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CDMO SERVICES FOR VIRAL VECTORS & VACCINES

Quality Analytics

You deserve precise and reliable analytics for your viral vaccines and vectors. 

Our team of experts customizes analytical methods to your specific needs, ensuring a seamless transition from vector development to GMP-compliant manufacturing. Benefit from state-of-the-art facilities, integrated teamwork, and a single point of contact for exceptional results.

 

IN A NUTSHELL
The diversity and complexity of virus and viral vector product development is demanding and challenging. Our analytical experts support and secure your candidate's individual analytical requirements with know-how and flexibility. The production and analytics of viruses and viral vectors is combined in our brand-new biosafety level 2 QC labs and GMP facility.
ProBioGen Quality Analytics
HOW WE WORK 

Custom-Fit Analytical Panel 

You can bring a pre-designed virus or just the gene/s of interest and we will adjust the analytical panel to your needs and regulatory requirements. A dedicated QC team supports the analytical development and assumes responsibility for analytical methods to ensure a seamless transition.

Comprehensive Method Package 

We offer a comprehensive method package for testing viral substances ('viral drugs') in-house up to risk group 2 agents with regard to their product-specific properties. Methods for determining the biological or physical titer and detecting transgene expression or PCR-based identity tests are either transferred by you to our laboratory or developed by us. 

Integrated Team Work 

The close cooperation between the QC, process development, and manufacturing teams ensures that your product is optimally monitored from the early development phase until GMP production. 

Virus Expert Team

The QC unit for viruses and viral vectors is located in close proximity to the virus production facility and is used exclusively for analytical services for viral vaccines, ATMPs, and GTMPs. Knowing that these viral products have extremely diverse characteristics, we attach particular importance to individual and product-related analysis. 

Single Point of Contact 

Transfer of methods from your experts or method development by us is followed by phase-specific qualification and validation. We are your single point of contact for any analytical tasks and rely on our extensive capabilities to perform in-house analysis. 

State-of-the-Art Laboratory 

Our newly built biosafety level 2 laboratory, equipped with the latest analytical devices, awaits your product. Beside the standard, compendial QC tests, we quantify physical and biological titer. We also analyze your genes of interest (GOI) and their products, which are characterized using highly-sensitive digital PCR and capillary western blot systems. 

Our Promise To You

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One-Stop-Shop Services

 

  • Combining manufacturing and analytics for viruses and viral vectors on site.
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Know How & Flexibility

 

  • Expertise and adaptability covering the diversity and complexity of virus and viral vector products.
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Integrated Process & Analytical Development
  • Monitoring and control by close-meshed analytical services for virus and viral vector design, USP/DSP process development and GMP manufacturing.

Elevate Your Candidate With The Right CDMO

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