AGTC Announces Expansion of Manufacturing and Analytics Capabilities to Advance Commercialization of Gene Therapy Product Candidates
UF startup and UF Innovate | Sid Martin Biotech alum Applied Genetic Technologies Corporation (AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, announced that it has initiated plans to lease a build-to-suit 21,000 square foot current Good Manufacturing Practices (cGMP) manufacturing and quality control facility adjacent to its Florida facility to prepare for anticipated late-stage development of its X-Linked Retinitis Pigmentosa (XLRP) and Achromatopsia (ACHM) programs. Build-out of this cGMP facility, which is expected to be completed in the second half of 2022, 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 United States Food and Drug Administration (FDA) approval. The cGMP facility is also expected to support the more rapid advancement of the company’s product pipeline while providing supply chain redundancy and reducing manufacturing risk.
“This manufacturing build-out reinforces our commitment to the advancement of our XLRP candidate through a Phase 2/3 clinical trial and, if approved, eventual commercialization. We are taking steps to increase control over our cGMP manufacturing and analytical release to ensure that we can meet anticipated future demand for our current clinical candidates and our exciting pre-clinical opportunities,” said Sue Washer, president and chief executive officer of AGTC. “This state-of-the-art manufacturing facility will provide us with the flexibility to pursue additional indications that have large patient populations and/or require substantially higher doses to provide efficacy.”
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