Unlocking Efficiency for mRNA

August 21, 2024 by Basam Barkho

Webinar Recap: Streamlining RNA Drug Product Manufacturing

In the ever-changing mRNA vaccine and therapeutics field, manufacturing of the final drug product is critical. To show how Aldevron works to continuously improve on that process, we hosted the webinar, Streamlining the Path from Discovery to Patient: Simpler RNA Manufacturing.

This webinar featured insights from Aldevron mRNA Enzymes Product Manager Kyle Studey; Senior Director of Product Strategy Nathan Spangler; and Rebecca Young, Senior R&D Scientist, with a focus on the Codex® HiCap T7 RNA Polymerase.

Innovative RNA Polymerase for Efficient Manufacturing
Kyle Studey kicked off the presentation by introducing Aldevron's groundbreaking HiCap T7 Polymerase. This enzyme promises to revolutionize RNA manufacturing by significantly reducing double-stranded RNA (dsRNA) impurities, which are known to induce unwanted immune responses and cytotoxicity.

Studey explained that dsRNA, an immunogenic impurity, can arise from abortive RNA transcripts or loop-back processes during manufacturing. These impurities are critical to remove, as they can lead to inflammation, reduced potency, and other adverse effects.

The traditional methods to eliminate dsRNA involve lengthy chromatography processes, which add complexity and cost. However, the HiCap T7 minimizes dsRNA formation, making these additional purification steps less necessary.

Cost and Time Efficiency
One of the most compelling benefits of the HiCap T7 is its efficiency in capping. This enzyme reduces the amount of clean cap analog reagents needed by up to 62%, translating into substantial cost savings. During early stages of clinical trials or while scaling up, this efficiency can save both time and money, streamlining the path from discovery to patient.

Rebecca Young highlighted the enzyme’s versatility, explaining that it performs consistently across a range of transcript lengths and is compatible with various UTP analogs and modified nucleotides. This adaptability makes it a robust choice for diverse RNA manufacturing needs.

Regulatory Compliance and Safety
Due to increasing regulatory scrutiny around RNA therapeutics, Nathan Spangler emphasized how regulatory bodies are now more vigilant about impurities like dsRNA. The HiCap T7 not only meets but exceeds these regulatory requirements, positioning Aldevron as a leader in safe and efficient RNA manufacturing.

Comprehensive Support and Collaboration
Aldevron's end-to-end mRNA drug product manufacturing services were also a focal point. From master cell bank production to final fill and finish, there is comprehensive support, ensuring each step of the RNA manufacturing process is optimized for cost-effectiveness and safety. Extensive experience with a collaborative approach means that clients are supported through every phase of their journey, from discovery to clinical application.

The Takeaway
During a wide-ranging Q&A session at the end of the webinar, speakers addressed questions about the enzyme’s performance, scalability, and integration with existing manufacturing workflows. As the takeaway, viewers could see that HiCap T7 provides a game-changing opportunity for the RNA manufacturing landscape, offering efficiency, safety, and cost savings.

• Watch the complete webinar on demand
• Visit our Codex^® HiCap RNA Polymerase page
• Have questions on this topic? Contact Basam Barkho
• Have an idea for a topic? Let us know!

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