Explanation of Prototype Status
Prototypes are products developed by Life Technologies for which development has not yet progressed through the complete new product introduction process. Prototype media are produced under current good manufacturing practices (cGMP) conditions in our Grand Island, New York, facility and tested to meet development specifications, but lack extended shelf-life testing (>12months). Prototype status means that these products are currently undergoing real-time stability studies in compliance with cGMP and internal policies. Once the studies are completed, these media will be converted to catalog products and will no longer be considered prototypes.
New product development is an interactive, customer-driven process that helps ensure our new products address customer needs. To provide our customers with rapid access to innovative products, Life Technologies makes prototype products available following the guidelines of a standard operating procedure in compliance with cGMP regulations.
Commitment to Quality
Life Technologies is a leader in quality, innovation, and capacity. From how we manage our core quality processes to our investments in risk management, we are dedicated to operational excellence in everything we do. We are committed to your success. By maintaining a standard of unassailable quality and continuous process improvement, our quality-management systems and policies are designed to meet your ever-changing needs. With our global reach and business expertise, our comprehensive technological solutions can help improve your workflows worldwide, so you can focus on research and discovery. Our quality systems and processes help ensure our success in meeting your needs, and include:
- ISO 9001 or ISO 13485 and FDA-certified facilities
- cGMP-classified sites
- Auditing by major biopharmaceutical and diagnostic companies
- Employment of Six Sigma and lean manufacturing to ensure for top-notch quality and lower costs