Webinar: Comprehensive GMP Manufacturing of mRNA-LNP Drug Products

August 9, 2023

Streamlining the mRNA manufacturing process from Sequence-to-Vial

The manufacture and release of mRNA therapeutics and vaccines is a complex and challenging process requiring a high degree of expertise, capabilities, and experience. The development and manufacturing of final drug product involves several stages that include production of cell banks, linear DNA, and mRNA drug substance, with lipid nanoparticle (LNP) formulation/encapsulation and analytical testing at all steps, through aseptic fill/finish.

Webinar: Aldevron/Repligen Case Study

July 26, 2023

/ by Aldevron

Validation of mRNA concentration determination using variable pathlength spectroscopy

Analytical testing is a critical factor in the development of mRNA-based therapeutics, while at the same time presenting significant challenges. Pre-clinical and clinical testing are only part of what needs to be included in the development process, with the need to meet regulatory requirements while competing in the marketplace being additional considerations.

Evaluating Capabilities

July 19, 2023

/ by Todd Howren, Ph.D.

Dealing with a maturing industry

In my previous post regarding the differences between capacity and capability, I discussed the point that reasonably successful CDMOs have the capacity to manufacture biomolecules in a reproduceable manner and deliver according to a timeline. However, sometimes clients tend to focus on a near-term timeline when evaluating potential CDMO partners, relegating matters that dictate long-term clinical success to future consideration.

Perspectives: Hold on Tight for the Ride

May 31, 2023

/ by Jeff Briganti

A crazy, mixed-up world of cell & gene therapy in 2023

News concerning cell and gene therapy (CGT) may make you feel like you are on a rollercoaster. The ride moves very quickly with a lot of ups and downs, plus a few unexpected turns. As we move through 2023, excitement for CGT remains high, but there are lingering concerns about manufacturing and the ability of health care systems to keep up with the science.

An evolution at TIDES

May 24, 2023

/ by Elisabeth Sequeira

mRNA joins the mix

In the past, the TIDES USA conference event has been focused on oligonucleotide and peptide therapeutics, providing information on development trends and technologies for those industry segments. That is changing now, with an additional focus on mRNA therapeutics coming into the mix.

When Demand Gets Tough, Expansion Gets Going

May 17, 2023

/ by Basam Barkho, Ph.D.

Ongoing growth in CGT capacity

As the era of genomic medicine gains speed with the innovation of new technologies, we are at the forefront of genetic tools that can prevent, treat, or cure human diseases. It’s an exciting time, as during this early stage in developing new biological drug products, academics and industry are working closely to optimize cell and gene therapies (CGT) for a range of diseases.

Advancing through Disruption

May 10, 2023

/ by Bev Cameron, Ph.D.

Achieving advancement in ATMP regulation through disruptive innovation of European healthcare systems

Partnerships and transformation are a large part of our evolving biotech landscape. Not surprisingly, they were two common themes at this year’s Meeting on the Med in Barcelona. As an example, attendees discussed how the lack of harmonization across EU member states has led to fragmented access to advanced therapy medicinal products (ATMPs), which varies from country to country. Chris Fox, president of Novartis Gene Therapies, used her company’s product, ZOLGENSMA®, as an example. It’s approved for use in 48 countries but is only accessible in 35.

Protein Expression for Vaccine Development

April 26, 2023

/ by Justin Byers

Overcoming challenges in process design

Recombinant proteins are an essential component of many vaccines. However, producing these crucial proteins can be challenging. From selecting the appropriate expression system to optimizing fermentation and purification processes, there are many factors to consider when designing a process to make high-quality proteins that can be used for vaccine development.

Aldevron Breakthrough Blog: Thought Leadership