Tag: <span>quality issues</span>

The United States Food and Drug Administration (FDA) considers antibodies and recombinant proteins as “well-characterized products.” This is based on FDA’s comfort level with reviewing multiple products over an extended period of time. This designation relates to the product, not necessarily to the system that is used to manufacture the product nor to the facility where the product is manufactured. The initial guidance document was published in 1995, prior to the use of other systems and when the majority of products were still based on mouse hybridoma technology that was 20 years old…