FDA Accepts GMP Plasmid DMF and Capacity Expansion
Born out of Nationwide Children’s Hospital, Andelyn Biosciences, a biopharmaceutical CDMO, headquartered in Columbus, Ohio, announced that FDA accepted its GMP plasmid DNA drug master file (DMF). The acceptance enabled the organization to integrate its clients’ manufacturing process, condensing timelines for developers to begin manufacturing to just three months.
For instance, adeno-associated virus- and lentivirus-based therapies depend upon plasmid DNA as a critical starting material or Active Pharmaceutical Ingredient (API). As the gene therapy development pipeline is rapidly growing and huge quantities of plasmid DNA are required for the mRNA COVID-19 vaccination, timescales for securing this important material have surged dramatically, causing huge delays.
The gene therapy manufacturers have to wait for approximately ten months for the production, analysis, and release of plasmids due to restrictions in industry capacity and throughput bottlenecks. So the approximate gene therapy commercial manufacturing timeline extends to 18 months including the delays by fragmented materials suppliers and CDMOs and waiting for production, analysis, and release.
Statement of Wade Macedone, COO of Andelyn Biosciences:
According to Macedone, 18 months is too long for delivering the life-saving gene therapies to the patients. The company’s mission is to provide gene therapies to the patient much faster and enable developers to begin commercial manufacturing in just three months.
Even though the scientific team of Andelyn Bioscienceshas 20+ years of experience working with plasmid DNA, the company started offering research-grade plasmids in 2019 and clinical-grade plasmids in 2021. Now that the FDA has accepted DMF, it will allow the company’s client to leverage significant intellectual property information, increasing speed and efficiency when filing an IND or BLA with the FDA.
While the GMP plasmid DNA will also increase the production capacity. 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.
Statement of Dr. Kristin Heller, Andelyn Biosciences’ Plasmid Manager:
The companies clinical-grade plasmid DNA allows end-to-end manufacture of GMP gene therapies for our clients, and the regulatory filing efficiency created by the DMF adds fuel to the fire. Experienced Quality assurance and quality control teams are already present in the company but the plasmid DNA scale and capacity we are bringing online is game-changing, providing our clients with immediate access to starting materials and product manufacturing.
Macedone further explained that the tremendous expertise and experience made possible by our founding within Nationwide Children’s Hospital have led to rapid growth. However, to achieve the capacity and capabilities urgently required by the gene therapy sector, we needed to increase our production footprint significantly.
“Our new 185,000 square-foot commercial-scale gene therapy manufacturing plant housed within the Ohio State University’s Innovation District is coming online in July 2022, along with the new Andelyn Development Center in Dublin, Ohio, opening in Q2 2022 will do precisely this. 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.”