11.18.24 -- CDER Wants Your Input On Improving Integrated Reviews

Optimize your mRNA production with an advanced IVT process, enhancing scalability, purity, and expression activity for clinically relevant RNA therapeutics.

Sponsors face pressure to balance speed, cost, and quality. Examine the following options for accelerating the delivery of transformative therapies while maintaining safety and upholding efficacy.

Achieve your therapeutic and commercial goals by utilizing a tried-and-tested standardized approach combined with the latest technology and reliable analytics.

Every choice is critical in AAV vector production. Experts share how to make the right choices, from the process and cell line, to off-the-shelf plasmids and qualified analytical methods.

Avoiding the valley of death requires an early understanding of a drug’s proposed development process, as well as the potential pitfalls that could stall that development.

Discover how a proprietary transposase technology works and why it can be beneficial for the development process for the expression of biologics.

Ensuring the safety and efficacy of cell and gene therapy treatments necessitates rigorous quality control. See how an outsourcing partner can help you deliver safe, efficacious therapies to patients.

Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.