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Accelerate Biotech Development with Proactive Raw Material Quality Control!


"By analyzing raw material variabilities during process development and GMP manufacturing, we enhance process understanding and robustness."

Karlheinz Landauer            Book Appointment
Founder & CEO of QBDC Austria
We utilize high-throughput systems and DNA methylation analysis to characterize the process and define critical raw materials early. 
This proactive approach reduces costs and resources by avoiding inconsistencies. This results in a comprehensive comparison report detailing potential changes and their impact on product quality. 
A QC testing strategy is developed and implemented, ensuring a stable, high-quality product throughout its lifecycle. 

Facility Output

+20%

Lot to Lot Variability 

-50%

QA Investigations

-50%

Master Raw Material Quality and Achieve Unmatched Product Excellence


    Our collaboration is dedicated to mastering raw material quality, ensuring that your products consistently meet the highest standards. By thoroughly analyzing variations in raw materials during both process development and GMP manufacturing, you are not just enhancing your understanding— you are building a resilient and robust process.

    This proactive approach helps you reduce costs and conserve resources by preventing inconsistencies before they occur. Utilizing advanced high-throughput systems and DNA methylation analysis, you can accurately identify critical raw materials attributes early in the process. ​

    The result? A detailed comparison report that highlights potential changes and their implications on product quality. Additionally, we enable you to develop and implement a robust quality control testing strategy that guarantees a stable, high-quality product throughout its entire lifecycle.

    Together, we can ensure excellence in your products and foster a culture of quality that strengthens your commitment to innovation and reliability.



    Book Appointment


  Enhanced Process Understanding


Identify critical raw material attributes and their impact on product quality. 

Increased Robustness  


Reduce inconsistencies and improve the overall output of manufacturing.

Cost Efficiency 


Minimize expensive failures and reduce labor and time costs. 



CMC Consulting

We ensure compliance with regulatory standards, optimizes product development, and enhances manufacturing processes, ultimately leading to high-quality, safe, and effective biopharmaceutical products.

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Shortened Development Time

By predicting fed-batch experiment outcomes without performing them, we save time and costs, enhance process knowledge, and ensure robust, reproducible processes.

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Scaling and Transfer Comparability

We’ve created a comparison report on potential changes and their impacts on product quality. Ultimately, it equips our clients with the tools to uphold high standards in bioprocessing.

Read More

 

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