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.
"Biomanufacturing" and "efficiency" are two terms that are not commonly seen together, but researchers at the University of Wisconsin-Madison Engineering Department along with protein manufacturing experts here at Aldevron are taking big steps to change that.
The application of Quick Response Manufacturing (QRM) theory to biological processes is a unique initiative whose goal of reducing lead times for manufacturing operations is the core focus of the UW and Aldevron partnership.
Groundbreaking technologies arise every decade or so, advancing genomics research and the development of new medicines. Restriction enzymes in the 70s, polymerase chain reaction in the 80s and next-generation sequencing in the 90s all represented huge leaps forward. Recently, however, the CRISPR revolution has shown the potential to overshadow them all.
CRISPR, or clustered regularly interspaced short palindromic repeats, is a long-sought breakthrough for making highly specific changes to genetic codes. Compared to established technologies such as zinc-finger nucleases (ZFNs) and transcription activator like effector nucleases (TALENs), the CRISPR system using Cas9 nuclease is faster, easier, more precise and more flexible.
CRISPR technology will have great impact on basic and applied life-science research. Therefore, important questions should be asked when choosing a partner that can develop and manufacture CRISPR components such as Cas9 to meet your present and future needs for Cas9 product design, scale and quality.
We’ve reviewed three important reasons why experience and expertise matters when choosing such a partner.
