10.08.26 -- Risk Managing Through The Void Of ATMP Visible Particle Guidance

Pressure and gamma irradiation testing demonstrated consistent, leak-tight connections without re-tightening for stored single-use assemblies.

Aseptic pouching requires specialized mechanical segregation and sterile vacuum handling. Discover how targeted engineering maintains Grade A compliance.

See how orthogonal analytical assays for CD73 content and enzymatic function can serve as critical quality attributes in scalable MSC-EV manufacturing.

Read how holistic training and validation services help manufacturers navigate complex regulatory demands and achieve operational readiness faster.

Delve into the details of several platform technologies currently being developed and implemented to support effective, large-scale production of viral vectors that meet set quality attributes.

Explore a practical guide to selecting filters for bioprocessing applications that are matched to product type, process stage, and performance needs such as virus filtration, clarification, and TFF.

Fixed-bed bioreactors support scalable manufacturing of AAV and oncolytic virus therapies, offering proven process development strategies for successful clinical scale-up.

IoT-enabled smart BMS modernize biopharmaceutical cleanrooms through continuous monitoring, predictive analytics, energy efficiency, and strengthened compliance, enabling safer, more efficient operations.

Applying Quality by Design principles to automated packaging platforms leverages robotics to eliminate manual errors and adapt seamlessly to evolving regulatory requirements.

Advanced electroporation platforms enable reliable, large-scale delivery of complex gene editing tools like CRISPR/Cas9 to improve efficiency in primary T-cell manufacturing.

Modern contamination control links barrier design, bio-decontamination science, and risk-based validation to ensure reliable surface sterility.

Uncover how CD137-based enrichment improves glioblastoma TIL manufacturing by expanding reactive T cell populations, preserving unique clonotypes, and strengthening autologous tumor cell killing.

Fully automated, closed counterflow centrifugation systems streamline the manufacturing of monocyte-derived immunotherapies while maintaining product purity and cell viability.

Single-use strategies and tools are constantly evolving to better serve industry needs, and adept solutions providers can help streamline development with simple, custom adaptations.

Even limited daily pipetting can increase the risk of repetitive strain injuries. Learn ways to improve posture, equipment selection, and workflow design while supporting long-term productivity.