Commonly, when a person hears about Escherichia coli (E. coli), the news is negative. But it’s only a specific strain of E. coli detected on food that wasn’t cleaned or stored properly that’s a health hazard. When it comes to biotech, however, E. coli rocks! It’s been the workhorse for the creation of a multitude of products due to:
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.
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.
When it comes to gene editing technology, there are few meetings as valuable for us and our collaborators as the annual CRISPR meeting. Academic in focus and highly technical in nature, the 2022 edition of this event came to Boston, packing more than 40 lectures and 120 posters into a rapid-fire, three-day learning experience.
Historically speaking, drug master files (DMF) have been used in filing Investigational New Drug applications (IND). However, they’ve never been used for CRISPR because that’s a relatively new therapy. With new draft FDA guidance relating to cell therapies using CRISPR, we’re moving further ahead into a new frontier of genomic medicine.
In my previous post on new draft FDA guidelines that concern cell therapies, I covered key control considerations for CRISPR reagents and the GMP manufacturing considerations for drug substances affected by that guidance. In this post, I’ll go over a couple approaches to consider when working with gene-modified cell therapies, and how they could be affected.
The FDA recently released draft guidance on Investigational New Drug (IND) applications for Human Gene Therapy Drug Products Incorporating Human Genome Editing technology to edit human somatic cells. This much-anticipated draft highlights manufacturing, quality, and regulatory considerations for drug developers preparing IND filings for novel, gene-modified cell therapies.
Nate Spangler, Ph.D., Director of Innovation & Strategy at Aldevron discusses the challenges of manufacturing mRNA under the increased demand and helpful strategies to solve them.
Nate was interviewed by Michael Dunnet for TIDES TV.
Justin Byers, Client Relations Senior Manager, GMP Custom Protein Services at Aldevron discusses important considerations for achieving GMP quality protein manufacturing for advanced therapeutics and vaccines.
He was interviewed by Michael Dunnet for TIDES TV.
