Cell & Gene
Therapy
Quality

Leaders in CGT Quality & GMP Compliance

Why CGT Quality Is Different

In Cell and Gene Therapy, Quality Isn't a Department. It's the Product.

For a small molecule, a failed batch is a cost. For an autologous cell therapy, the batch is a patient, often the only dose they will ever get, manufactured from their own cells, with a shelf life measured in hours and a potency no single assay fully captures. Conventional GMP was written for processes you can repeat and products you can quarantine and retest. Cell and gene therapy offers neither. We build the quality systems, oversight, and CMC controls that hold to that standard: phase-appropriate in the clinic, inspection-ready by BLA, and honest about the constraints that make this modality unlike anything the guidance was drafted for.

The Hard Part

Four Constraints Conventional GMP Was Never Written For.

Every quality decision in a cell or gene therapy program runs into at least one of these. Miss them, and a system that looks compliant on paper fails where it matters: at the bedside.

A batch of one.

Autologous products are made per patient. There is no second lot to release instead, no requalification run, no statistical batch history to lean on. Every deviation is adjudicated against a single patient's only dose.

A shelf life in hours.

A fresh cell product can expire before a 14-day compendial sterility test reads out. Release has to rest on rapid microbial methods and in-process controls, not the testing timeline the guidance quietly assumes you have.

A potency you can't fully define.

The mechanism of action is biological and multifactorial. One assay rarely captures it, so potency becomes a matrix of orthogonal methods that has to satisfy a reviewer who has watched the modality fail before.

A supply chain through a patient.

Vein to vein, the product leaves the site, is manufactured, and returns to the same person. Chain of identity and custody aren't paperwork. A mislabel is a fatal event, not a deviation.

Scaling from a single clinical site to a licensed commercial process? The quality gaps surface at exactly the wrong moment.

Talk to a CGT Quality Lead
Capabilities

Quality Leadership Across the CGT Lifecycle.

Six disciplines, run by people who have built and defended them under FDA and EMA inspection: the quality system itself, the CDMOs who execute it, the analytics that release the product, its identity through the supply chain, the controls that keep it sterile, and the operations that keep it moving.

Phase-Appropriate QMS

Quality systems sized to the clinical phase that scale to commercial, and never become the thing slowing the program down.
CDMO & Supply Oversight

Selection, qualification, quality agreements, and person-in-plant oversight of the partners who actually make your product.
CMC, Analytics & Potency

Potency matrices, comparability, specifications, and characterization built to survive a CMC reviewer, not just an internal one.
Chain of Identity & Custody

Vein-to-vein labeling, custody controls, and reconciliation for autologous and patient-specific products where identity is everything.
Contamination Control & Sterility

Aseptic process design, environmental monitoring, and rapid sterility strategy for products that can't wait for compendial tests.
GMP Operations & Data Integrity

Batch release, deviations, CAPA, change control, and data integrity run at the tempo a living drug demands.
Phase-Appropriate QMS

A Quality System Sized to Where You Are, Built for Where You're Going.

The most common failure in early CGT programs is a quality system copied from big pharma that buries a ten-person team in procedure, or one so thin it collapses the moment an FDA investigator asks to see it. Phase-appropriate doesn't mean less rigor. It means the right rigor for the risk, with a clear line of sight to the commercial system you will need at BLA. We design QMS architectures that hold at Phase 1 and scale without a rebuild, so the system grows with the program instead of being torn out and replaced the year before launch.

What We Build

  • Phase-appropriate QMS design for clinical-stage and scaling organizations
  • Quality manual, quality policy, and governance structure
  • SOP architecture and document control people will actually follow
  • Risk management framework aligned to ICH Q9 and product risk
  • Training systems and role-based qualification
  • Quality metrics, management review, and CAPA governance
  • Commercial-readiness roadmap from Phase 1 system to BLA-grade QMS
CDMO & Supply Oversight

Your CDMO Runs the Process. You Still Own the Quality.

Most cell and gene therapy sponsors outsource manufacturing, and the FDA holds the sponsor accountable for everything the CDMO does. That accountability is only real if your oversight is real: a quality agreement that assigns every decision, batch record review that catches what a summary hides, and enough presence on the floor to know how the process actually runs. We stand up and run that oversight, from CDMO selection through routine person-in-plant presence, so a partner's deviation never becomes your inspection finding.

