Newsletter | January 15, 2024

01.15.24 -- Tackling 3 Challenges In Developing An Inhaled Gene Therapy

SPONSOR

Cell & Gene Live welcomes Dr. Peter Marks, director, CBER, FDA, and Dr. Nicole Verdun, super office director, CBER, FDA, to discuss the evolving regulatory landscape in 2024 for cell and gene therapies. Join this interactive discussion as we cover improved communication with sponsors, increased speed availability through manufacturing processes and standards development, and much more. Registration is free thanks to the support of Thermo Fisher Scientific.

FEATURED EDITORIAL

Tackling 3 Challenges In Developing An Inhaled Gene Therapy

Inhalers hold great potential for delivery of high concentrations of gene therapy directly into the lung. Review this team's experiences regarding the development of a gene therapy to treat cystic fibrosis.

INDUSTRY INSIGHTS

In Focus: The 'C' Of CDMO

Delve into the intricacies of a successful CDMO relationship and learn how a collaborative approach built on shared goals and open communication can maximize the potential of your cell therapy program.

Development Of A Downstream Processing Platform For AAV

There is a growing need for innovative solutions that reduce costs while maintaining high product quality. This poster presents investigations to derive an economic and scalable method for purification of AAV.

Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs

Consider the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.

A Collaborative Approach To Viral Vector Development And Manufacturing

Explore how partnering with a CDMO experienced in viral vector production can reduce costs, mitigate risk, and shorten development timelines, helping to deliver lifesaving products to patients in need.

Qualification Considerations For A 'Factory-In-A-Box'

The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive. Enter the "factory-in-a-box," which can be a game-changer.

How Our Requalification Process Maintains Material Integrity

Review a breakdown of how to requalify every shipper for its impending transit and ensure your therapy material maintains integrity and safety during transportation.

SOLUTIONS

The Center For Cell And Vector Production (CCVP)

Global Regulatory Strategy: 23 Questions With Claire Marasco

Allogeneic And Autologous Cell Therapy CDMO Services

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