Newsletter | January 9, 2024

01.09.24 -- A Brief Guide For Vaccine Companies Working Toward FDA Approval For The First Time

FEATURED EDITORIAL

A Brief Guide For Vaccine Companies Working Toward FDA Approval For The First Time

By Padmini Ayapilla, Freyr Solutions

This article outlines best practices for expediting the FDA approval process while maintaining safety and efficacy standards. Tips are related to vaccine R&D, understanding the Emergency Use Authorization (EUA), post-approval surveillance and monitoring, and more.

INDUSTRY INSIGHTS

SimpliFiH Solutions For Accelerated Pharmaceutical Development

Article | By David K. Lyon, Ph.D., and Conrad Roten, Ph.D., Lonza

Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.

Continuous Flow Techniques For Fine Chemical Manufacturing

Webinar | Lonza

Explore the advantages and challenges of continuous flow processes and the concept of mini-monoplant technology, along with examples that demonstrate the versatility of continuous processing.

mRNA-Lipid Nanoparticles Circumvent Viral Vector Limitations

Article | Precision NanoSystems

Both physical and chemical nonviral gene delivery systems for ex vivo genetic modification offer advantages over viral vectors, including smaller-scale production and the low risk of immunogenicity.

Following The Science To Develop Best-In-Class Cancer Drugs

Article | Cytiva

As innovative cancer therapeutics continue to enter the clinical trial pipeline, some developers are shifting their focus toward developing drugs that are safe and efficacious with minimal toxicity.