Scale up Culture of iPSC

As a pioneer and undisputed global leader in the field of iPSC technology, Creative Biolabs offers high-efficient iPSC production service for our customers. In addition, now we have built the scale-up culture system for the mass preparation of iPSCs in high quality.

Introduction to iPSCs Scale up Culture

The Necessary for iPSCs Scale up Culture

With the potentially unlimited production of various human cell types in vitro, human induced pluripotent stem cells (hiPSCs) presents great promise in different aspects, such as drug discovery, disease modeling, drug safety assay, and cell-based therapy. At present, the generation of functional human iPSCs is mainly in laboratory research scale which is unable to satisfy meet the envisioned routine applications. For example, approximately 1-10 × 10⁹ functional cells are required for replacing the disease-induced- misfunctioned tissues and organs, and 2.5 × 10¹² red blood cells are demanded in transfusion medicine for each patient. In addition, adequate induced-differentiated cells are demanded to comply with the hiPSCs-related regulatory framework. Above all, a robust and scalable method is required for the generation of large numbers of mature and differentiated iPSCs.

Culture Platforms and Process Scale-up

Two-dimensional (2D) culture originates from human iPSCs grown on the matrix-covered surface of flasks or plates. The matrices can be mitotically inactivated fibroblasts, recombinant proteins, and synthetic polymers. Even with the simple process, the introduction of undesired gradients out of the static culture conditions, including media components, paracrine factors, metabolic waste products and gases, limits its further applications. Based on suspension culture condition, the three-dimensional (3D) culture is a potent approach to support human iPSCs viability and proliferation at the pluripotent state. Moreover, the use of bioreactor systems largely improves the development of dynamic suspension culture.

Bioreactor Systems

In order to overcome the environmental inhomogeneity, two typical bioreactor systems, rotating cell culture device and stirred cell culture tank, have been established for the dynamic suspension culture. The rotating cell culture device is a cylindrical culture vessel that maintains continuous rotation along its longitudinal axis and horizontal axis. Depends on the rotational speed, the immersed cells can be dynamically suspended in quasi-periodic circular motion. Although low shear stresses on cells, the volume capability and the complexity of the technical solutions limit the wide applications of large-scale human iPSCs. Consists of a glass or plastic vessel with an internal impeller, stirred cell culture tank enables keeping cells in suspension. The culture environment, including pH, temperature, and Do, can be detected by integrated probes.

Advantages of Bioreactor Systems

• Promote the control of human iPSCs aggregation.
• Avoid the formation of gradients
• Improve the mass transfer and lead to a high cell density.

With the requirement of large numbers of human iPSCs in clinical applications, Creative Biolabs now can provide various approaches for the scale-up culture of iPSCs. We can also provide various other services regarding iPSC technology, contact us if you are interested in them.

Services at Creative Biolabs

As a biotechnology company, our scale-up culture services are focused on providing high-quality, large-scale iPSC production to support research purposes. This process involves maintaining and expanding iPSCs under strict, controlled conditions to ensure their pluripotency and viability. Here are some key aspects of our process:

• Source Material: Depending on client needs, iPSCs can initially be sourced from an established cell bank or derived directly from donor samples using either integration-free or retroviral iPSC reprogramming methods. We provide reprogramming services that convert adult somatic cells into iPSCs.
• Good Manufacturing Practice (GMP) Facilities: Our GMP-grade facilities provide strict control over environmental factors such as temperature, humidity, and sterility, which are crucial for maintaining iPSC quality during scale-up.
• Optimal Culture Medium: We employ the use of advanced, chemically defined culture media optimized for iPSC growth. This provides a robust, standardized environment for iPSC expansion without the need for feeder cells, resulting in reproducible cell growth.
• Qualified Personnel: Our team consists of highly trained and skilled scientists who are adept at handling and maintaining iPSC cultures. Rigorous standard operating procedures (SOPs) are in place to ensure the consistency and reliability in our scale-up process.
• High-throughput Scaling: We utilize state-of-the-art technologies for large-scale cell production - including automated cell culture systems, bioreactors, and single-use technologies.
• Quality Control: To guarantee the quality of our iPSCs, each batch is thoroughly tested to confirm sterility, the absence of mycoplasma, and to characterize their phenotypic and functional properties. These checks include verifying the expression of pluripotency markers and assessing the differentiation potential into the three germ layers.

Based on the specific needs of our clients, we provide a tailored service including process development, protocol optimization, and batch production of iPSCs. These facilities and expertise contribute to a comprehensive, end-to-end service for large scale cultivation of iPSCs, providing researchers with the required cell quantities for downstream applications. Please note that our iPSCs and all the services related to them are intended strictly for research use, and not for diagnostic or therapeutic procedures.

Features of Our Services

• High capacity
• Specialized medium
• Superior quality
• Skilled team
• Robust data management
• Compliance

We encourage quality-focused research and strive to provide our clients with the most reliable, scaled cell culture services. We strictly offer these services for research purposes only to promote innovation and advancement in scientific exploration.

FAQs

• Q: What is the scale at which you can produce iPSCs? And how long does the entire scale-up process take?
  A: We offer a flexible scale-up process that can yield from millions to billions of cells depending on the need of the client. The timeline depends on the quantity of iPSCs needed. Our services can range from a few weeks to a couple of months. Accordingly, the exact cost depends on the size and type of iPSC strain you wish to grow. For detailed pricing, please contact our customer service team.
• Q: How do you address potential challenges such as cell clumping or differentiation during scale-up?
  A: Our team has extensive experience in troubleshooting common challenges associated with iPSC culture scale-up. We implement optimized agitation strategies, use specialized culture media formulations, and closely monitor culture conditions to minimize cell clumping and differentiation.
• Q: What level of technical support do you provide post-scale-up?
  A: Our technical support extends beyond the scale-up phase. We offer ongoing assistance with troubleshooting, optimization, and protocol refinement to ensure the long-term success of our clients' projects. Our team is committed to providing responsive and personalized support throughout the engagement.
• Q: How do you handle potential contamination issues during the iPSC culture process?
  A: We have strict contamination prevention protocols in place, including regular testing for microbial contaminants and implementation of sterile techniques. In the event of contamination, we have procedures for isolation, remediation, and retesting to ensure the integrity of the cultures.

Scientific Resources

iPSC Culture

Culture Protocol

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For Research Use Only. Not For Clinical Use.