Andelyn Biosciences, Inc.
Andelyn Biosciences is a full-service gene therapy CDMO dedicated to advancing healthcare through innovative research, manufacturing, and collaboration. Originating from Nationwide Children's Hospital, it specializes in viral vector manufacturing, process development, analytical services, and GMP production, supporting the entire spectrum from preclinical to commercial gene therapy development. The company is committed to quality, regulatory excellence, and community engagement, with a rich history of pioneering gene therapies and a mission to turn hope into reality.
Industries
Nr. of Employees
medium (51-250)
Products
Modular AAV manufacturing platform
Configurable AAV process platform that applies data-driven optimization and standardized materials to produce reproducible, high-yield AAV processes tailored to program requirements.
Clonal HEK293 suspension production cell line
Clonal HEK293 suspension cell line developed to improve recombinant AAV yields across multiple serotypes, optimized using DoE for cell density and transfection parameters.
Modular AAV manufacturing platform
Configurable AAV process platform that applies data-driven optimization and standardized materials to produce reproducible, high-yield AAV processes tailored to program requirements.
Clonal HEK293 suspension production cell line
Clonal HEK293 suspension cell line developed to improve recombinant AAV yields across multiple serotypes, optimized using DoE for cell density and transfection parameters.
Services
GMP viral vector manufacturing services
End-to-end GMP manufacturing for viral vectors across clinical and commercial scales, including upstream, downstream, fill/finish, and GMP QC release testing.
GMP plasmid DNA manufacturing services
Production of plasmid DNA at research, toxicology and GMP grades with cleanroom manufacturing, single-use workflows, in-house QC panels, bacterial MCB production and regulatory filing support to secure plasmid supply.
Process development and optimization
Upstream, downstream and formulation development using QbD and DoE, scale-up/scale-down correlation, feasibility studies and yield optimization to prepare processes for GMP transfer.
Analytical development and GMP quality control services
Method development, qualification, validation, stability testing, in-process analytics and GMP QC to support IND and later-stage regulatory filing requirements, including sequencing-based identity and device compatibility testing.
Technology transfer services
End-to-end transfer for analytical methods and manufacturing processes including assessments, on-site training, engineering and confirmation runs, and comparability execution to enable reliable GMP production at new sites.
Digital GxP data platform and analytics services
Implementation and integration of validated GxP software (QMS, LIMS, LMS, CMMS) and data integrity practices to enable secure collaboration, electronic chain-of-custody and correlated manufacturing and lab analytics.
GMP viral vector manufacturing services
End-to-end GMP manufacturing for viral vectors across clinical and commercial scales, including upstream, downstream, fill/finish, and GMP QC release testing.
GMP plasmid DNA manufacturing services
Production of plasmid DNA at research, toxicology and GMP grades with cleanroom manufacturing, single-use workflows, in-house QC panels, bacterial MCB production and regulatory filing support to secure plasmid supply.
Process development and optimization
Upstream, downstream and formulation development using QbD and DoE, scale-up/scale-down correlation, feasibility studies and yield optimization to prepare processes for GMP transfer.
Analytical development and GMP quality control services
Method development, qualification, validation, stability testing, in-process analytics and GMP QC to support IND and later-stage regulatory filing requirements, including sequencing-based identity and device compatibility testing.
Technology transfer services
End-to-end transfer for analytical methods and manufacturing processes including assessments, on-site training, engineering and confirmation runs, and comparability execution to enable reliable GMP production at new sites.
Digital GxP data platform and analytics services
Implementation and integration of validated GxP software (QMS, LIMS, LMS, CMMS) and data integrity practices to enable secure collaboration, electronic chain-of-custody and correlated manufacturing and lab analytics.
Expertise Areas
- Viral vector manufacturing (AAV, lentivirus, adenovirus, HSV)
- Plasmid DNA manufacturing and bacterial cell banking
- Process development and scale-up using QbD and DoE
- Analytical development, method qualification and GMP QC
Key Technologies
- Single-use stirred-tank bioreactors (laboratory to multi-hundred-L scale)
- Multilayer adherent culture and fixed-bed bioreactors
- Affinity and ion-exchange chromatography
- Ultracentrifugation for empty/full capsid separation