12.02.25 -- The 9 Fastest-Growing Outsourcing Segments

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.

Dive into the scope of <382> for pharmaceutical closures and the regulatory landscape, which includes new required tests, instrumentation for compliance, and recommendations on implementation.

Teams exploring CNS-targeted gene therapies for Huntington’s disease should consider LETI-101, which uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT.

Citing the dismally few wins for CRISPR/Cas9 and other gene editing systems, one scientist proposes delivering zinc finger DNA-binding peptides using AAV6 vectors.

Observe as experts highlight innovative tools and strategies advancing the safety of gene editing therapies while addressing off-target effects, regulatory demands, and manufacturing efficiency.

CGT developers face rising regulatory challenges around potency, stability, and process control. Find out how proactive planning, expert guidance, and early FDA engagement are key to avoiding delays.

A sponsor’s commitment to impurity control throughout manufacturing is vital to ensuring continuous patient safety. E&Ls, nitrosamines, and PFAS are among the most critical impurities to test for.

President and CSO Ruby Tsai, Ph.D., covers general methodologies for reducing immunogenicity in cell-based therapeutics and highlights a unique approach to overcome immune rejection challenges.

Discover a new potency bioassay using RT-qPCR to assess relative transcription activity, and learn more about the advantages and limitations of transcriptional assays versus reporter gene assays.

Eliminating discontinuity between R&D and cGMP manufacturing, through mirrored environments, accelerates the journey to IND and patient access and bypasses delays in clinical transfer.

Consider how GCLP can integrate ethical and technical standards to ensure reliable, compliant clinical trial data and optimize laboratory operations across sponsors, CROs, and partners.

See how one family managed to get an investigational gene replacement therapy manufactured and approved by the FDA so their daughter could be dosed just 14 months from her diagnosis.

By shortening the time to first-in-human trials and increasing efficiency, learn how this approach is opening new opportunities for therapy developers and expanding global patient access.

Now introducing a ready-to-use, suspension-based platform technology for transient transfection of LVVs that eliminates the need to transition from small-scale adherent processes.

Here, we explain how Alerion™ outperformed standard magnetic methods in T cell recovery, speed, and scalability — achieving higher cell quality with Akadeum’s microbubble technology.

Improved iPBMC manufacturing boosts TIL therapy reliability, safety, and affordability through donor screening, process refinements, and performance-based cell selection.

Revolutionize vaccine development with this self-replicating RNA (srRNA) capable of sustaining protein expression, lowering doses, and offering fewer side effects in next-gen RNA therapeutics.

With over 120 years of combined experience in CGT, our team utilizes know-how and process advancements that were established by our founders and builds upon that for our clients.

Director of Commercial Development, Serat Ali, describes FDBs' Advanced Therapy capabilities, discusses their global facilities network, and provides a capacity update.

Confidently navigate every stage of development with tailored tech transfer solutions backed by AAV expertise. Discover how to de-risk, scale, and optimize your process for high-quality performance.

Gain a comprehensive understanding of the biochemical composition of each vector batch while minimizing product consumption, ensuring efficiency and precision in analysis.