Photo: GSK Marburg
Biologics on the market
Historically, biologics were produced from a biological source, such as tissues, organs or eggs. Since the late 1970s, however, they are increasingly made using animal cell technology. By now, more than 80 biopharmaceuticals made in animal cells have received marketing approval from either the FDA or EMA. Here we present three tables listing approved products:
(1) a list of biopharmaceuticals produced with animal cell technology and approved for marketing since 1978;
(2) a list of vaccines produced with animal cell technology and approved for marketing since 1969;
(3) a list of biopharmaceuticals derived from tissues or organs and approved for marketing since 1966.
At present, new biopharmaceuticals often are monoclonal antibodies (mab’s). Here we present a fourth list, giving all therapeutic monoclonal antibodies approved for marketing since 1986 until 2017 (last update: May 2017).
Gene therapy products
ACTIP monographs and other publications
• ACTIP Information paper (last update: November 2011)
• ACTIP Position paper (last update: January 2012)
• Animal Cell Technology (last update: March 2016)
• Biotechnology and biopharmaceuticals (last update: March 2016)
• Past, present and future of monoclonal antibodies (last update: August 2018)
• Vaccines and animal cell technology (last update: June 2013)
• Safety Testing of Recombinant Protein Products Derived from Cell Lines of Human and Animal Origin (last update: April 2014)
• ACTIP 1990 – 2010 (ACTIP’s 20th anniversary publication, 2010)
• What is Animal Cell Technology
Download here a review on:
• Optimal and consistent protein glycosylation in mammalian cell culture.
By Hossler et al, Glycobiology, vol 19 no 9 pp 936-949, 2009