Newsletter | December 4, 2024

12.04.24 -- How Platform Technologies Are Shaping The Gene Therapy Landscape

FEATURED EDITORIAL

How Platform Technologies Are Shaping The Gene Therapy Landscape

Leading experts in gene therapy discuss CMC strategy for platform technologies, product lifecycle management, and the role CDMOs play in moving the space forward.

Tackling The Standardization Issue For mRNA Therapeutics

This segment features a discussion around the obstacles to establishing a standardized production pipeline for mRNA therapeutics across the industry as well as some the approaches being considered to standardize cold chain management protocols for mRNA products.

A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies

This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities. 

INDUSTRY INSIGHTS

Optimizing mRNA For Success

RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.

End-To-End Solutions To Support Your mRNA Therapeutics Workflow

Take a step-by-step review of the mRNA therapeutics journey and find out how you can meet the critical process, scale, quality and regulatory needs from development to commercialization.

How mRNA Manufacturers Disrupt The Industry

Learn how biopharmaceutical companies can apply proven strategies to overcome hidden complexities in mRNA production, and discover solutions that can help you rapidly design and build a SU facility.

Addressing The Challenge Of Poor Aqueous Solubility

As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.

Unlocking The Potential Of mRNA Vaccines

This webinar highlights the potential of mRNA therapies and focuses on the manufacturing process associated challenges, solutions and perspectives from synthesis to delivery.

Methods For mRNA Poly(A) Sizing

This study used Oxford Nanopore Technologies' Direct RNA Sequencing Kit and obtained successful sizing of poly(A) tail regions. The results are presented in a histogram and table format.

Reducing Risk In mRNA Therapeutic Development

Advancements in purification, delivery mechanisms, and stability during storage and transport will enable the future of mRNA-based therapies.

Five Essentials For Accurate Oligonucleotide Chemistry

Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.