Newsletter | April 5, 2024

04.05.24 -- 8 Key Takeaways Of The Proposed FDA Modernization Act 3.0

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Webinar: Insights and Strategies for GMP Manufacturing of RNA-Lipid Nanoparticles

The emergence of RNA-encapsulated-lipid nanoparticles (LNPs) has introduced a seismic shift in biopharma innovation. But how will the industry adapt to diversifying applications and scales going forward? Join David Sokolowski with Cytiva and Jason Coleman with Precision NanoSystems to learn how to leverage manufacturing workflows, processes, and technologies for mRNA vaccine and therapeutic development.

FEATURED EDITORIAL

8 Key Takeaways Of The Proposed FDA Modernization Act 3.0

This legislation aims to reduce and replace the use of animals in nonclinical research, improve the predictivity of nonclinical testing, and reduce development times. However, it will need to be passed by the House and Senate and signed by the president before becoming law.

The Need For Speed: Meeting Unmet Need For Pediatric Patients

How can sponsor companies accelerate development in pediatric patients for genetic diseases that affect both children and adults, but where gene therapy holds the greatest promise to address unmet needs in pediatric patients?

INDUSTRY INSIGHTS

Improve Your AAV Manufacturing Process

Meet the growing demand for AAV-based gene therapies using design-of-experiment and fit-for-purpose plasmids and transfection reagents.

2024: The Year Of EHR eSource In Clinical Trials

Discover the power of EHR eSource in 2024—unlock 10 compelling reasons to elevate your approach and enhance clinical research outcomes.

How Digital Quality Management Is Transforming Pharma Manufacturing

How can pharma manufacturing adapt to be more agile, data-driven, and prepared for the future? The solution lies in digital transformation.

CRISPR Clinical Trials To Follow In 2024 And Beyond

CRISPR therapies are being developed for genetic disorders, cancer, and infectious diseases. Explore which CRISPR clinical trials are worth keeping an eye on this year.

Empowering Biopharma With Single-Use Cryopreservation Solutions

Examine four common applications of cryopreservation and the science behind selecting the appropriate materials to build single-use solutions that enable cryogenic storage for cell and gene applications.

The Importance Of Scalability In Viral Vectors

Diseases that lack a cure, or even treatment, may be addressed with new gene therapeutic classes. This potential has spurred new investments in the drug development and commercialization space.

Addressing Key TIL Therapy Manufacturing Workflow Challenges

From tumor resection to therapy delivery, there are a number of hurdles at each stage of your TIL therapy manufacturing workflow. Here, we address key challenges at each stage of the workflow.

A Step-By-Step Guide To Cell Banking

Cell banking stands at the forefront of medical advancement. This guide delves into the steps involved in protecting these priceless resources, from cell collection and processing to storage and cell expansion.

Cell And Gene Therapy Facility Design Considerations

Walk through 20 reasons why it's essential to establish a specialized cleanroom environment specifically tailored for your cell and gene therapy products.

Lentiviral Vector Characterization Made Easy

Learn one way to address the challenges presented by SDS-PAGE and ELISA analytical techniques when accurately characterizing viral vectors for various attributes.

SOLUTIONS

MicroCNX Series Connectors Assembly Overview

Single Use Centrifuges For Cell And Gene Therapy: U2k

Accelerate The Development Of LNP Formulations And Drug Products

Life Sciences Manufacturing Excellence

Products For Instrument Standardization And Compensation

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