iPSC GMP Grade
Applied StemCell is in the process of getting GLP and GMP certified and complied with. With our core technologies, CRISPR, TARGATTTM, and iPSC, ASC can produce almost any gene modification including therapeutic gene/reporter gene insertion, point mutation correction, small nucleotide addition, replacement, and deletion. ASC can now offer a wide range of GMP clinical grade iPSC-related services. We can use ASC’s gene-editing technologies to engineer our GMP lines to express your gene of interest (GOI). Our expert scientist can also work with your GMP line and perform gene editing using good manufacturing practices (GMP). If you are interested in developing commercial products, we also offer a TARGATTTM iPSC Master Cell Line for your individual research needs!
GMP Gene-Editing Services
- We can take our GMP line and express your GOI and you obtain GMP/research-grade results
- Using your GMP line, we can perform the gene-editing you would like while following good manufacturing practices (GMP)
Applied Stemcell also offers GMP grade knockin cell line generation using our TARGATT™ Master iPSC Line. Our TARGATTTM technology enables transgene knockin at a safe-harbor locus.
- TARGATT™ Master iPSC Cell Line generated from our well-characterized iPSC lines with proven differentiation capability
- High efficiency, unidirectional integration
- Site-specific, stable knock-in
- Single copy gene integration
- No disruption of internal genes
ASC is working towards developing a comprehensive inventory of GMP clinical-grade iPSC-related products and is currently building a TARGATTTM Universal Modifiable iPSC platform for therapeutic cell production.
ASC's GMP facility is set for iPSC generation, expansion, gene editing, and differentiation as well as general cell banking processes. ASC’s GMP facility includes manufacturing space, the storage for raw and finished products, and support lab areas. ASC’s GMP facility operates under the guidelines established by the CFR (Code of Federal Regulations) Title 21, Parts 1271 (Current Good Manufacturing for Human Cells, Tissues, and Cellular and Tissue-Based Products).