FEATURED ARTICLES

• Personalized Cancer Vaccines: The Science Is Ready. Is the Manufacturing?

  Late-stage melanoma data and long-term survival signals in the hardest solid tumors point to a viable personalized neoantigen vaccine strategy, but a fixed biological timeline strains upstream production.

• Pure Synthetic oDNA For mRNA Therapies

  What changes when linearized plasmid DNA is replaced with a synthetic, cell-free template for IVT? Compare performance head to head, from enzyme kinetics to a CEPI-funded vaccine program.

• Why Clinical Operations Is The Bridge To Patient Access

  Autologous cell therapies depend on time-critical supply chains. Automated processing, rapid testing, and centralized data help streamline vein-to-vein delivery and expand access.

• Integrated Vs. Modular CDMO Strategy For Advanced Therapies

  Fragmented manufacturing increases tech transfer risk, delays timelines, and causes data loss. A unified framework preserves continuity and accelerates advanced therapy delivery.

• Scaling MSC Therapies To GMP: The Variability Challenge

  Scaling stem cell therapies hinges on managing biological variability. Learn how automated 3D processing, defined media, and robust analytics drive predictable development.

• DNA Quality As A Manufacturing Variable: What Sponsors Need To Know

  Traditional plasmid DNA manufacturing introduces biological impurities and structural variability that lower viral titers. Transitioning to cell-free synthetic DNA platforms ensures sequence fidelity.

• POSTmark Autologous: The Case For Manufacturing Continuity

  Bridging the gap between early cell therapy development and clinical manufacturing requires operational continuity. Standardizing automated equipment eliminates technology transfer friction.

• CAR-T Manufacturing: Centralized Vs. Hybrid Models

  Choosing between centralized and hybrid CAR-T manufacturing models impacts scalability, logistics, and timelines. Centralized models maximize control, while hybrid networks reduce vein-to-vein times.

• The Manufacturing Reckoning Behind CAR-T's Hottest Race

  In vivo CAR-T scales patient access and cuts timelines but turns biological hurdles into complex manufacturing demands. Precise assays and tight raw material controls are vital for regulatory success.

• How To Choose The Right CDMO

  Advanced therapy manufacturing requires deep biological expertise. Choosing a partner with translational experience and a robust CMC strategy is vital to navigating complex regulatory reviews.

• A Blueprint For Clinical-Grade Gene Therapy Production

  View a scalable, open-access AAV9 manufacturing process improving yield, purity, and consistency through optimized transfection and downstream purification for clinical-grade gene therapy production.

• Plasmid-Free DNA Platform For Better Starting Material

  Optimized synthetic DNA enables scalable gene and RNA therapies with improved stability, expression, and delivery, supporting advanced applications across viral, non-viral, and vaccine platforms.

• Translating Stem Cell Programs To GMP

  A detailed exploration of challenges in advancing stem cell programs to GMP, highlighting strategies to control variability, strengthen process design, and support reliable clinical‑stage manufacturing.

• Viral Vectors: The Backbone Of Cell And Gene Therapy

  Viral vectors are the indispensable backbone of genetic medicine. Learn the fundamental trade-offs and manufacturing strategies for large-scale production of AAV and lentiviral delivery systems.

• Risk To Readiness: Smart CMC Strategy Defines Advanced Therapy Success

  Early, phase-appropriate CMC planning is critical for advanced therapy success. Proactively managing regulatory risks and applying Quality by Design principles secures a clear path to market.

• Delivering Therapies Without Delay Using An Integrated Platform

  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.

• Know Your Product, Know Your Path: A Primer On Advanced Therapy Development

  To prevent path-to-market setbacks, it is critical to develop a Chemistry, Manufacturing, and Controls strategy that proactively identifies scientific and compliance gaps, as well as mitigates risk.

• From Research To Reality: Overcoming CMC Challenges In Cell & Gene Therapy

  Explore the importance of adopting a Quality by Design (QbD) approach in the development process while integrating regulatory and CMC strategies for maximum efficiency and benefit.

• Integrating Analytical Method Development And Quality Control

  As cell and gene therapies continue to advance, a well-integrated analytical framework will be critical for accelerating development timelines and optimizing regulatory submissions.

• Getting Tech Transfer Right First Time

  By adopting unified digital platforms, implementing standardized data models, and enabling seamless system integrations, see how established continuous digital threads can enhance connectivity.