Interested in strategies to streamline your adeno-associated virus (AAV) process development and manufacturing? We invite you to utilize these technical resources and discover how a scalable, end-to-end integrated solutions approach enables viral vector manufacturing, and reduces time to market.
The need for industrialized, cost-effective virus manufacturing platforms is growing rapidly as their usage in precision medicines continues to rise. One of the biggest challenges in bringing these life-changing therapies to patients is the ability to efficiently translate bench-scale processes to commercial GMP manufacturing to produce viral vectors at the scale needed to meet dosage requirements.
Adeno-associated viral vectors are the most frequently used delivery system for gene therapies and the need for more cost-effective and scalable viral-vector manufacturing platforms is growing. Explore how optimizing your process with an end-to-end integrated solution can reduce costs, increase speed to market and get your final gene therapy product within reach of patients.
A key aspect of chemistry, manufacturing, and controls (CMC) documentation for complex biological products is the application of quality by design (QbD) principles: a rationale of quality being achieved by process design rather than relying on final quality testing alone. The work presented here provides a framework to illustrate the concept and initial thoughts on using QbD concepts for gene therapy, specifically adeno-associated virus (AAV) production.
The paper, ‘A Scalability Comparison Between 50 and 500 Liter Stirred Tank Bioreactor for Production of rAAV Viral Vector,’ provides new insights to scaling up production of high-titer and high-quality viral vectors at clinical and commercial scales. Pall’s bioreactors are available up to 2000 L.
Watch this webinar and hear from Exothera’s chief technology officer, Dr. Hanna P. Lesch as she explains their scale-up journey of adding a large-scale, suspension-based manufacturing platform, from upstream through downstream processing of viral vectors of up to 2,000 L.
Solutions
For gene therapy developers, speed-to-market and costs are critical considerations. Learn more about Pall’s scalable, integrated solution platforms that can help you throughout your drug commercialization journey — from development and manufacture, right through to the regulatory approval of AAV-based therapies.
Scalable, Integrated Solutions For Adeno-Associated Virus (AAV) Manufacturing:
For gene therapy developers, speed-to-market and costs are critical considerations.