Viral Vector Services
AAV Production Service
3PBIOVIAN offers a fully integrated AAV production service designed to accelerate gene therapy development from concept to commercial stage. Our GMP-compliant AAV platform ensures safe, consistent, and high-quality vector manufacturing for clinical and commercial applications. With deep expertise in AAV gene therapy manufacturing, we provide reliable solutions tailored to your therapeutic goals and regulatory pathway.
We deliver full development and technical transfer of viral vector manufacturing processes and analytical methods, including automated aseptic filling of BSL2 viral vector products and in-house plasmid production.
Utilize our AAV therapy expertise in adherent and suspension cell cultures.
Our unparalleled end-to-end service solution covers everything from sourcing GMP-grade materials to aseptic filling, clinical labelling, GMP storage, and QP-approved release. Our qualified persons are dedicated to certifying products for clinical use before shipping with full GMP documentation and batch records while ensuring compliance and quality at every step.
Our AAV vector production service combines technical excellence with scalability and reproducibility. We work with multiple AAV serotypes and customized constructs to support a wide range of therapeutic targets. Every process step — from plasmid preparation to downstream purification — is optimized to ensure reliable delivery, potency, and safety of your gene therapy product.
At 3PBIOVIAN, we understand that each gene therapy project is unique. Our comprehensive AAV production services are tailored to your program’s needs, covering cell line development, process design, analytical testing, and GMP manufacturing. Whether you require preclinical material or commercial supply, our flexible CDMO model adapts to your scale, timeline, and regulatory requirements.
Quality is at the heart of our AAV virus production service. We maintain fully validated GMP systems that ensure consistency, traceability, and compliance throughout the production lifecycle. Our expert teams follow robust quality management protocols, providing full documentation and release testing aligned with EMA and FDA expectations. The result: reproducible and high-quality AAV vectors ready for clinical use.
AAV production workflow
3PBIOVIAN viral vector services span from plasmid DNA manufacturing to Qualified Person-approved release of the final labeled Drug Product. We provide reliable AAV vectors certified for clinical use with full GMP documentation and support from Qualified Persons.
Choose our AAVion® platform for robust and efficient viral vector production or leverage our flexible development and GMP manufacturing solutions for a customizable viral vector production workflow.
3PBIOVIAN AAVion® Platform is a robust and reliable platform solution for AAV manufacturing
Read MoreAs a leader in AAV viral vector manufacturing, 3PBIOVIAN provides a complete framework for scalable and efficient AAV production. Our bioreactor-based systems and closed, single-use technologies ensure controlled, contamination-free environments ideal for clinical-grade vector production.
Our AAV manufacturing process is built for precision, efficiency, and scalability. From cell expansion to transfection, harvest, purification, and fill-finish, each step follows strict GMP controls. We apply in-process monitoring and analytics to guarantee consistent vector potency and purity, making our workflows ideal for AAV viral vector manufacturing at any scale.
3PBIOVIAN’s AAV gene therapy manufacturing process is optimized for the production of clinical-grade vectors ready for human use. By combining advanced bioprocessing technologies, quality by design (QbD) principles, and real-time analytics, we ensure that each batch meets regulatory standards for safety, reproducibility, and therapeutic efficacy.
With you all the way…
together, making advanced biologics, and tomorrow’s life-transforming therapies.
We deliver unparalleled end-to-end development and manufacturing services for all protein expression systems and viral vectors, both for Drug Substances and Drug Products, from pre-clinical to clinical development and commercial phases.
We support our customers wherever they are on their journey, from early-stage development to commercialization. We are passionate, precise, and always close, together, making advanced biologics and tomorrow’s life-transforming therapies.
Pre-Clinical
Phase I
Phase II
Phase III
Commercial