02.23.26 -- Ensuring The Raw Material Data Package Supports Regulatory Filings

Global economic shifts, regulatory changes, and evolving trade dynamics are transforming ATMP logistics, demanding resilient strategies to ensure uninterrupted delivery of advanced therapies worldwide.

Evaluate how fixed-bed bioreactor technology supports both AAV and oncolytic virus manufacturing. This review details process development steps to ensure your scale-up remains efficient and consistent.

With 1,300+ companies active, the CGT sector is moving fast. Examine the infrastructure and innovation needed to sustain this momentum and secure regulatory success in a crowded global market.

Selecting the right expression format requires balancing speed, cost, and titre. Analyze a hybrid approach to optimize product quality while accelerating early-phase development milestones.

The leap to GMP can make or break a therapy. Learn how to navigate this critical transition with quality standards that minimize risk and pave a clear path to clinical success.

In this report, explore concrete examples of projects across a global network that are contributing to the successful achievement of sustainability goals and aspirations.

Explore how gene editing and HLA-F technologies address immune rejection. Review the path toward scalable, allogeneic therapies that reduce the need for patient-specific matching.

Commercial viability starts with early investment in process design. Map out the path through PPQ and CPV activities to ensure a therapy is prepared for the rigors of regulatory submission.

Discover how data-driven strategies and structured RFPs can simplify CRO selection, improve transparency, and ensure the right operational fit. Learn practical steps to make smarter vendor decisions.