New Comparability Testing Method for Superior Product Quality

"We analyze multiple data sets from the original process using microarray technology to establish a robust foundation for technology transfer. "

Karlheinz Landauer Book Appointment
Founder & CEO of QBDC Austria

Our collaboration is driven by the need to ensure the highest standards in bioprocessing.

By leveraging our advanced process analytical technology, we aim to enhance comparability testing, which is crucial for maintaining product quality and consistency.

The result is a comprehensive comparison report detailing potential changes and their impact on product quality.

Tox Studies

only once!

Time to Market

- 50%

Conformation Runs

- 3

We team up to uphold top-notch bioprocessing standards.

By using QBDC's advanced analytical technology, we improve comparability testing, which is essential for product quality and consistency.

By utilizing cells as sensors, we monitor processes and enable comparisons across different runs, sites, and process changes. Using QBDC's advanced analytical technology, we enhance comparability testing, which is crucial for maintaining product quality and consistency.

We analyze at least three data sets from the original process using microarray technology. This foundational work supports seamless technology transfer, allowing us to compare updated processes, assess changes by analysing the cells, and determine corrective actions. We also examine DNA methylation in cells from both original and transferred processes.

You receive a detailed comparison report outlining changes of cell DNA methylation and their effects on product quality. This facilitates quicker corrective actions and a deeper understanding of the process, leading to improved product quality. Ultimately, we provide biotech technicians with the insights they need to ensure high product standards and excel in bioprocessing.

Book Appointment

Enhanced Process Understanding

Gain deeper insights into cell regulation and in the context of potential effects on product quality and bioprocess parameters

Improved Product

Quality

Ensure comparability and consistency in product quality across scaled or transferred processes

Efficient Corrective

Actions

Quickly identify and address process-related issues to maintain high product standards.

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.

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.

Control of Product and Raw Material Quality

We utilize high-throughput systems and DNA methylation analysis to define critical raw materials early. This proactive approach reduces costs and resources.