Newsletter | August 13, 2024

08.13.24 -- Identifying Drug Development Opportunities For DMD With CureDuchenne

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Streamlining Testing for Optimized mAb Production

Enhance the efficiency of your monoclonal antibody production workflow with end-to-end testing that meets or exceeds regulatory guidelines. This infographic delves into the intricacies of mAb production, emphasizing the importance of accurate and precise testing at various production stages to help ensure product safety, quality, potency, and regulatory compliance. Explore the potential solutions and their benefits, including analysis software, to help de-risk and streamline your production workflow.

FEATURED EDITORIAL

Identifying Drug Development Opportunities For DMD With CureDuchenne

Debra Miller, CEO and Founder, and Dr. Michael Kelly, Chief Scientific Officer at CureDuchenne talk to Host Erin Harris about the FDA approval for the expansion to the label indication for ELEVIDYS from Sarepta Therapeutics as well as how CureDuchenne works with various biotechs developing gene therapies for Duchenne muscular dystrophy (DMD).

 

INDUSTRY INSIGHTS

 

Clinical Development Of CRISPR-Based Therapies In Oncology

CRISPR-based gene editing techniques provide a way to edit the human genome. Examine the operational implications associated with the evolving therapeutic area of this gene editing tech.

 

Using Next Generation Sequencing Methods For Virus Vector Identity Testing

Sequencing techniques play a crucial role in establishing the quality attributes of a variety of therapeutic products. Learn what advantages NGS offers for obtaining accurate sequences.

 

Q&A Interview: Navigating The Launch Of ATMPs In Europe

Dive into this overview of the evolving regulatory landscape and better understand the importance of proactive planning, collaboration, and expert guidance in navigating the ATMPs ecosystem in Europe.

 

The Past, Present, And Future Of Treating Hematological Cancers

What was once science fiction has moved up to second-line therapy. Read this author's take on navigating the trajectory of how CAR T-Cell Therapy will be used for diffuse large B-cell lymphoma.

 

Non-Small Cell Lung Cancer — Global Clinical Trial Landscape (2024)

Explore cutting-edge NSCLC research with Novotech CRO's in-depth disease analysis, providing insights into innovative therapies, clinical trials, and future directions shaping NSCLC care globally.

 

Resolve Spectral Mixing With Customizable Cell Mimics

Review the details of the standard flow cytometry work flow and which controls are the best fit for your projects that will contribute to a confident data analysis.

 

AAV Purification Using AEX And Mixed-Mode Chromatography

Recombinant adeno‐associated viruses (rAAV) are among the most promising vectors for long‐term gene transduction. In this study we explore chromatography workflow solutions to purify rAAV8.

 

Standardization And Flexibility In Aseptic Filling

Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose?

 

Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing

Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.

 

Better Media, Better Outcomes

As the cell therapy industry experiences rapid growth, media and reagents present a valuable opportunity to meet future therapeutic needs.

 

Are You Leveraging All Of Your Clinical Data?

To develop and execute a successful clinical strategy, trial sponsors must be able to rapidly acquire detailed data insights. See how you can better utilize your trial data and achieve greater insights.

 

Exploring Electroporation: Immunotherapy

This collection of articles discusses the development of cancer immunotherapies through cutting-edge genome engineering and sophisticated strategies.

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Don't miss the next Cell & Gene Live discussion on how CAR-T manufacturing has advanced recently and where it's going. Host Tyler Menichiello welcomes CTMC's Jason Bock, Ph.D., Cartesian Therapeutics' Emily English, Ph.D., and former FDA-turned Dark Horse consultant and CMC Expert, Tal Salz, Ph.D., for this digital event happening Tuesday, August 27, at 11 AM ET. Registration is free thanks to the support of CPC.

SOLUTIONS

Rapidly Create Closed System Assemblies For A Customized Configuration

Culture Module That Sustains The Life Of Cells

A Cell Line Portfolio For AAV Manufacturing

Biotherapeutic Commercialization From Development Through Production

A Plug-And-Play, Ready-In-Minutes, In-Line Multiparameter PAT Platform

Modular Cleanroom Overview

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Webinar: Improve Bioprocess Freezing Outcomes with Analytics and Testing Services

Join us on August 26th to learn how reducing early phase inefficiencies can lower initial investments, significantly lower operations costs, and increase productivity. We will share case studies focused on benchmark testing, using surrogate materials, controlled rate freezing, and at line analytics, to identify potential impacts critical to quality, faster and without extensive analytic burden. Click here to learn more.

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