03.03.26 -- The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality

Advanced computational methods coupled with bioinformatics can be used to navigate the complexities of bioprocessing by anticipating challenges before they arise.

To meet patient demand, advanced therapy manufacturing processes must be commercial ready. CGT sponsors can mitigate risk and protect viability by partnering with a CDMO that prioritizes scalability.

Watch as our CGT experts explore the evolving landscape of viral vector manufacturing, overcoming production bottlenecks, and the strategies necessary to bring life-changing therapies to more patients.

Discover how an autologous CAR-T platform is addressing challenges in cell therapy manufacturing. A three-day process shortens cycles, improves T-cell potency and durability, and reduces costs.

Develop lower-risk conjugation strategies by incorporating the critical insights we highlight in our review of semi-synthetic versus synthetic linker–payloads and their respective advantages and limitations.

Examine the potential of targeting LILRB2/LILRB4 in cancer immunotherapy by delving into our findings on novel monoclonal antibodies that enhance anti-tumor immune responses.

Uncover the benefits of protein expression, which include speed, simple fermentation regimes, and robust, scalable processes that can be tuned according to the specific objectives of a program.

Stability studies confirm that biopharmaceuticals maintain potency, purity, safety, and quality under defined conditions, supporting patient safety, regulatory compliance, and successful development.

Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies.