Aldevron News: Clinical Grade Manufacturing/cGMP

mRNA/saRNA Manufacturing Webinar: Considerations to Accelerate the Path to Clinic

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.

Watch On Demand

Read More

In the News: AavantiBio and Aldevron Announce Strategic Partnership to Develop Next Generation Gene Therapies for Rare Genetic Diseases

AavantiBio, a gene therapy company focused on transforming the lives of patients with rare genetic diseases, and Aldevron, a global leader in the custom development and manufacture of plasmid DNA, proteins and mRNA for the biotech industry, today announced a long-term strategic partnership for the supply of plasmid DNA that will enable AavantiBio to advance its platform of innovative gene transfer therapies.
Read More

In the News: Aruvant Partners with Aldevron to Provide Key Plasmid Raw Materials Used to Manufacture Pipeline Products

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.

Read More

In the News: Moderna and Aldevron Announce Expanded Partnership for mRNA Vaccine and Therapeutic Pipeline

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.

Read More

In the News: Aldevron Now Offering AAV Rep/Cap Plasmids For Viral Vector Production

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.

Read More

In the News: Pharma's Almanac - The Pivotal Role of Plasmid DNA

Plasmid DNA was key to the development of biologic drug manufacturing. Today, it plays a critical role in the production of next-generation cell and gene therapies and vaccines. With its plasmid DNA manufacturing expertise, Aldevron has helped facilitate the advance of these important therapeutics. The company continues to invest in additional capacity and novel capabilities to support biopharma manufacturers into the future.

Read More