Aldevron, a global leader in the custom development and manufacture of plasmid DNA, RNA, and proteins for the biotech industry, signed a licensing agreement with Genentech, a member of the Roche Group, to use Aldevron’s proprietary Nanoplasmid® vector technology.
The manufacture and release of mRNA therapeutics and vaccines is a complex and challenging process requiring a high degree of expertise, capabilities, and experience. The development and manufacturing of drug product involves several stages that include production of cell banks, linear DNA, and mRNA drug substance, with lipid nanoparticle (LNP) formulation/encapsulation and analytical testing at all steps, through aseptic fill/finish.
Aldevron, a leading global manufacturer of DNA, RNA and proteins used in cell and gene therapies and vaccine development, will expand its mRNA production capabilities to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities enabling mRNA cGMP manufacturing services from Master Cell Bank through to Drug Product. This new capability will support the production of therapeutic-scale clinical and commercial-stage mRNA therapies for cancers and genetic diseases, and clinical-stage vaccines for infectious diseases.
March 22, 2022
8 am PT, 11 am ET, 16:00 CET
Messenger RNA (mRNA) and self-amplifying RNA (saRNA) unravel new possibilities for the treatment and prevention of diseases. As relatively new therapeutic modalities, both offer advantages: they can instruct the ribosome to make almost any protein, function without entering the cell nucleus, and degrade without leaving behind unwanted or harmful genetic traces. With some of the recent advances in mRNA and saRNA process technologies, we are beginning to realize the true potential of these modalities. Interestingly, saRNA also has the added advantage of lower doses compared to mRNA while getting the same effect (50-100-fold lower in some instances). However, the success of the mRNA/saRNA programs and the path to the clinic depend heavily on the timeline of manufacturing the RNA molecules.
In this GEN webinar, our distinguished speaker Dr. Venkata Indurthi will discuss some of the key upstream and downstream considerations that go into process development for RNA drug substance manufacturing. Moreover, Dr. Indurthi will also present data on the parameters that need construct-specific optimization to increase yield and reduce impurities, in addition to sharing his insights on critical aspects of analytical development to accelerate the path to the clinic.
A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelist.
Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Aldevron, the leading provider of high-quality plasmid DNA, mRNA and recombinant proteins necessary for vaccines, gene and cell therapy, gene editing and diagnostic applications, announced today that Aldevron will support the development of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD), and ARU-2801, a one-time investigational gene therapy for hypophosphatasia (HPP). Aldevron will provide good manufacturing practice (GMP)-grade plasmid for Aruvant’s upcoming ARU-1801 pivotal trial.
Moderna, Inc. (Nasdaq:MRNA), and Aldevron have announced their expanded collaboration in support of the Moderna COVID-19 Vaccine and additional programs in Moderna’s clinical development pipeline. Specifically, Aldevron will supply plasmid DNA to serve as the genetic template for generating the COVID-19 mRNA vaccine and other investigational programs in Moderna’s pipeline.
Aldevron hosted its first Breakthrough Symposium (BTS) in Fall 2018 with an exciting lineup of industry leaders presenting their research and how it affects the present, and the future, of finding solutions to the world’s biggest health challenges.
Aldevron announced today the immediate availability of rep/cap plasmids pALD-AAV2, AAV5 and AAV6 to support AAV viral vector manufacturing. All three rep/cap plasmids are immediately available at Research Grade. Additionally, pALD-AAV6 is immediately available at the GMP-Source® quality level, while pALD-AAV2 and pALD-AAV5 will be made available based on market demand. The plasmids are royalty free for all applications in support of pre-clinical activities through clinical development and commercial production.
