Defining paths and building relationships
While research into RNA, including mRNA and related derivatives, has been ongoing for almost 50 years, it’s taken the COVID-19 pandemic to accelerate the development of vaccines using this technology. mRNA provides an incredible opportunity to develop new treatments for viral based, genetically driven, or cancerous diseases.
With more than 20 years’ experience manufacturing plasmid DNA, Aldevron has developed proprietary and novel processes, procedures, and methods to manufacture, at scale, quality RNA and its derivatives. We are known in the CDMO sector for providing essential components and steps for RNA production, all under one roof with a single quality system:
- Process optimization
- Cell banks: Research Cell Bank (RCB) to GMP Master Cell Bank (MCB)
- Linear plasmid DNA templates (GMP and GMP-Source®)
- IVT and capping enzymes (ISO 13485 and/or GMP)
- GMP Production: IVT mRNA and capping reactions
- GMP Production: mRNA Purification
- Regulatory support
Experience builds trust
Client expectations are high when partnering with a CDMO. A trusted CDMO partner and open discussion are key ingredients for success. The top objective must be to address a client’s specific needs, delivering a high-quality mRNA molecule manufactured under cGMP at the required scale, and to do so in accordance with the client’s timeline.
There are several factors that can help accelerate timelines, where you can share information with your CDMO early to help expedite the development process, such as:
- What is your therapeutic application and indication?
- What does your molecule look like? Encode poly(A) or enzymatic? Type of cap?
- Early definition of your analytical testing requirement
- What manufacturing scales will be needed from preclinical to commercial stages?
- What are the requirements for mRNA purity?
- What are the tolerances for contaminants and impurities?
Having a CDMO partner with decades of experience in delivering both DNA and RNA drug substances is critically important. Over the past 20+ years, we’ve had the privilege to work with clients around the world. This brings significant value to our clients, including:
- Validated processes and methods for scale-up
- Experienced process optimization capabilities and scientists
- Understanding of regulatory requirements
- Optimization of processes for both long and short mRNA molecules
- Experience with mRNA and saRNA
- Understanding of potential failure modes
An experienced CDMO will be able to guide you through this process, which will define a path with the end in mind, and create a partnership through process optimization, scale-up, cGMP manufacturing, regulatory filings and commercialization.