Gene Therapy Manufacturing Solutions

Andelyn Biosciences supports clients from preclinical concept to commercialization. We have supported 75+ INDs with successful completion of over 400 cGMP clinical batches and over 2000 research grade batches.

As a biopharmaceutical CDMO collaborative partner, we offer our clients capabilities which span preclinical R&D, Viral Vector process and analytical development, small to large scale GMP manufacturing up to 2000L, Fill/Finish and quality release testing. Plasmid manufacturing services for vertical integration, accelerated timelines and optimized production yields are offered at the research, toxicology, Phase I/IIa, and commercial GMP grade.
Partnering with you at every stage of the process.

Clinical Manufacturing

From Phase I/IIa through commercial, Andelyn processes optimize production yields and accelerate timelines with scales ranging from 1L to 2000L.

Process Development

Process development is critical for the success of commercially-viable, safe gene therapy products. At Andelyn Biosciences, we use a set of rigorous process development guidelines like QbD, DoE and process characterization to establish, implement, and improve our manufacturing processes.

Viral Vector R&D

Andelyn Biosciences’ R&D laboratories manufacture research grade and toxicology grade viral vectors that support preclinical and IND-enabling tox studies for our global clients.

Plasmid Manufacturing

Andelyn Biosciences has more than 20 years of experience in plasmid manufacturing, and we possess the capability and capacity to manufacture batches of plasmids in any size depending on client specifications – from small trials to commercial-scale plasmid production.
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Partnering with you at every stage

STARTING THE PROJECT
Development / proof of concept stage
  • Platform Consultation
  • Vector Design
  • Plasmid Design
  • Small Scale Productions
ADVANCING TOWARDS CLINICAL TESTING
Pre-Clinical / Ind Enabling
  • Scaled Research Manufacturing
  • Adherent or Suspension Production Routes
  • Analytical Development
  • IND and Regulatory Support
ENTERING HUMAN TRIALS
Clinical Manufacturing / Phase I/II
  • GMP Manufacturing with QA Oversight
  • Adherent or Suspension Production Routes
  • Enhanced Analytics
  • DMF and Regulatory Support
ACCELERATING INTO THE MARKETPLACE
Phase III commercial
  • Raw Material Testing
  • Product Specific Process and Analytical Validation
  • Fill/Finish/Packaging with Labeling and Serialization
  • Manual & Automated Fill
  • BLA and Regulatory Support
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