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CDMO SERVICES FOR VIRAL VECTORS & VACCINES

AAV Production

Whether you need a high quality AAV vector for preclinical research or for clinical trials, we can support you with a vector production service to match your needs. As a service provider of viral products, we offer vector design, process development, and manufacturing for research purposes and clinical batch—flexible, efficient, and compliant. 

IN A NUTSHELL

AAV Development and Manufacturing for Gene Therapy and Research

At ProBioGen, we are dedicated to advancing gene therapy and research through the development and production of high-quality AAV (adeno-associated virus) vectors. Our expertise, our cutting-edge technology, and our commitment to quality make us your ideal partner for your AAV vector production.  

We offer flexible, scalable solutions designed to meet the specific requirements of your project, from research and development to clinical trials and therapeutic applications. 

AAV Production services
SERVICE OVERVIEW

Integrated Services on Demand

AAV Vector Design and Development

AAV Process Development

AAV Vector Manufacturing

AAV Technology Transfer

AAV Analytics

FLEXIBLE VECTOR PRODUCTION

Take the Right Pathway to AAV Production

We offer flexible production platforms to generate high-yield AAV vectors. This approach helps us meet the diverse needs of your program. This results in scalable production in suspension culture systems to support projects at different stages of development.
Transient transfection AAV-04-01

Fast Track & Small Scale: Transient Transfection

When to Adopt This Approach: 

This method is widely used due to its flexibility and ability to produce AAV fast and in the short term. It is ideal for preclinical research, proof-of-concept studies, and projects that require rapid turnaround times. Our optimized transient transfection protocols ensure consistent, high-titer vector yields, which helps streamline your research and development workflows.

Production Scale: Preclinical Research Production or GMP-Grade AAV Manufacturing 
For preclinical research, we can already offer scalable AAV production in bioreactors of up to 25L. This provides an efficient and cost-effective solution for early-stage projects that require higher yields than traditional small-scale production methods. We use wave, orbital shaken, and stirred tank bioreactors, depending on the customer's needs. 

Our GMP-compliant facility, currently in development, will include a 200L bioreactor designed for large-scale production, supporting both clinical trials and commercial demands. This scalable solution ensures seamless project progression, from preclinical research to clinical application, while maintaining full regulatory compliance. 

AAV-1-1

Stable Production at Larger Scale: Packaging Cell Line*

When to Adopt This Approach: 

For scalable vector production, we will be able to offer AAV generation through established packaging cell lines in the near future. This approach is preferred for large-scale and clinical-grade projects as it offers batch-to-batch consistency and scalability, making it ideal for high-demand applications and commercial production. 

Production Scale: GMP-Grade AAV Manufacturing 
Our GMP-compliant facility, currently under development, will feature a 200L bioreactor for large-scale production to support clinical trials and commercial needs. With this scalable solution, your project will grow seamlessly, from preclinical research to clinical application, with full regulatory compliance. 

 

*Coming Soon

HOW WE WORK

Quality Drives Outcome

Across Whole Viral Vectors GMP Life Cycle

GMP-Compliance

Capability and Scale

State-of-Art Technologies

Drug Product Filling

All on One Place

THE TECHNOLOGY BEHIND IT

Our Proprietary HEK 293 Cell Line

Our AAV production is powered by our proprietary HEK293 cell line, which has been optimized for growth in suspension in chemically-defined mediums. This ensures a robust, scalable, and high-efficiency production platform for AAV vectors. Our cell line is prepared as a master cell bank (MCB), thereby ensuring a consistent and high-quality source for vector production across all projects, from early-stage research to GMP-grade manufacturing. 

Stable AAV Packaging Cell Line*

We will soon be able to offer a next-generation packaging cell line developed specifically for AAV production. Based on our optimized starter cell line and professional cloning methods including the proprietary DirectedLuck® transposase system, our innovative cell line is engineered to provide exceptional performance, reliability, and scalability, making it an ideal choice for researchers and developers in the biotechnology and pharmaceutical industries.

*Coming Soon

HOW WE PRODUCE IT

Production to Demand

We are proud to offer scalable AAV production in suspension culture systems, supporting projects at different stages of pre-clinical and clinical development:

Preclinical Research Production

For preclinical research, we can already offer scalable AAV production in bioreactors of up to 25 liters, providing an efficient and cost-effective solution for early-stage projects that require higher yields than traditional small-scale production methods. ProBioGen uses therefore Wave, Orbital Shaked and Stirred Tank Bioreactors depending on the customer’s needs.

GMP-Grade AAV Manufacturing

Our GMP-compliant facility, currently under development, will feature a 200 liter bioreactor for large-scale production, supporting clinical trials and commercial needs. This scalable solution ensures that your project can grow seamlessly from preclinical research to clinical application with full regulatory compliance. aaaaaaaaaaaaaa

Streamlined Tech Transfer for AAV Viral Vectors

We also offer seamless technology transfer solutions for AAV viral vectors, tailored to meet your large-scale manufacturing needs. Our experienced project managers lead every step of the process, ensuring a smooth transition from inception to execution. With a hands-on approach and a commitment to excellence, we deliver optimal results and a positive customer experience at any stage.

Time & Cost Efficiency

By utilizing our optimized cell line, researchers can save valuable time and resources, accelerating the pace of their research and development initiatives.

Reliable Performance

Our cell line consistently delivers high-quality AAV vectors, reducing variability and enhancing the reproducibility of experimental results. aaaaaaaaaaa

Regulatory Compliance

Our cell line is developed and manufactured in compliance with regulatory guidelines, ensuring suitability for use in preclinical and clinical applications.

Expert Support

Our team of experienced professionals is available to provide technical assistance, guidance, and troubleshooting support to ensure the success of your AAV production efforts.

Our Promise To You

Time is Money
Do It Your Way

 

  • End-to-end-solution, from development to GMP manufacturing
  • Scalable production variants in accordance with customer needs, including tech transfer options

 

Success
Do It Fast and Get It Stable  aaaaaaaaaaaaaaaaaaaa
  • Transient transfections allow for fast results and rapid turnarounds 
  • Packaging cell lines allow for stable production at larger scalecalable production variants according to customer need, including tech transfer
Asset 18
Meet Scientific and Regulatory Requirements
  • Comprehensive testing, characterization and quality control
  • Wide range of analytical methods

 

Scalable production variants according to customer need, including tech transfer optionssss

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