Navigating Regulatory Challenges in Biologics: A Case Study in Overcoming Clinical Holds

In the intricate world of pharmaceuticals and biotechnology, every step of drug development is meticulously scrutinized by regulatory bodies. For small to medium-sized companies in the field, the journey can be fraught with challenges, especially in biologics development. In this case study, we delve into how Veristat helped a small-sized biotech company overcome a partial clinical hold and smoothly steer multiple products through development.

The Challenge: A Partial Clinical Hold Threatens Progress

Our story starts with a promising biotechnology company working on the mid-clinical development of a novel cell therapy/immunotherapy product platform to treat various types of cancer. However, their journey took an unexpected turn when one of their products was subjected to a partial clinical hold due to critical CMC deficiencies. This partial clinical hold had far-reaching consequences and led to multiple information requests from the FDA for all products within the platform.

Facing this challenge, the biotech company turned to Veristat for guidance and support.

The Solution: Tailored CMC Support by Regulatory Experts

Veristat's regulatory CMC experts provided tailored support to the sponsor, playing a pivotal role in turning the tide.

Thanks to Veristat's unwavering support and expertise, the biotech company was able to move forward from the partial clinical hold. The meticulous attention to detail in the manufacturing and analytical programs ensured that all products across the platform progressed through development without encountering any further clinical delays.

Lessons Learned: Navigating the Complex World of CMC

This case study highlights several crucial lessons for companies venturing into the development of biologics:

• Assays: Developing and validating assays in the early stages may not always cover the range, sensitivity, or robustness required for the variability of a biological product - plan for adaptability and scalability.
• Secondary Methods: Relying on secondary methods to troubleshoot or substantiate a method may not always yield successful results, leading to the invalidation of the original plan. A proactive approach to method development is essential.
• Sensitivity and Load Capabilities: Assays with limited load capabilities and sensitivity should not operate at the lower detection limit, especially in biotherapeutics, where inherent variability is a constant companion.

Navigating the path from concept to approval in the pharmaceutical and biotech industries can be a daunting challenge. However, with the right expertise and strategic guidance, small to medium-sized businesses can overcome these complexities and succeed.

Veristat played a crucial role in helping our sponsor overcome a partial clinical hold and successfully steer multiple products through development. This is a testament to the importance of regulatory CMC expertise and strategic planning in biologics. If you're in the pharmaceutical or biotech industry, this case study is a valuable resource for understanding the nuances of regulatory challenges and how to overcome them.

Download it today and take a step closer to your own success story in biopharmaceutical development.

Learn more 

• Strategic Regulatory Consulting & Planning
• Decentralized Solutions for Patient Enablement
• Natural History Trials for Rare Diseases
• Full-Service Clinical Development Solutions