The widespread use of pDNA in cell and gene therapy (CGT) is driving increasing demand—and it’s no surprise it was one of the hottest topics at recent events including the recent BioProcess International (BPI) conference, what’s known as the largest bioprocessing event in the world. Sessions covering topics as diverse as cell and gene therapy, manufacturing capacity to meet demand and digital transformation addressed how CDMOs are accelerating (pDNA) plasmid DNA manufacturing.
Plasmid DNA is the foundation for all advanced nucleic acid-based gene therapies and vaccines under development. While the requirements for release of plasmids used in CGTs are continually evolving, suppliers should be aware of the growing effort to standardize plasmid release specifications. In fact, the EMA has provided specific guidance: plasmids should be made using GMP conditions to ensure a lower risk of cross-contamination during production.
Additionally, the U.S. Pharmacopoeia has formed a panel to draft standard protocols for plasmid release specifications for use of pDNA as starting materials in the production of CGTs. A recent report by BioPhorum recommends unique plasmid testing measures (e.g., identity testing and cross contamination, appearance testing, and testing for DNA homogeneity), stability studies, and protections against extractable and leachable impurities.
The efforts by multiple bodies to introduce common standards and effective protocols should enable communication and cooperation across the biopharmaceutical industry and simplify communication with regulators. Most importantly, these efforts will lead to continued growth in the use of pDNA as a tool in CGT.
As regulatory expectations continue to evolve, sponsors and manufacturers must ensure that the quality systems that support the manufacture of plasmids and release specifications meet these expectations and requirements—BioCina included.
BioCina is a contract development and manufacturing organization (CDMO) that specializes in the quality production and supply of bulk plasmid DNA in three grades: R&D-grade, non-GMP-grade (highly documented), and GMP-grade plasmid DNA. These offerings cover preclinical to commercial use, and all three grades are supplied as non-sterile bulk DS (drug substance) or API (active pharmaceutical ingredient).
BioCina’s Australian operations have a rich history and demonstrated experience in manufacturing pharmaceutical products for highly regulated markets around the globe. This experience allows BioCina to provide its clients with cGMP pharmaceutical-grade pDNA throughout the product lifecycle from discovery to the clinic to commercialization.
Our intermediate-grade non-GMP/highly documented plasmid is particularly important to therapy and vaccine developers. It bridges the gap between discovery (where R&D grade is sufficient) and commercial (where GMP grade is required). This intermediate grade is designed to provide plasmid for use as a raw material in a GMP process, such as for GMP virus production or toxicology studies.
BioCina has successfully performed multiple technology transfers and developed unique solutions to address technical issues for client programs. We strive to provide all clients with high-quality, cost-effective microbial process development and plasmid DNA manufacturing solutions worldwide.
Get in touch with BioCina to discuss your plasmid DNA needs.