Newsletter | March 28, 2023

03.28.23 -- CGT's Highly Anticipated Regulatory Decisions

 
New Podcast Episode
Featured Editorial
Industry Insights
Critical Factors To Cell And Gene Therapy Forecasting

Innovation in cell and gene therapies (CGTs) is leading to rapid growth in the space and transforming standards of care. Learn about the major considerations for developing CGT forecasts.

5 Tips For Operationalizing Gene Therapy Studies

Discover tips on operationalizing gene therapy studies in order to optimize site selection and patient recruitment and engagement.

The Raw Material Hurdle: Plasmids For Viral Vector-Based Gene Therapies

The success of using viral vectors to deliver a molecular payload into a cell or replace defective genes with functional ones is an inflection point in the future of modern medicine.

Effects Of Annex 1 Revisions On Manufacturing Operations

The revisions to EU Annex 1 set the stage for the future direction of the pharma/biotech industry. Explore some of the key takeaways and interesting changes for risk management and contamination control strategies.

Can CDMOs Provide Leadership In Cell And Gene Therapy?

Learn what industry experts have to say about how CDMOs are adding value through stability and development expertise, developing partnerships with innovators, and implementing the latest technologies.

mRNA Vaccines & Therapeutics Manufacturing Challenges - mRNA Manufacturing

Learn more about the challenges that arise during the synthesis, purification, and encapsulation of mRNA.

Osmolality Monitoring For UF/DF And CEX Capture Of mAbs From Mammalian Cell Cultures

The goal of this study was to understand the impact of monitoring osmolality during an ultrafiltration/diafiltration (UF/DF) step prior to CEX capture of the monoclonal antibody Rituximab.

The 'Champagne' Of Human Umbilical Cord Cells?

Learn about a novel method to obtain unique HUCPVs and how premium-quality hUC-MSCs drive innovative translational research.

Using The 505(B)(2) Pathway To Streamline Approval Of Combination Products

In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.

Introduction To mRNA Manufacturing

The SARS-CoV-2 virus has changed the course of scientific research around messenger RNA (mRNA). Learn about mRNA manufacturing, the structure of a mRNA molecule, RNase-free considerations, and more.

Attribute Monitoring Workflows: Connecting Molecular Attributes To Product And Process Knowledge

For biopharmaceutical organizations that need the power and performance of LC-MS for routine screening and MAM, we have designed the first SmartMS-enabled biopharma LC-MS solution. Learn more about connecting molecular attributes to product and process knowledge using the BioAccord System.

The Wider Use Of mRNA To Treat Various Forms Of Cancer & Autoimmune Diseases

Each of the diseases discussed is going to be different in the way it manifests, and the target cell arguably is going to be different as well. Strapps and Kalayoglu break it down disease by disease.

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