How We Oversee

  • CDMO and CMO selection, technical evaluation, and quality due diligence
  • Quality agreements that assign responsibility decision by decision
  • Batch record review and disposition support
  • Person-in-plant and on-site oversight during critical runs
  • Deviation, OOS, and change-notification management across the interface
  • CDMO audit programs and remediation follow-through
  • Tech-transfer quality oversight and comparability across sites
CMC, Analytics & Potency

Potency Is Where Cell and Gene Programs Get Stopped. Build It to Survive Review.

A CGT potency assay has to measure a biological mechanism that is often incompletely understood, with a product that varies patient to patient, on a timeline that cannot wait. Reviewers know this, and a single potency method with a wide acceptance range is a clinical-hold conversation waiting to happen. We build potency as a matrix of orthogonal, phase-appropriate methods, manage comparability across process changes so a manufacturing improvement doesn't invalidate your clinical data, and set specifications you can defend when the CMC reviewer asks exactly how you landed on them.

What We Establish

  • Potency strategy: a matrix of orthogonal, mechanism-relevant methods
  • Phase-appropriate specification setting and justification
  • Comparability protocols across process and site changes
  • Analytical method qualification and validation planning
  • Characterization and reference-standard programs
  • Stability design for short-shelf-life and cryopreserved products
  • CMC sections for IND, IMPD, and BLA quality modules

An FDA pre-approval inspection is scheduled and the quality system has never been tested at commercial scale? That gap closes now, not in the response letter.

Request an Inspection Readiness Review
Chain of Identity & Custody

For an Autologous Product, a Mislabel Is a Fatal Event, Not a Deviation.

An autologous therapy travels a loop no other drug does. It starts as one patient's cells, leaves the treatment site, is manufactured, and comes back to that same patient, and it must be the same patient, verified at every handoff. Chain of identity and chain of custody are the controls that guarantee it, and they are exactly what an FDA investigator probes first for a personalized product. We design the labeling, custody, and reconciliation systems that make a misidentification structurally impossible, and prove they hold under audit.

Controls We Design

  • Chain of identity (COI) framework for autologous and patient-specific products
  • Chain of custody (COC) across collection, manufacturing, and administration
  • Vein-to-vein labeling and unique-identifier systems
  • Custody handoff verification and reconciliation
  • Cryogenic storage, shipping, and logistics quality controls
  • Apheresis and collection-site qualification and training
  • Traceability aligned to FDA and EU tissue and ATMP requirements
Contamination Control & Sterility

You Can't Terminally Sterilize a Living Cell. So Everything Else Has to Be Right.

A cell therapy cannot be sterilized at the end. The product is alive, and the process has to keep it sterile from the first open manipulation to final fill. That puts the entire burden on aseptic process design, environmental control, and a sterility strategy that can release a product before a compendial test would even read out. We build contamination control strategies around how the process is actually run, design environmental monitoring that detects excursions instead of just documenting them, and qualify rapid microbial methods so a short-dated product can be released safely and on time.

How We Control It

  • Contamination control strategy per Annex 1 and FDA aseptic guidance
  • Aseptic process design and open-manipulation risk reduction
  • Environmental monitoring program design and trending
  • Rapid microbial and rapid sterility strategy for short shelf life
  • Aseptic process simulation (media fill) design and review
  • Cleanroom classification, qualification, and gowning programs
  • Mycoplasma, endotoxin, and adventitious-agent testing strategy
GMP Operations & Data Integrity

The Systems That Release Every Batch, at the Tempo a Living Drug Demands.

A short-dated product doesn't give you a week to investigate a deviation or a month to close a CAPA. Batch release, deviation handling, change control, and data integrity all have to run faster and cleaner than a conventional biologic allows, without cutting the corners an investigator will find. We build and run the operational quality systems that release product reliably under time pressure, and the data-integrity controls, from paper batch records to automated systems, that make sure the record tells the truth the first time.

What We Run

  • Batch disposition and release under a time-pressured shelf life
  • Deviation and OOS investigation with real root cause, fast
  • CAPA programs that close and stay closed
  • Change control that keeps pace without losing rigor
  • Data integrity and ALCOA+ across paper and electronic records
  • Computer system validation for manufacturing and QC systems
  • Product quality review and continued process verification
How Quality Scales

Phase-Appropriate, From First-in-Human to Commercial Supply.

The quality system that clears a Phase 1 IND is not the one that survives a pre-approval inspection. The art is building each stage so the next is an extension, not a teardown. Here is how the rigor scales as the program does.

1
Preclinical & IND

Establish the foundation

Core QMS, GMP-ready documentation, and a potency and comparability strategy defined before the first patient, so nothing has to be reconstructed later.

