CROScout

Cell & Gene Therapy Manufacturing CROs in United States

CROs offering cell & gene therapy manufacturing in United States

15 organizations


Catalent

Featured
Somerset, NJ, USA CDMO

Global leader in drug delivery technologies and development solutions. Catalent provides formulation, development, and manufacturing services for pharmaceuticals, biologics, and consumer health products.

GMP FDA Registered ISO 9001

ABL (Advanced BioScience Laboratories)

Rockville, MD, USA CDMO

Biologics CDMO providing GMP manufacturing of viral vaccines, recombinant proteins, and gene therapy vectors from BSL-2/3 facilities, with particular expertise in infectious disease and oncology.

GMP FDA Registered ISO 9001

AGC Biologics

Seattle, WA, USA CDMO

Global CDMO with 30+ years delivering development and manufacturing for biologics, cell therapies, viral vectors, and mRNA across US, European, and Asian facilities.

GMP Compliant ISO 9001 ISO 13485

Andelyn Biosciences

Columbus, OH, USA CDMO

Gene therapy and viral vector CDMO in Columbus, Ohio, with 20+ years of leadership and 500+ GMP drug substance batches produced for rare and ultra-rare disease programs.

GMP Compliant

Emergent BioSolutions CDMO

Gaithersburg, MD, USA CDMO

US CDMO providing drug substance manufacturing, fill-finish, and device assembly services for biologics, vaccines, and cell/gene therapy products.

GMP Certified FDA Registered

Eurofins CDMO

San Diego, CA, USA CDMO

CDMO division of Eurofins providing process development, analytical development, and GMP manufacturing for biopharmaceutical products including monoclonal antibodies and recombinant proteins.

GMP FDA Registered ISO 9001

FUJIFILM Diosynth Biotechnologies

Morrisville, NC, USA CDMO

Top-tier biologics CDMO offering cell culture, microbial fermentation, and cell and gene therapy manufacturing across US sites supporting 128+ regulatory approvals.

GMP FDA Registered ISO 9001

KBI Biopharma

Durham, NC, USA CDMO

US biologics CDMO providing cell line development, process development, cGMP manufacturing, and analytical services for monoclonal antibodies, recombinant proteins, and gene therapy products.

GMP FDA Registered ISO 9001

Paragon Bioservices (now Catalent)

Baltimore, MD, USA CDMO

Gene therapy-focused CDMO providing viral vector manufacturing for adeno-associated virus (AAV) gene therapies, acquired by Catalent to expand biologics capabilities.

GMP FDA Registered

Precision BioSciences

Durham, NC, USA CDMO

Durham-based CDMO using proprietary ARCUS genome editing technology to develop and manufacture next-generation allogeneic cell and gene therapy programs.

GMP Compliant

Resilience

San Diego, CA, USA CDMO

US-based biomanufacturing CDMO founded in 2020 delivering end-to-end development and manufacturing for biologics, mRNA, and cell and gene therapy across a domestic facility network.

GMP Compliant ISO 9001

SK pharmteco

Rancho Cordova, CA, USA CDMO

Global CDMO with integrated small molecule, biologics, and gene therapy manufacturing including proprietary viral vector platforms across the US, Europe, and Asia.

GMP Compliant ISO 9001

Singota Solutions

Bloomington, IN, USA CDMO

Indiana-based aseptic fill-finish CDMO specialising in small-batch sterile injectable manufacturing for cell therapies, gene therapies, and biologics.

GMP Certified FDA Registered

Vita Therapeutics CRO

Columbia, MD, USA CDMO

Maryland-based cell therapy development company providing iPSC-derived cell therapy manufacturing, process development, and analytical services for clinical-stage gene and cell therapy programs.

GMP Compliant

WuXi Advanced Therapies

Philadelphia, PA, USA CDMO

WuXi AppTec's cell and gene therapy division providing GMP viral vector manufacturing, cell therapy manufacturing, and plasmid DNA production from US and China facilities.

GMP FDA Registered