Newsletter | October 29, 2024

10.29.24 -- A "Particular" Problem For Cell Therapy Products, Part 2: Cell Clumps And Other Inherent Particles

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Webinar: Revolutionizing Cell Therapy Manufacturing With AI: Precision, Efficiency, And Beyond

The webinar will explore how AI is transforming cell therapy manufacturing by optimizing processes, enabling real-time monitoring, and enhancing quality control. It will cover AI applications in process development, improving efficiency, and personalizing treatments. Participants will learn how to leverage AI for better manufacturing insights and accelerated timelines, ultimately leading to more effective patient therapies. Click here to learn more.

FOCUS ON MANUFACTURING

A "Particular" Problem, Part 2: Cell Clumps And Other Inherent Particles

Cell clumps may be present prior to administration of your final drug product. In the absence of regulatory guidance, we recommend establishing a risk management strategy for control of particulates.

Gene-Editing Tips To Enhance Precision In iPSC Allogeneic Cell Therapy

Learn how researchers are leveraging CRISPR nucleases, employing single-cell cloning techniques, optimizing delivery methods, and refining guide RNA design to enhance the safety and efficacy of iPSCs.

Exploring Osmolality As A CQA Within RNA Therapeutics

Discover how osmolality can be applied throughout the bioprocessing workflow for RNA, and recognize the importance of this sensitive measurement, from formulation to cryopreservation.

Understanding Injectable Drug Container Closure Systems

Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

Engineering An AAV Platform For Superior Titer And Capsid Integrity

Insights from real-world case studies show how to optimize AAV manufacturing with a transfection reagent and enhancer platform that boosts titers and percent full capsids by 2- to 10-fold.

Non-Viral Gene Modification For Ex-vivo Cell Therapy

Understand the advantages of non-viral transfection technologies for CRISPR- or transposon-based genetic modification CGT and how an improved electroporation technology can support this approach.

How To Achieve Right-First-Time Manufacturing

Adopt cloud-based Vault LIMS to streamline QC operations, enhance data accessibility, and align with broader IT and business strategies.

Accelerate Process Development With HTS Chromatography Tools

High Throughput Screening (HTS) chromatography tools accelerate process development and reduce material use but are less common in some modalities due to sample limits and required expertise.

Add mRNA Capacity — Flexibly

Explore a platform that addresses five critical pain points to help mRNA manufacturers flexibly scale while improving the digital maturity of their sites.

NEW PODCAST EPISODE

Live from ARM's Meeting On The Mesa With Kiji Therapeutics' Dr. Miguel Forte

This episode of Cell & Gene: The Podcast was recorded on site during ARM's 2024 Meeting on the Mesa in Phoenix. Tune in to hear Host Erin Harris talk to Miguel Forte, M.D., Ph.D., CEO of Kiji Therapeutics, President of ISCT, and Executive Committee Member of ARM about Kiji's clinical plan and why iPSC-MSC therapy for inflammatory diseases shows great promise. Listen now and subscribe so you never miss an episode!

MANUFACTURING SOLUTIONS

Robocolumn® And MiniChrom Chromatography Columns - MilliporeSigma

Cell And Gene Therapy Services - SK pharmteco

Cellular Function With Underlying Molecular Mechanisms - Bruker Cellular Analysis

Manufacturing Execution Systems (MES) For Drug Manufacturing - MasterControl, Inc.

Welders And Sealers That Deliver Dependable, Sterile Results - Terumo BCT

A Single-Use Chromatography System For Small Volumes - Cytiva

Comprehensive Media Solutions For Cell And Gene Therapies - Sartorius

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