Adenovirus (AdV) CDMO Services
At Porton Advanced, we specialize in providing end-to-end Adenovirus (AdV) CDMO services, supporting your projects from early research to commercial production. With our proprietary HEK293-S and HEK293T-S suspension cell systems, advanced purification technologies, and GMP-compliant manufacturing facilities, we ensure high-quality, scalable, and cost-effective AdV production tailored to your needs.
Our Expertise in Adenovirus CDMO Services
Porton Advanced brings together a highly skilled team of AdV vector and CMC specialists, offering deep expertise across all clinical phases (I–III) and commercial production. Our services are designed to meet global regulatory standards, ensuring compliance with both China and US filing requirements.
Main Services :
Adenovirus Production Process
Our AdV production process is designed for efficiency and scalability, ensuring high yields and consistent quality:
1.Upstream Process:
Suspension culture with in-line lysis.
High-titer harvest: ≥4.0×10¹⁰ VP/mL, with IFU/VP ≥5%.
2.Downstream Process:
Two-step purification (Ion Exchange Chromatography + Multimodal Chromatography).
High recovery rates: 50-70% for AdV drug substance.
3.Final Product:
Stable liquid formulations for 2-8°C storage, with a shelf life of at least 18 months.
4.Production Scale：Develop 10-50L upstream/downstream processes，Establish 50L, 200L, and 500L production platforms, Validate CPPs through PD and PC.
Delivery Timeline
We are renowned for rapid development and efficient production, offering customized AdV vector development and shortened production timelines to meet client needs.
- Rapid development of USP and DSP processes for AdV Drug Substance within 8 weeks.
- GMP Production & Release: 3 GMP batches produced and released within 38 weeks (if virus seeds are provided).
- Customize liquid formulations for 2-8°C storage within 6-12 weeks, ensuring being stable for at least 18 months.
Case Study: High Recovery Rate in Downstream Purification
In a recent project, we achieved a total DNA residue removal rate of over 98% and reduced HCD levels to 0.2 ng/mL after aseptic filtration
Why Choose Porton Advanced?
- Fast Delivery: CMC development to GMP production and release completed in an average of 10 months.
- High Quality: High unit productivity (>5×10¹⁰ VP/mL), high recovery rates (50-70%), and extremely low residuals.
- Cost Efficiency: Highly competitive production costs with a With a 70-80% substitution rate of Chinese equipment.
- Proven Expertise: Our viral vector platform has supported multiple projects in obtaining clinical approvals.
- Animal-Free Production: Use of animal-free raw materials to ensure process safety.
- Scalable Platforms: From 10L to 500L, our suspension culture and chromatography purification processes optimize AdV production efficiency.
Get Started with Porton Advanced
Whether you’re in the early stages of research or preparing for commercial production, Porton Advanced is your trusted partner for Adenovirus CDMO services. Contact us today to learn more about our capabilities and how we can support your gene therapy development.