New plasmid to reduce cost and timeline for gene therapy manufacturing
Aldevron, the world’s leading contract plasmid manufacturing organization, has announced the immediate availability of an off-the-shelf version of pXX6-80, a common adeno-associated virus (AAV) helper plasmid. The plasmid is designed to reduce the cost of AAV manufacturing and subsequent gene therapy applications, while helping Aldevron’s clients meet regulatory requirements.
AAV manufacturing has traditionally required unique custom batches of helper plasmids. This can be expensive and time consuming. Also, older helper plasmid versions often contain antibiotic sequences that are increasingly unacceptable by regulatory agencies. Aldevron’s new pALD-X80 solves these problems by being immediately and universally available with acceptable plasmid elements.
“Gene therapy has experienced tremendous growth over the last year with the approval of multiple products that dramatically improve life,” said Michael Chambers, Aldevron’s CEO. “We are honored to serve this industry and our clients who are achieving these breakthroughs.” Chambers added that the new pALD-X80 is immediately available for research and GMP applications.
AskBio, in its effort to facilitate relief to life threatening diseases, has collaborated with Aldevron to make its critical AAV production reagent available to the entire research community by providing this reagent to Aldevron to make available. AskBio has used Aldevron for all of its clinical GMP production needs and shares in their objective to provide the best reagents at the most effective prices.
The first use of the pXX6 plasmid in recombinant AAV (rAAV) production was published in 1998 (J. Virol. March 1998 vol. 72 no. 3 2224-2232). rAAV is one of the most popular vectors used in gene therapy clinical development worldwide. To request more information on Aldevron’s pALD-X80, please visit the pALD-X80 information page.
Aldevron serves the biotechnology industry with custom production of nucleic acids, proteins, and antibodies. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from research grade to clinical trials to commercial applications.These products are key components in commercially available drugs and medical devices. Aldevron specializes in GMP manufacturing and is known for inventing the GMP-SourceTM quality system. Company headquarters are in Fargo, N.D., with additional facilities in Madison, Wisc., and Freiburg, Germany.
Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held, gene therapy platform company dedicated to improving the lives of children and adults with rare genetic disorders. AskBio’s gene therapy platform includes an industry-leading proprietary Pro10 manufacturing process, an extensive AAV capsid library, and several therapeutic programs in development. AskBio maintains an expansive portfolio of gene therapy technologies that has been the basis of other AskBio portfolio companies, including Chatham Therapeutics which was sold to Baxter in 2015, to continue the development of gene therapies for Hemophilia, and Bamboo Therapeutics, Inc., which was sold to Pfizer, Inc. in 2016 to continue the development of gene therapies for rare neuromuscular diseases including Duchenne muscular dystrophy. To learn more, visit www.askbio.com.