cGMP Cell Manufacturing

Complete GMP iPSC & MSC Platform

Are you in need of an experienced and flexible GMP service provider that can assist you with the development and clinical manufacturing of your gene or cell therapy with expert CMC support?

Gene and cell therapies are paradigm changing, new therapeutic genomic medicine. This makes the CMC and regulatory landscape quite complex to navigate successfully compared to small or large molecule-based therapies. Especially in cell manufacturing, you may encounter various challenges, but you don’t have to face them alone. ASC’s GMP experts can guide you through every step of the process from technology transfer, engineering run, analytical method qualification, scale-up, and GMP production. We can help you develop your project outline and ensure you receive detailed updates as we collaborate on your project until it is completed.

At our cGMP-compliant facility, we offer custom cell therapy manufacturing service options, including:

Cell product development: iPSC genome editing and differentiation
iPSCs and differentiated cell lines: customer provided or ASC’s GMP-grade iPSC Master Cell Lines
Gene editing: a wide range of genetic modifications leveraging a variety of gene editing technologies such as our proprietary TARGATT™™™, MAD7 and Accubase; also includes GMP Plasmid DNA Production scaled for gene editing use
Scale-up and Cell banking: Seed cell banking, working cell bank and master cell bank services
Fill/Finish: Formulate, fill, and finish per your specifications
In-process and release testing: Wide range of QC capabilities available for GMP and characterization testing

Our team can help you overcome CMC challenges and has the experience to advise on operational, logistic, quality and regulatory considerations for successful IND / CTA submissions and clinical supply. Our cGMP facilities are compliant for:

FDA compliant cleanrooms per ISO standards (ISO 7 rooms with ISO 5 workspaces) with readily available space to expand
Continuous electronic monitoring and trending of key equipment and facilities
Dedicated GMP areas with electronic access control
Validated eQMS ensuring data integrity and traceability
Clinical drug substance and drug product manufacturing

Comprehensive iPSC-derived Cell Product Manufacturing

Our one-stop cGMP-compliant, iPSC Cell Product platform spans the whole range of iPSC related activities from iPSC generation, gene editing, differentiation and further to cryopreservation and cell banking.

GMP-grade, TARGATT™™TM iPSC Master Cell Lines: With landing-pad ready to knock-in your gene of interest and differentiate to isogenic, allogeneic iPSC-derived cell products
cGMP iPSC Line Generation: We can reprogram healthy donor or patient-sourced somatic cells to iPSCs using footprint-free episomal or sendai virus method under GMP conditions; we can use our high-efficiency protocols or a reprogramming method of your choice to generate novel iPSC lines.
GMP-compliant iPSC Gene Editing: with a plethora of gene editing technologies such as TARGATT™™™, MAD7, and Accubase, we leverage our established gene editing foundation in iPSCs to engineer mainstream to complex genetic modifications in iPSCs under GMP conditions to advance your cell and gene therapy pipeline
GMP-grade, off-the-shelf iPSC Master Lines: Choose for our GMP-grade master cell lines with proven gene editing and differentiation capabilities as a starting material for your product or as controls for your assay and analytical method development

MSC Cell Product Manufacturing

Mesenchymal stem cells are a popular choice for cell therapy starting material due to their potential to differentiate into multiple lineages. At ASC, we offer end-to-end stem cell solutions, including cell isolation, expansion and banking, characterization, and differentiation.

MSC isolation from different sources: From umbilical cord blood and stroma, adipose tissue, placenta, bone marrow & dental tissues in GMP clean rooms
MSC master cell banks and working cell banks: Fast turnaround times; includes 2D and 3D scale-up manufacturing
MSC gene editing: lentiviral mediated gene editing expertise
MSC drug product manufacturing: Technology transfer, method validation, cGMP controls and documentation for clinical IND filing
iPSC differentiated MSC product manufacturing: Custom differentiation of iPSC to MSC and further to osteogenic and chondrogenic lineages

Primary Cell Product Manufacturing

ASC also offers primary cell isolation, cell banking and cell product manufacturing, featuring primary T cells, NK cells, monocytes, hematopoietic stem cells, etc.