iPSC Manufacturing Services For Cell Therapy

Are you looking for an experienced, flexible GMP service provider that can help you with the development of your gene or cell therapy? As a gene and cell therapy CDMO, Applied StemCell offers a complete GMP cell manufacturing service platform for the development of allogeneic products. We provide custom service options such as cell blanking and cell product manufacturing (e.g., iPSC gene editing, differentiation, and generation). At ASC, we can produce GMP-grade cells for pre-clinical and commercial purposes, and we have the capacity to support commercial manufacturing with our safe and efficient scale-up processes.

iPSC manufacturing is complex. You can encounter several challenges in the process of generating your cell/gene therapy, but you are not alone. ASC’s GMP manufacturing experts can work with you every step of the way. We can assist in the development of your project outline, and we guarantee detailed updates as we carry out your project until it is complete and your final product is delivered.

Would you like to get started? Contact us today to schedule your free consultation.

GMP Service Options

Why Applied StemCell?

• Comprehensive GMP Manufacturing Service Platform 
  • iPSC generation, gene editing, differentiation
  • GMP-grade. off-the-shelf iPSC Line and GMP-compliant TARGATT^TM iPS Cell Line
• Working Cell Bank and Master Cell Bank Service
• Scale-up Services
• ASC complies with cell processing GMP facility regulations
• Quality control protocols based on ICH-Q5A/D guidelines 
• ISO Class 5 and 7 (Class 10,000 and 100) clean room

GMP iPS Cell Expansion and Banking >>

GMP iPSC Genome Editing and Expansion

We offer two gene editing technologies for genome editing, TARGATT^TM and CRiSPR.

• CRISPR/Cas9 Gene Editing
  • Customer needs to obtain CRISPR license
  • ASC performs fee-for-service gene editing
• TARGATT™ Gene Editing
  • License terms are already in place
•  In-Process QC: Reagent QC (plasmid map/sequence), Validation (cell, gRNA, integrase), Transfection pool genotyping, and Clone genotyping

ASC also offers GMP-like plasmid production for gene editing (QC: purity, sequence, residual host DNA/protein/RNA test, etc)

GMP iPS Differentiation 

At ASC, we have completed many iPSC differentiation projects, and we have the expertise to further differentiate your control or genetically modified iPSCs to committed somatic lineages (e.g., neural progenitor cells, dopaminergic cells, astrocytes RPEs, photoreceptor cells, natural killer cells, and more).

• iPSC differentiation with a customer provides protocol
  
  • Service includes: tech transfer, engineering run and scale-up
• iPSC differentiation with ASC SOPs
  • engineering run and scale-up
  • cGMP production 

GMP iPSC Generation and Expansion From Customer-Requested Tissue Sample Type

With over 13 years of stem cell and gene editing expertise, we can generate iPSCs from various human tissue types using an episomal reprogramming method.

• Seed Bank:
  • 3 clones
  • 10 vials
  • 1x10^6 cells/vial
  • QC Characterization and CoA