Malvern Panalytical’s Biopharmaceutical Development Support Solutions

“Which technique should be used to evaluate the sample?”

To be honest, we do not have the correct answer either.

One thing we can say is, “It’s important to assess complementarily using multiple techniques, rather than relying on a single technique.” Therefore, understanding “what characteristics you want to evaluate” with “which technique” is crucial. Furthermore, the number of samples, volume, and resources are also considerations for technique selection.

This document introduces the items that should be evaluated at each stage of biopharmaceutical development and the measuring techniques of Malvern Panalytical that can evaluate them. A feature of our equipment is that it allows measurement in a more natural state without the need for special modifications such as labeling or immobilization. We have aimed to present typical data obtained with each technique in an easily understandable manner. Please utilize it according to the purpose of your research.

Evaluation Items at the Time of Biopharmaceutical Development

Candidate Selection

• Support for exploring indicators for a better construct

Prescription Review

• Support for exploring indicators for better prescription conditions
• Support for evaluating impurities that occur as the manufacturing process progresses

Manufacturing Process

• Support for evaluating impurities that occur as the manufacturing process progresses

Quality Management

• Support for evaluating and managing indicators for formulated products

Biosimilars

• Support for evaluating and managing indicators for biosimilar products

PDF Catalog Download

Download the PDF version catalog with all the information compiled in one (registration on Malvern Panalytical’s website is required).