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.
Demand for mRNA continues to rise and earlier this Spring, we announced the expansion of our mRNA custom manufacturing— going from a cell bank to a drug product — to help meet demand. Doing that required combining our capabilities with the technologies and expertise of two other Danaher companies, Cytiva and Precision NanoSystems Inc. (PNI). Genetic Engineering News covered the story, interviewing Todd Howren/ PhD, Aldevron's VP of RNA.
Will offer mRNA cGMP Production from Master Cell Bank to Drug Product Made Possible with Precision Nanosystems and Cytiva
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.
On the pathway to GMP manufacturing in support of clinical trials, multiple technology transfers may correlate to an increase in complexity and risk to both product and timeline. The hand-off of new technologies, protocols, and materials can lead to delays or project failures.
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.
Aldevron, a global leader in the custom development and manufacture of plasmid DNA, proteins and mRNA for the biotech industry, announced today the addition of three reporter Self-amplifying RNA (saRNA) products to its growing catalog: AldGFP saRNA™, AldSEAP saRNA™ and AldnLUC saRNA™.
FARGO, N.D. (February 12, 2019)—Aldevron, a global leader in the custom development and manufacture of plasmid DNA, proteins, mRNA and antibodies to the biotech industry, announced today the addition of DasherGFP® (green fluorescent protein) mRNA to its off-the-shelf, product portfolio.