Unlock high yield and high purity for large-scale gene therapy manufacturing with Thermo Fisher Scientific’s integrated CaptureSelect™ and POROS™ technologies.
Section 1: The Need for Scalable, High-Quality AAV Production
As the gene therapy landscape rapidly evolves, the demand for scalable, high-quality viral vectors—especially Adeno-Associated Viruses (AAV)—has never been greater. These viral vectors are essential for delivering DNA to target cells and are pivotal for the successful treatment of rare diseases. However, scaling production to meet increasing clinical and commercial needs presents significant challenges.
Key Challenges in AAV Manufacturing:
- Ensuring high yield and purity for therapeutic efficacy.
- Meeting regulatory standards for viral clearance and safety.
- Scaling up production while maintaining efficiency and cost-effectiveness.
With the FDA projecting 10 to 20 gene therapy approvals per year by 2025, the need for efficient and scalable viral vector production is more pressing than ever.
Section 2: Addressing Viral Clearance in AAV Production
Viral Clearance: A Crucial Step for Safety
In gene therapy manufacturing, ensuring that all potential viral contaminants are eliminated is paramount. Regulatory bodies like the FDA and ICH Q5A emphasize the need for effective viral clearance methods to ensure the safety of gene therapy products. Thermo Fisher Scientific’s advanced viral clearance solutions, through the use of CaptureSelect™ and POROS™ technologies, provide robust viral clearance even under challenging manufacturing conditions.
Key Features of Our Approach:
- Validated Viral Clearance: Proven performance, even under “worst-case” conditions.
- High Specificity: Minimal to no non-specific interactions with AAV capsids or viruses.
- Scalable Process: Ensuring safe and efficient viral vector purification at large scale.
Section 3: Simplifying AAV Purification with CaptureSelect™ and POROS™ Technologies
Affinity Chromatography for the Next Generation of Gene Therapy
Thermo Fisher’s integrated CaptureSelect™ and POROS™ technologies transform AAV purification by providing a simplified, cost-effective process that doesn’t compromise on yield or purity. These affinity chromatography platforms utilize specific ligands coupled with a solid support to efficiently capture viral vectors from crude material.
Advantages of Our Affinity Chromatography Solution:
- High Purity and Yield: Achieve one-step purification with minimal complexity.
- Specificity for AAV Serotypes: POROS™ CaptureSelect™ AAVX affinity resin provides high specificity for various AAV serotypes, including AAV8 and AAV9.
- Reduced Development Time: Faster process development and higher yields compared to traditional methods.
Section 4: Proven Success in Large-Scale Manufacturing
Our technologies have been validated in real-world applications, demonstrating the ability to provide consistent, high-quality AAV vectors for gene therapy production.
Real-World Impact:
- Increased Yields: A major end user saw significant improvements in yield and a reduction in process development time by switching to POROS™ CaptureSelect™ AAVX affinity resin.
- Enhanced Viral Clearance: Successful viral clearance achieved even under non-ideal processing conditions.
By optimizing the purification process, we help you scale production without sacrificing quality, ensuring that gene therapies meet the high standards required for clinical and commercial use.
Section 5: Why Choose Thermo Fisher Scientific?
Thermo Fisher Scientific has been at the forefront of innovations in biotechnology. With our expertise in affinity chromatography and viral vector purification, we offer solutions that ensure efficient, high-quality manufacturing for gene therapies.
Our Expertise Includes:
- Comprehensive solutions for viral vector production.
- Proven track record in viral clearance and high-yield purification.
- Ongoing innovation to meet the evolving needs of the gene therapy industry.
This article is posted at thermofisher.com
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