FDA accepts GMP plasmid DMF: Andelyn now ‘on track’ to speed up gene therapy development

By Jane Byrne contact

- Last updated on GMT

© GettyImages/LuckyStep48
© GettyImages/LuckyStep48

Related tags: plasmid DNA, fermenter, Gene therapy, adeno-associated virus

Andelyn Biosciences says the FDA's acceptance of its GMP plasmid DNA drug master file (DMF) enables the CDMO to vertically integrate its clients’ manufacturing process, condensing timelines for developers to begin manufacturing to just three months.

Most of today’s gene therapies – including adeno-associated virus- and lentivirus-based therapies – depend on plasmid DNA as either a critical starting material or an API. With the rapid growth of the gene therapy development pipeline and massive quantities of plasmid DNA required for the global mRNA COVID-19 vaccination effort, timelines for securing this essential material have escalated dramatically, causing large delays, said the Columbus, Ohio based company.

Gene therapy manufacturers wait, on average, ten months for production, analytical analysis, and release of plasmids. This wait, combined with delays associated with fragmented materials suppliers and CDMOs, often results in a gene therapy commercial manufacturing timeline of approximately 18 months, continued the company.

“The GMP plasmid DMF facilitates a single-source for plasmids allowing Andelyn to get their clients into a manufacturing suite three to four times faster than when disparate materials suppliers are required,”​ Wade Macedone, chief operating officer (COO), Andelyn, told BioPharma-Reporter.

Capacity expansion 

Andelyn began offering research-grade plasmids in 2019 and clinical-grade plasmids in 2021.

While the GMP plasmid DNA offering is key to vertically integrating the complete gene therapy manufacturing process for its clients, the contract development and manufacturing organization (CDMO) said increased production capacity is another factor.

By the end of the first quarter of 2022, the company expects to double its plasmid DNA production capacity and quintuple that capacity by the end of 2023.

Providing more detail on that capacity expansion, the COO said that, by December next year, Andelyn will “house multiple 50L, 200L and 300L fermenters for research, toxicology and cGMP plasmid manufacturing services.”

The company said it will begin operations in its state-of-the-art 185,000 sq. ft. (17,187 sq. m) commercial manufacturing facility, expanding capacity across 16+ production suites for customization of new programs and tech transferred programs, from July 2022.

“Capacity expansions coupled with our clinical-grade plasmid DNA offering allows us to be a fully vertically integrated gene therapy CDMO continuing to contribute to the capacity and capabilities required to advance the gene therapy sector,” ​noted Macdeone.

Related topics: Markets & Regulations

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