Connecting on CRISPR
Innovation from the CRISPR 2022 Meeting
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.
DMFs for CRISPR
Applying an old concept to CRISPR applications
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.
How New FDA Guidelines Can Affect Cell Therapy Development, part 2
The effect on autologous and allogeneic therapies projects
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.
How New FDA Guidelines Can Affect Cell Therapy Development, Part 1
Defining control considerations for CRISPR reagents is key
The FDA recently released draft guidance on Investigational New Drug (IND) applications for Human Gene Therapy Drug Products Incorporating Human Genome Editing technology to edit human somatic cells.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.
TIDES TV: Tackling mRNA Manufacturing Challenges
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.
TIDES TV: Achieving GMP Quality in Protein Manufacturing
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.
GMP Protein Manufacturing: Aldevron Delivers Excellence
Aldevron has offered off-the-shelf GMP protein products since 2017, but our customers are often surprised to discover that we can also manufacture custom GMP proteins.
Contributing to a Cure for Sickle Cell Disease
Every year, an estimated 300,000 children are born globally with a severe form of sickle cell disease. This is a genetic disease that causes red blood cells to be a sickle shape, leading to episodes of pain and anaemia, along with the potential of stroke or kidney damage.
Genetic Medicine Advancements Help Aldevron Grow Madison Facility
The team at Aldevron is excited to virtually celebrate our recent expansion in Madison and share the great progress we’re making and opportunities ahead in the world of gene therapy.