2
Phase 1–2

Prove it in the clinic

Phase-appropriate controls, CDMO oversight, and chain of identity that hold under an early FDA look without burying a small team in procedure.

3
Pivotal

Lock the process

Process validation readiness, comparability across changes, and specifications tightened toward commercial acceptance criteria while data is still being generated.

4
BLA & PAI

Survive the inspection

A commercial-grade QMS, validated systems, and an inspection-ready story across every site, rehearsed before the FDA investigator arrives, not during.

5
Commercial

Hold the standard

Continued process verification, lifecycle management, and the oversight that keeps a licensed, patient-specific product in compliance at scale.

Adjacent Capabilities

When the Stakes Concentrate.

Two moments put a CGT quality system under maximum scrutiny: a real FDA or EMA inspection, and the diligence that precedes an acquisition or a major raise. Both reward preparation and punish improvisation.

Inspection & BLA Readiness

The Inspection Is Won in the Six Months Before It.

A pre-approval inspection for a cell or gene therapy is unforgiving. The investigator has seen the modality fail, knows exactly where the weak seams are, and is reading your data integrity, your comparability, and your CDMO oversight all at once. We run mock inspections that simulate the real thing, remediate what they surface, and prepare the people and the story before the FDA arrives, so the inspection confirms a system that already works instead of stress-testing one that doesn't.

Included Capabilities

  • Mock FDA and EMA inspections simulating a real pre-approval inspection
  • PAI readiness planning and remediation
  • Data-integrity assessments across paper and electronic systems
  • Storyboard and narrative preparation for the quality system
  • SME and management inspection training and defense
  • Form 483 and Warning Letter remediation and response
  • Post-inspection commitment tracking and closure
Diligence & Quality Remediation

Before the Deal Closes, the Quality System Gets Read Cover to Cover.

In a CGT acquisition or financing, the quality and CMC system is diligenced as hard as the clinical data, because a hidden comparability problem or an unqualified CDMO can erase the value the deal was priced on. We run quality and CMC due diligence for acquirers and investors, and remediation for companies preparing to be diligenced, finding the gaps on your terms before someone else finds them on theirs.

Included Capabilities

  • Quality and CMC due diligence for acquirers and investors
  • Sell-side readiness assessment and gap remediation
  • CDMO and supply-chain risk evaluation
  • Comparability and data-integrity risk assessment
  • QMS integration planning post-acquisition
  • Remediation roadmaps sized to deal and filing timelines
Who You're Working With

Quality Leaders Who Have Built and Defended CGT Systems, Not Just Advised on Them.

Cell and gene therapy quality is learned on the floor and in the inspection room, not from a template. Our team has held senior quality and CMC roles inside CGT developers and CDMOs, and stood in front of FDA and EMA investigators when it counted.

Operators, Not Bystanders

Consultants who have been the Head of Quality, the Qualified Person, and the person-in-plant. They have released product under a shelf-life clock and owned the outcome, not just written the SOP.

Both Sides of the Table

Experience from inside CGT sponsors and the CDMOs that serve them, so oversight is designed the way an experienced partner will actually respond to it.

Inspection-Tested

People who have led sites through pre-approval inspections and remediated Form 483s, and know which findings end a launch and which are noise.

Full Modality Range

CAR-T, TIL, and other autologous cell therapies; AAV and lentiviral gene therapy; gene editing; and allogeneic and iPSC-derived platforms.

Work With Us

Bring In Senior CGT Quality Before You Need It.

Tell us where the program stands: first IND, scaling to pivotal, preparing for a BLA inspection, or diligencing a deal. We'll match you with a senior cell and gene therapy quality lead and respond within one business day. All inquiries are strictly confidential.

Schedule a Call Send a Detailed Inquiry
Insights & News

Perspectives on Cell and Gene Therapy Quality.

Our team's views on phase-appropriate quality, potency strategy, and what FDA investigators actually flag in a CGT pre-approval inspection: coming soon. In the meantime, reach out with a question you'd like us to address.

Coming Soon

Phase-Appropriate Quality Without the Rebuild

Designing a Phase 1 QMS that scales to commercial instead of getting torn out before launch.

Coming Soon

The Potency Assay Conversation With FDA

Why single-method potency stalls programs, and how orthogonal matrices clear review.

Coming Soon

What a CGT Pre-Approval Inspection Actually Tests

The seams FDA investigators probe first in a personalized-product process.