Gibco™ CTS™ TrypLE™ Select Enzyme, 100 mL

The Gibco™ CTS™ TrypLE™ Select Enzyme is a high-quality, animal origin-free recombinant enzyme designed for the dissociation of adherent mammalian cells. This enzyme serves as a non-animal alternative to porcine trypsin and is specifically tailored for cell and gene therapy research, development, and manufacturing processes. It ensures reliable performance and compliance with regulatory requirements, making it an essential tool for transitioning from research to clinical applications.

Key Features:

1. Animal Origin-Free (AOF):
   • Derived from microbial fermentation to eliminate risks associated with animal-derived components, such as viral or prion contamination.
2. Regulatory Compliance:
   • Part of the CTS™ (Cell Therapy Systems) product line, designed to support clinical applications with harmonized documentation, including Certificates of Analysis and Certificates of Origin.
3. High Stability:
   • Stable at room temperature (15–30°C) for up to 24 months, ensuring ease of storage and handling.
4. Exceptional Performance:
   • Comparable removal kinetics and cell recovery viability to porcine trypsin.
   • Demonstrates effectiveness on multiple cell lines, including strongly adherent cells.
5. Flexible Use:
   • Performs well in both serum-free and serum-supplemented systems.
6. Convenient Formulation:
   • Provided as a 1X stock solution, formulated in DPBS with 1 mM EDTA.
   • Phenol red-free for sensitive applications.

Specifications:

Applications:

1. Cell and Gene Therapy Research:
   • Ensures compliance with regulatory standards for cell-based therapeutic applications.
2. Adherent Cell Dissociation:
   • Efficiently dissociates strongly adherent cell lines such as CHO, HEK 293, A549, and primary human keratinocytes.
3. Clinical Manufacturing:
   • Designed to support the manufacturing of cell, gene, and tissue-based therapeutic products.
4. Serum-Free Systems:
   • Effective in dissociating cells cultured in serum-free environments, ensuring compatibility with defined culture systems.
5. Scalable Workflows:
   • Suitable for small-scale research and large-scale clinical manufacturing.

Advantages:

1. Regulatory Support:
   • Comes with harmonized documentation, including access to Drug Master File (DMF) authorization letters for FDA submissions.
2. Enhanced Cell Viability:
   • Maintains high recovery viability during dissociation, reducing stress on sensitive cells.
3. Room-Temperature Stability:
   • Simplifies storage logistics and eliminates the need for refrigeration.
4. Eco-Friendly Manufacturing:
   • Sustainable packaging and processes align with green research initiatives.
5. Reliable Consistency:
   • Manufactured under strict cGMP standards to ensure lot-to-lot reproducibility.

Protocol Overview:

1. Pre-Warm TrypLE™ Select CTS™:
   • Warm the enzyme to room temperature before use.
2. Prepare Cells:
   • Wash adherent cells with PBS or equivalent to remove residual serum.
3. Apply Enzyme:
   • Add enough TrypLE™ Select CTS™ to cover the cell monolayer.
4. Incubate:
   • Incubate at 37°C for 2–5 minutes, monitoring for cell detachment under a microscope.
5. Neutralize:
   • Dilute with complete medium to inactivate the enzyme.
6. Centrifuge and Resuspend:
   • Centrifuge cells and resuspend in fresh culture medium for further applications.

Ordering Information:

Storage and Handling:

• Primary Storage: Store at 15–30°C, protected from light.
• Alternate Storage: Store at 2–8°C or -5°C to -20°C for extended stability.
• Shelf Life: 24 months from the date of manufacture.

Related Products:

• Gibco™ CTS™ DPBS: For washing cells before dissociation.
• Gibco™ CTS™ OpTmizer™ Medium: For culturing cells post-dissociation in serum-free conditions.
• CTS™ TrypLE™ Express: Alternative recombinant enzyme for adherent cell dissociation.

Regulatory and Manufacturing Notes:

• Compliance:
  • Manufactured under ISO 13485 standards.
  • FDA-registered facility adheres to 21 CFR 820 regulations.
• Documentation:
  • Includes Certificates of Analysis and Certificates of Origin.
  • Authorization letters for Drug Master File (DMF) submissions available upon request.

The Gibco™ CTS™ TrypLE™ Select Enzyme provides a high-quality, animal origin-free solution for dissociation workflows in cell and gene therapy research and manufacturing. Its performance, regulatory support, and ease of use make it an essential tool for transitioning from research to clinical applications.