GMP Grade RNA
With decades of experience in RNA production, including GMP certification since 2018, etherna manufacturing provides a full range of RNA production services for all stages of your project.
We support you in process optimization, QC method development, GMP production, stability studies, and can also provide regulatory support.
Based upon our scalable proprietary process, we have established a route to GMP designed to move efficiently through the GMP production process –
this starts with a small scale Research Grade production and progresses through a series of upscaling productions and increasing levels of quality:
Our platform upstream and downstream processes will be used to develop the optimized process for your production, with a view to optimizing all appropriate parameters including RNA yield and stability.
Analytical Method Development
Based upon our established platform methods we will put in place an analytical lifecycle for phase appropriate application. Depending upon factors including choice of buffer and DNA template some tests may need to be developed, qualified or validated.
We can produce to multi g scale and can accommodate your requirements through Phase I to Phase III. Due to the nature of the equipment and processes used there is a minimum quantity that can be manufactured in the clean room – this is typically 500mg.
Drug Substance RNA can be formulated in WFI in order to be further processed up to Drug Product.
We provide Drug Substance filling in 50 ml tubes, AT-Closed vials or through a closed system in sterile bags. Additionally, we offer Drug Product filling in 6ml or 2 ml AT.
RNA from both the Engineering Run and GMP batches are put on stability programs over short term (4 weeks, 3 months) and longer term (typically 36 months). A freeze-thaw stability assessment is also recommended. We will develop a stability program suitable for your application and regulatory requirements.
CMC Regulatory Support
Regulatory support can be provided on request regarding content provision for CMC sections of IMPD/IND documents and responses to questions from regulatory authorities.
Our experts in RNA construct design, production, process development and QC are available to discuss your specific project requirements
Please contact us with any queries or for pricing information.