Life Technologies offers a variety of trypsin formulations and animal origin-free TrypLE™ reagent that feature:
- Quality Testing
- Documented Traceability
- Dual-site cGMP Manufacturing
This trypsin solution is modified as follows:
|• Phenol Red|
The complete formulation is available.
Gibco® Trypsin solutions are tested for pH, osmolality, sterility, and performance. In addition, prior to manufacturing, the raw materials are verified for e-beam irradiation and tested for endotoxin, PPV, PCV 1/2, mycoplasma, bacterial, fungal, and viral contamination, as well as multiple activity assays, ash analysis, and moisture analysis.
Life Technologies can provide detailed documentation to meet your regulatory needs. Gibco® Trypsin information available includes lot traceability, animal origin certificates, lot analyses, irradiation certificates, a viral inactivation summary, and supply chain transparency.
cGMP Manufacturing and Quality System
Gibco® Trypsin is manufactured at a cGMP compliant facility, located in Grand Island, New York. The facility is registered with the FDA as a medical device manufacturer and is certified to ISO 13485 standards. For supply chain continuity, Life Technologies offers a comparable Gibco® Trypsin solution made in our Scotland facility (25200-056). This facility is registered with the FDA as a medical device manufacturer and is certified to the ISO 13485 standard.