AGTC expands gene therapy manufacturing capabilities

By The Science Advisory Board staff writers

May 14, 2021 -- Applied Genetic Technologies (AGTC) has initiated plans to lease a build-to-suit 21,000-sq-ft current good manufacturing practice (cGMP) manufacturing and quality control facility in Florida.

The facility will be located adjacently to its existing facility to prepare for anticipated late-stage development of its x-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM) programs.

Build-out of the cGMP facility is expected to be completed in the second half of 2022 and is part of the company's strategy to enable more rapid filing of a biologics licensing application and commercial launch of its XLRP candidate upon potential U.S. Food and Drug Administration (FDA) approval.

Company leaders say the cGMP facility is also expected to support more advancement of the company's product pipeline while providing supply chain redundancy and reducing manufacturing risk.

The company plans to support its cGMP manufacturing and quality control strategic investment through a combination of tenant improvement allowances and tiered rental rates during construction of the facility. It has also authorized a second loan of $10 million.

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