Gene Editing CDMOs with Clean FDA Inspection History

← All Gene Editing CDMOs Best Clean FDA History Commercial Scale
5
CDMOs tracked
5
Fully scored
4
With FDA records
17
FDA inspections
29
EMA/MHRA GMP certs

Gene editing CDMOs support CRISPR, base, and prime editing programs — spanning guide RNA and nuclease (mRNA or protein) supply, delivery (LNP, AAV, or electroporation), and, for ex vivo programs, edited-cell manufacturing.

Because a gene-editing program touches several modalities at once, CDMO selection often hinges on which steps a partner covers in-house versus coordinates. The rankings below score each CDMO on FDA inspections, GMP certification, clinical activity, and capacity.

FDA inspection outcomes across these CDMOs: 10 NAI (no action), 6 VAI (voluntary action), 1 OAI (official action). Leading inspection & GMP sites: Germany (15), United States (15), France (4), Ireland (3), UNITED KINGDOM (3).

Last updated 2026-05-27. Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.

# CDMO Signal Score Quality FDA · GMP Capacity Programs
1
CR
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
 91.7 98.7 7 insp · 11 GMP Limited 0 programs
2
RC
RoslinCT
Edinburgh, UK · Hopkinton, MA
 80.2 98.8 1 insp · 1 GMP Available 0 programs
3
BY
Bayer (Cell Therapy Mfg)
Berkeley, CA
 79.2 86.9 8 insp · 16 GMP — 125 programs
4
CS
Cedars-Sinai Biomanufacturing
Los Angeles, CA
 78.9 100.0 1 insp · 0 GMP — 31 programs
5
GP
Green Phoenix Labs
San Diego, CA
 78.1 100.0 0 insp · 1 GMP — 0 programs
How we score CDMOs →

What to evaluate in a Gene Editing CDMO

Editing components
Confirm supply of guide RNA and nuclease (Cas mRNA or protein) — in-house or sourced — and the quality controls on each.
Delivery modality
In vivo editing needs LNP or AAV delivery; ex vivo needs electroporation and cell handling. Match the CDMO's delivery experience to your approach.
Ex vivo cell manufacturing
For edited cell therapies, evaluate closed-system cell processing and chain-of-identity, as with other cell therapies.
Regulatory track record
Cross-check FDA 483 history and EMA/MHRA GMP coverage — both shown above and on each profile.

Gene Editing CDMOs — Frequently Asked Questions

Who are the top Gene Editing CDMOs?
By CDMO Signal's independent Signal Score, the top-ranked Gene Editing CDMOs include Charles River Laboratories, RoslinCT, Bayer (Cell Therapy Mfg). See the full ranked table above — scored on FDA, clinical, financial, and capacity data.
How many Gene Editing CDMOs have FDA inspection records?
CDMO Signal tracks 4 Gene Editing CDMOs with FDA inspection records and 29 EMA/MHRA GMP certificates across the group.
What should I look for in a gene editing CDMO?
Map the steps you need — guide RNA and nuclease supply, delivery (LNP/AAV/electroporation), and edited-cell manufacturing — and confirm which the CDMO covers in-house versus coordinates, plus a clean FDA and EMA/MHRA record.
Why do gene editing programs use multiple CDMOs?
A single program may need guide RNA, a nuclease, a delivery vehicle, and cell manufacturing — distinct capabilities. Some CDMOs cover several in-house; many programs combine specialists.
Related modalities
Cell Therapy CDMOs AAV / Gene Therapy CDMOs mRNA / LNP CDMOs
Other Modalities
AAV CAR-T Lentiviral Cell Therapy mRNA/LNP Plasmid DNA Biologics Oligo/ASO Adenoviral Exosome Recombinant Proteins ADC