Challenges and Successes of ICH Q12 Related Submissions

Recently investigators have begun to harness new technology such as microfluidic modulation spectroscopy (MMS) to reveal protein structural changes, as a solid understanding of structure and function is extremely important to the effectiveness of biotherapeutic drugs and scientist today are challenged in gathering a complete understanding with current tools. During the biomanufacturing process, proteins such as antibodies, often undergo conformational changes that can alter their secondary structure, leading to critical variations in their overall function. These changes have been historically difficult to detect, as traditional analytical techniques are not great at detecting small differences in protein structure.

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During direct compression tablets are manufactured without pre-granulation. Excipients therefore need to be highly effective, controllable and free-flowing.

The focus on accelerated development of new modalities for advanced therapies and challenges with complex drug candidates has driven the adoption of novel concepts and technologies in pharmaceutical development and manufacturing.