Andelyn Development Center
The Andelyn Development Center (ADC) is the home of Andelyn’s process development, analytical development, and preclinical manufacturing capabilities.
Facility and Capabilities
The Andelyn Development Center (ADC) is a 42,000-square-foot facility in Dublin, Ohio where we leverage our deep history and expertise in gene therapy, performing the critical work to develop, optimize, and scale up the processes for our clients innovative programs. It is at the ADC where we also perform preclinical analytics and do assay development work, a critical capability to the success of any gene therapy program. Lastly, the performance of program-enabling feasibility studies, yield assessments, and research and tox-grade manufacturing are also performed at the ADC.
For clients requiring the industrialization of their early processes we offer Andelyn AAV Curator™ Platform, and it is at the ADC where the Optimization-By-Design™ work is performed. The ADC can also support the tech transfer of more established processes and analytics.
The Andelyn Development Center hosts our analytical development capabilities, supporting comprehensive testing across raw materials, in process intermediates, drug substance and product, stability, and administration route compatibility.
Technologies
Our upstream development and preclinical manufacturing efforts utilize both adherent and suspension processes. Our suspension processes include flasks, Ambr®, and small-scale single-use stirred-tank bioreactors to 50L and 200L. For adherent processes we have HYPERStack®, CellStack®, and the iCELLis® Nano System.
Our downstream technologies include multiple modalities from affinity and ion exchange chromatography to ultracentrifugation for purification and empty/full enrichment as well as advanced terminal and tangential flow filtration techniques for clarification, diafiltration and final formulation. Process development and preclinical manufacturing are supported by analytical development with technology to quantify, characterize, assess purity and potency of gene therapy vectors. Materials, methods and equipment used at the ADC are identical to those used in our Corporate Center for commercial manufacturing. This provides a more seamless transfer of processes into GMP applications and allows our clients to leverage preclinical data in support of their regulatory filings.