Newsletter | October 10, 2024

10.10.24 -- Gene Therapy CMC Experts On Late-Stage Process Changes

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Gene Therapy CMC Experts On Late-Stage Process Changes

At the 2024 Bioprocessing Summit, a panel of CMC experts spoke about the challenges commercializing gene therapies, specifically focusing on considerations for late-stage process changes.

Improving Scalability And Manufacturing Capacity

Due to the bespoke nature of autologous CAR-T manufacturing, facilities can only produce so many therapies at once. Our panelists discuss these challenges and the need for innovative solutions.

Manifolding For Scale-Up, Safety, And Speed

The use of manifolds to fill bags for bioprocessing or advanced therapies contributes to time savings, improved process quality, and optimal use of cleanroom and personnel resources.

Selecting CGT Manufacturing Processes For Automation

Informing automation decisions involves pinpointing crucial processes for successful batch productions. Prioritize automating processes with the highest risk of human error and the greatest labor cost.

Strategies For The Separation And Analysis Of Empty And Filled Capsids

Explore approaches for the capture and separation of capsids, upstream strategies for reducing the level of empty and partially filled capsids, trends in AAV capsid design impacting purification, and more.

Characterizing Stopper Extractables And Leachables For Drug Stability

The significance of extractables and leachables (E&L) testing lies in its ability to identify potential risks associated with the use of containers and packaging materials in the pharmaceutical industry.

Overcoming Challenges In CGT Development

Consider these connector solutions for sterility, chemical compatibility, and ultra-low temperature challenges when setting up a therapeutic process for long-term success.

Data-Driven CHO Bioprocess Optimization And Scale-Up

Learn how at-line cell culture media analysis enhances mAb production by refining nutrient feed strategies, reducing toxic metabolites, and improving yields while lowering costs.

Automated Cell Washing, Formulation In CAR T Cell Manufacturing

Review data collected from a study utilizing healthy donors in a typical CAR T cell processing workflow without a transduction step from a cross-site validation study.

AAV Manufacturing Process Scale Up From Bench-Xcale To 2000L STR

Here, experts from Polyplus, Exothera, and Alexion describe how they united to develop a highly scalable AAV manufacturing platform, capable of supporting volumes from 1L to 200L and up to 2000L.

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It's no secret that on-going research aims to improve the efficacy and specificity of non-viral approaches for genetic engineering. But the field is rapidly evolving with research aimed at improving transfection efficiency, targeting, and safety profiles of non-viral delivery systems. Join Cell & Gene Live to discuss the most notable approaches and recent breakthroughs as well as promising non-viral vectors used in clinical trials. Attendance is free thanks to the support of MaxCyte.

MANUFACTURING SOLUTIONS

Eppendorf BioFlo 320 Bioprocess Control Station - Eppendorf SE

Single-Use mAb Process Playbook - Thermo Fisher Scientific Bioproduction

Quick Delivery Program Of Aseptic Filling Systems For Life Sciences - AST

A Disruptive Technology Accelerating Drug Development - Precision NanoSystems

Single‑Use Filtration System For Pilot‑ And Small‑Scale Manufacturing - Cytiva

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