RPMI 1640 Medium is unique from other media because it contains the reducing agent glutathione and high concentrations of vitamins. RPMI 1640 Medium contains biotin, vitamin B12, and PABA, which are not found in Eagle's Minimal Essential Medium or Dulbecco's Modified Eagle Medium. In addition, the vitamins inositol and choline are present in very high concentrations. RPMI 1640 Medium contains no proteins, lipids, or growth factors. Therefore, RPMI 1640 Medium requires supplementation, commonly with 10% Fetal Bovine Serum (FBS). RPMI 1640 Medium uses a sodium bicarbonate buffer system (2.0 g/L), and therefore requires a 5–10% CO2 environment to maintain physiological pH.
For in vitro diagnostic use. CAUTION: Not for human or animal therapeutic use. Uses other than the intended use may be a violation of local law. Customers using Gibco? RPMI 1640 in a manufacturing process, who have a submission with the FDA, may request a letter of authorization from us to reference our Type II Drug Master File (DMF).
cGMP manufacturing and quality system
RPMI 1640 Medium 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, we offer an identical RPMI 1640 product made in our Scotland facility (52400-025). This facility is registered with the FDA as a medical device manufacturer and is certified to the ISO 13485 standard.