09.29.26 -- In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies

Overcoming downstream AAV bottlenecks requires standardized platforming. Data-driven CMC systems accelerate program speed, reduce costs, and strengthen clinical viability for advanced gene therapies.

Key quality parameters dictate recombinant trypsin performance in biomanufacturing. Clarify essential features to strengthen raw material selection and ensure reliable processing outcomes.

Navigating PFS selection requires balancing complex regulatory requirements and supply chain logistics. Adopting an integrated system approach provides unified data and streamlined documentation.

A two-dimensional LC/MS strategy improves the separation of coeluting oligonucleotide impurities. High-resolution sampling and automation enable deeper characterization of low-level variants.

Explore how controlled-rate, directional freezing maintains functional recovery even with lower DMSO concentrations, supporting consistent manufacturing outcomes and enhanced batch reproducibility.

Targeted LNPs that bypass the liver and home to the spleen could reshape in vivo CAR T cell manufacturing. See the data behind the approach.

Rigorous multi-cycle stress testing and environmental validation ensure manufacturing hardware delivers uncompromising reliability for critical processing workflows.

Enable efficient, low-toxicity genome editing without viral vectors. This cell-free circular ssDNA platform preserves stem cell fitness while supporting scalable manufacturing.

Automated labeling integration ensures high-speed accuracy across vertical and horizontal form fill and seal packaging. Modern equipment designs eliminate common drug packaging throughput bottlenecks.

De-risk bioprocess scale-up with application-focused workflow validation. Discover strategies for transitioning therapies from R&D to clinical production.

AAV lot release testing evolves from bulk harvest through drug product release to guarantee safety, purity, and potency. Structured testing strategies ensure compliance and consistency.

Advanced therapies need bioanalysis partners built for complexity, not scale. CGT expertise, specialized platforms, and flexible timelines ensure dosing and safety data traditional CROs can’t support.

DIN values offer a data‑backed way to identify which DNA samples are ready for successful sequencing. With strong correlations to sequencing performance, DIN thresholds help streamline workflows.

Uncover how site-specific fluorescent labeling addresses key challenges in flow cytometry-based evaluations by enhancing assay sensitivity, reducing variability, and ensuring reliable results.

Learn how to implement PAT effectively with a roadmap that covers techniques, validation, data integrity, and lifecycle strategies to help teams improve quality, control, and productivity.