Newsletter | January 7, 2025

01.07.25 -- Navigating The Challenges Of Bringing Cell And Gene Therapies To Market

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With over 450 unique products in clinical development and 50 anticipated approvals by 2030, the evolving regulatory landscape for cell and gene therapies is more critical than ever. Don't miss your chance to gain expert insights! Join the next Cell & Gene Live for an exclusive digital panel discussion exploring forward-looking perspectives on this transformative field. Registration is free—thanks to the support of Thermo Fisher Scientific.

FOCUS ON MANUFACTURING

2025 Outlook For CGT: Focus On Non-Oncology Indications, In Vivo Gene Editing, And POC

Leaders from Kiji Therapeutics, Precision Biosciences, and Orgenesis weigh in on what will likely accelerate the development of novel treatments, potentially revolutionizing patient care across a wider range of diseases and bringing the promise of personalized medicine closer to reality in 2025 and beyond.

Navigating The Challenges Of Bringing Cell And Gene Therapies To Market

Cell and gene therapies are witnessing rapid advancements, but significant challenges remain for their commercialization due to regulatory hurdles, manufacturing barriers, high costs, and safety concerns.

The Starring Role Of Stirred Tank Bioreactors

Stirred-tank bioreactors have emerged in recent years as the optimal platform to optimize (stem) cell culturing raising their potential in the cell and gene therapy industry.

Innovation, Tech, And Collaboration In Advanced Materials

Demands for flexible, scalable, cost effective manufacturing are prompting cell and gene therapy manufacturers and CDMOs to implement single-use technology for manufacturing their therapies.

Enhanced mAb Production With High-Intensity Perfusion CHO Medium

Reach new heights in mAb production with a high-intensity perfusion CHO medium designed to support consistently high product yield and quality in continuous perfusion cultures using CHO-K1 cells.

Bioreactor Scaling Made Simpler

Gain insight into how digital standardized tools can streamline your scaling processes and enable more accurate prediction and visualization of your scaling needs.

Get Full Control Of Your T Cell Isolation

This study demonstrates the automated magnetic isolation of CD4/CD8+ cells from fresh or frozen leukapheresis using a functionally closed cell processing system paired with a modular application.

Distinguish And Quantify Particles In Adenoviral (AdV) vectors Capsids

Explore the application of macro mass photometry in analyzing AdV vectors, distinguishing between empty and full viral capsids, and accurately measuring the proportion of full capsids present.

Guidelines For Comparing SYBR Green Master Mixes

Explore a protocol for comparing the performance of Applied Biosystems PowerTrack SYBR Green Master Mix with other master mixes in PCR applications.

Isolator Air Handling: Advancements For Fill-Finish Processing

When it comes to fill-finish manufacturing of parenteral liquid pharmaceuticals, your choice of barrier technology is crucial.

Natural Killer Cell Expansion And Scale-Up In Vertical-Wheel Bioreactors

Allogeneic Natural Killer (NK) cell therapy offers a promising avenue for cancer immunotherapy. However, traditional platforms struggle to achieve the scalability required for clinical translation and commercial manufacturing.

MANUFACTURING SOLUTIONS

Executive Roundtable: Cell Therapy Predictions For 2025 And Beyond - Cell & Gene

Cleanroom Facility Plan: The Right Direction, From The Start - AES Clean Technology, Inc.

The Korus System - Invetech

Automated Single-Use Bag Filling System For CGT - Single Use Support

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