Newsletter | August 4, 2022

08.04.22 -- Epigenetics: A Precision Approach

 
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Industry Insights
In-House Plasmid Production To Secure Supply Chains

A CDMO with in-house plasmid manufacturing capabilities can help companies accelerate timelines and ensure material availability, ultimately saving time and money throughout their product life cycle.

Four Obstacles In Cell And Gene Therapy Development

Explore some of the major challenges in the cell and gene therapy world and how single-cell multi-omics analysis can overcome many of these issues.

Advanced Therapy Manufacturers' Checklist For Cleanroom Project Success

Current advances in cell, gene, and tissue therapies require a rethinking of how—and where—cleanroom manufacturing facilities could be built enabling more options for sponsor process control.

Process Characterization And Validation For Biologic Processes

Using a risk-based approach to generate an appropriate control strategy will help assure your product meets characterization and validation requirements, enabling timely approval and launch to market.

Efficiency Of A Transfection Reagent In Hard-To-Transfect Stem Cells

Discover how our transfection reagent demonstrates robust, non-toxic, and efficient gene expression delivery in hard-to-transfect primary hMSCs, mESCs, and induced pluripotent stem cells.

AAV Application Notebook

Learn how AAV characterization and stability screening are achieved with multi-angle light scattering coupled to separation methods and high-throughput dynamic light scattering.

The Importance Of Scalability In Viral Vectors

With gene therapy, diseases that lacked cures or even treatments may be addressed with these new classes of therapeutics. This potential has spurred new investments in the drug development and commercialization space.

Single-Vendor CDMOs Bring Speed And Cost Savings To The Table

As drug developers face the ever-pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help.

Unlocking The Full Potential Of Genomic Medicine

There are two key challenges to realizing the potential of genomic medicines, but potential technological solutions are on the horizon, and we examine each.

3 Issues With The Supply Chain In Cell And Gene Therapy

Learn about some of the current issues impacting the manufacture and supply of cell and gene therapy products, including manufacturing and shipping costs, upscaling, and pandemic-related issues.

Biopharma Supply Chain & Infrastructural Needs In The U.S.

Review four essential areas where biomanufacturing process infrastructure is lacking and the infrastructure needed to enable scalable, cost-effective, rapidly deployable, and adaptive biomanufacturing for the future.

Cell Therapy Scale-Up Strategies For Commercial Success

This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development.

Filling Industry Gaps With Dedicated Cell & Gene Therapy Fluid Transfer Sets

Read how the incorporation of transfer sets designed to support CGTs will aid in the implementation of controllable, consistent, and safe cGMP amenable manufacturing procedures.

Human Regulatory T Cell Expansion And Measurement Of Function

Regulatory T cells (Tregs) are a subpopulation of T cells with the unique ability to suppress the activation of effector T cells and thereby prevent T cell function. This application note describes an optimized protocol for activation and expansion of flow-sorted Tregs with Gibco CTS Dynabeads Treg Xpander.

When Every Sample Is A Life Trusted To Our Care: How CRL Automated Assay And Scale Throughput

Discover how our technology played a critical role in CRL’s exceptionally fast development and scale-up of a saliva-based SARS-CoV-2 assay to meet the unprecedented testing need.

Technology Integrators In Cell And Gene Therapy: Powering Innovation

Accelerated clinical trial timelines for advanced therapeutics are on the rise. With fast-track status designations, it is increasingly critical for innovators to have efficient and scalable production processes.

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