The Drivers for Change in hiPSC Single Cell Cloning for Master Cell Banks
hiPSC cells are a source of potential cellular immunotherapies including TCR-T cells, CAR-T and NK/NKT cells. In the commercial setting, hiPSC Master Cell Banks must be produced under cGMP conditions and utilize the practice of single cell cloning.
Current workflows are time consuming (60-90 days) and present challenges to auditing and quality control. Post gene editing and nucleofection, a common workflow would utilize dilution cloning into 10cm Petri dishes followed by picking and multiple expansion steps.
The Solentim 30 Day Workflow, Fit for IND Submission
Our Solentim portfolio of assurance rich technologies will help you accelerate your workflow. VIPS® enables high seeding and outgrowth efficiencies and a ‘double lock’ of assurance. Cell Metric® captures and records whole well images at day 0 with daily imaging thereafter, delivering the Clonality Report, which serves as evidence for a successful IND submission.
To further enhance your workflow and support iPCS growth, incorporate MatriClone™ in the VIPS seeding protocol. MatriClone, an animal component-free matrix, offers high levels of single cell survival and subsequent outgrowth, which avoids the need for coating plates.
Optimize Your Cell Line Development
When the therapeutic you’re developing is cell-based, constant monitoring to optimize growth and ensure consistent culture conditions throughout multiple stages is critical for success.
Adding a simple osmolality measurement to the in-process parameters you measure is a quick and easy way to ensure optimal cell growth, during process development and manufacturing as well as during feed and media preparation.
Optimize Your Cell Therapy Workflow While Maximizing Yields and Providing High Quality Therapies to Your Patients
Ensure stem cells are at the highest viability and product quality levels throughout the entire cell therapy workflow from culture and processing all the way to fill and finish.
While we are currently validating other applications, which would broaden its reach, I’d absolutely recommend the VIPS now for any labs looking for true clonal studies or cell line development using hiPSCs. With both the seeding robustness and data reporting, this system simplifies the process and strengthens the quality of the biology for cell therapy development.
Philip D. Manos, Founder and President of EverCell Bio, Natick, Massachusetts, USA
Understanding the Impact of Osmolality on Upstream AAV Manufacturing
Osmolality, a measure of solute concentration, is a critical attribute in the bioprocess workflow, whether one is manufacturing therapeutic antibodies or in the production of viral vectors for use in Cell & Gene Therapy applications. Understanding the osmolality of solutions used in each step provides critical information on culture conditions, material quality at each step of purification, and final formulation composition.
Popular Educational Resources
Learn more about how our technologies can be utilized to help accelerate your cell therapy workflow by checking out our educational resources below
Application Note
Development of a highly efficient, documented workflow for making clonal cell banks of gene-edited iPSCs
Webinar
Osmolality, a Critical Quality Attribute for Cell Line Development and Cell Therapy
Associated Products
OsmoTECH® HT Automated Micro-Osmometer
Automated high-throughput plate-based osmometer for cell line and process development
OsmoTECH® PRO Multi-Sample Micro-Osmometer
Combines ease-of-use with accurate and precise measurements for reliable results
Solentim VIPS® PRO
High efficiency, single cell seeding with image-based proof of clonality for GMP-compatible workflows
Bioprocessing Services
Get the best performance from your osmometers and cell line development instruments from the people who designed and built them. We provide a range of services and service plans to meet the different needs of our customers.
Our certified Field Service Engineers provide on-site professional support for the installation, training, validation, and maintenance of your Advanced Instruments products.
