has to be built into every step before it.
More CGT programs stumble on potency than on any other CMC question. FDA wants a quantitative measure of biological activity tied to mechanism, ready far earlier than most sponsors plan for. Getting it wrong late is the most expensive mistake in the field.
Start before you’re ready. A matrixed potency strategy — multiple complementary assays — begins in early development, because the commercial assay must be qualified against clinical material you only make once.
Tie it to mechanism. Regulators want the assay to reflect how the therapy is believed to work, not just that cells are alive and countable.
Bridge, don’t restart. As the assay matures, comparability and bridging protect the clinical data you have already generated. We plan that bridge from the first assay forward.
The assay that has to survive from first-in-human to commercial. We plan that bridge from the first assay forward.
From a first academic tech transfer to commercial multi-site supply, the quality obligations scale in both depth and jurisdiction. Six areas where sponsors put us to work.
COI/COC design and the labeling, verification, and IT controls that make a mix-up impossible.
Matrixed assay strategy, qualification, and the bridging that protects clinical data through change.
Contamination control strategy, segregation, and environmental monitoring for products you can’t sterilize.
Moving a living process from academia to GMP, and from one suite to many, without losing comparability.
Rapid-method release strategies and the disposition discipline a shelf life of hours demands.
EU ATMP GMP, FDA 21 CFR 1271 and 610, and the donor-eligibility rules that sit beneath them.
CGT quality cannot be learned from a small-molecule career. Your leads have built quality systems for autologous and allogeneic programs, qualified potency assays under agency scrutiny, and made the release call with a patient on the schedule.
Autologous, allogeneic, viral vector, and gene-edited platforms — each with its own quality physics.
We have designed and defended matrixed potency strategies through IND and toward BLA.
FDA 1271/610 and EU ATMP GMP run in parallel, from one quality system rather than two.
We have carried programs through the clinical-to-commercial wall, where most CGT quality systems crack.
Living-drug quality reaches into strategy, CMC, and validation alike. These are the services most often engaged with it.
The full regulatory strategy for advanced therapies — RMAT, accelerated routes, and global filing.
Explore the Industry →The CMC story a living product must tell, where potency and comparability carry the file.
Explore CMC →Qualifying the suites and closed systems that aseptic living-drug manufacturing depends on.
Explore CQV →Tell us about your therapy, your stage, and where the quality system is straining. We’ll match you with a senior CGT quality lead, with a response within one business day. All inquiries are strictly confidential.
