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GMP & RUO Grade iPSC Gene Editing & Differentiation Services

GMP & RUO Grade iPSC Gene Editing & Differentiation Services

Use Applied StemCell's (ASC) new GMP facility, comprised of five cleanrooms equipped with cutting-edge technology, to develop the next generation of iPSC-derived therapeutics. We have dedicated cleanrooms for induced pluripotent stem cells (iPSC), mesenchymal stromal cells (MSC), chimeric antigen receptor T-cells (CAR-T), T-cell receptor-engineered T-cells (TCR-T), natural killer (NK) cells, CAR-NK cells, and viral vectors. Explore our end-to-end manufacturing service options or optimize your GMP SOP with our GMP master cell bank or high-quality starter options.

GMP & ROU iPSC Gene Editing

Engineer mainstream point mutation and knockout cell lines or safely and efficiently generate large complex knock-in cells for further differentiation and assay development.

Advantages of ASC’s Gene Editing Technology

• TARGATT site-specific knock-in of any gene of interest up to 20kb (iPSC-GMP-TARGATT)

• SSelect for large cargo insertion with double-digit efficiency

• ceBE-X for base editing for knockout and point mutation with zero off-target events

• Optimized CRISPR/Cas9 protocols for high-throughput editing

• GMP and Research Use Only services

Pluripotency is maintained throughout the gene editing process, and medium to high expression levels have been observed.

GMP & ROU iPSC Differentiation

Differentiate normal or genetically modified iPSCs into natural killer (NK) cells, cardiomyocytes, photoreceptor cells, neural progenitor cells (NPCs), astrocytes, and many more cell types. Receive

robust, lineage-committed cells identified by lineage-specific markers that have undergone standard characterization.

Comprehensive Differentiation Service

• Differentiation from healthy or disease iPSC lines: customer cell lines, ASC’s control iPSC lines, or genetically engineered iPSCs

o Off-the-shelf iPSCs: (1) GMP iPSCs (2) GMP Matching iPSCs (For Research Use Only) (3) Knock-in ready TARGATT-iPSCs (Also available for CIRM awardees)

• High-purity cell lines

• Non-integration differentiation protocols

• Co-culture model development

• Cell expansion and banking (24/7 monitoring)

• GMP and Research Use Only Services

The differentiated high-purity cells express high levels of their specific cell markers: (1) NK cells (≥ 80% purity) express CD56 and CD45, (2) cardiomyocytes (≥80% purity) express cTnT, (3) photoreceptor cells (≥90% purity) cells express CRX and NR2E3, (4) NPCs (≥95% purity) express Nestin, and (5) astrocytes (≥95% purity) express GFAP and s100beta.

Product Specifications
iPSC Generation Service Timeline 2-3 months
CRISPR Gene Editing Service Timeline (1) Knockout, 6-8 weeks (2) Point mutation, 6-8 weeks (3) Knockin, 10-15 weeks
TARGATT Gene Editing Service Timeline 3-5 months
NK Cell Differentiation 2 months
Cardiomyocyte Differentiation 2 weeks
Photoreceptor Differentiation 3 months
NPC Differentiation 3 weeks
Astrocyte Differentiation 2 months
MSC Banking ~ 2 .5 weeks
MSC Expansion ~2 weeks
About Applied StemCell
As a leading cell and gene therapy contract research organization (CRO)/contract development and manufacturing organization (CDMO), Applied StemCell is a proud supporter of gene editing and stem cell therapy development. With two high-impact platforms, CRISPR/TARGATT<sup>™</sup> genome editing and induced pluripotent stem cell (iPSC) (good manufacturing practice (GMP) grade), they seek to help advance the development of novel therapeutics. Along with their wide range of CRO service options, Applied StemCell provides GMP gene-editing and cell manufacturing services along with cell banking.
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