Biological Products Production and Development

Biotherapeutics are biological products derived from human, animal or bacterial proteins, blood components or extracts that have medicinal value.

Antibodies are often generated using animals as hosts for an antigen towards which an antibody is needed. There are, however, ways of generating antibodies or molecules showing similar properties but using fewer and sometimes no live animals. These include phage, yeast and ribosomal display methods and using egg yolk IgY instead of animal-derived IgG or IgM antibodies. Furthermore, the ascites method of amplifying antibody yields within animals has been contested by FRAME as being largely unneccessary, given that equally effective methods of amplifying antibody yields are possible when using cell culture based methods.

Other biological products include botulinum toxin, insulin and other hormones and vaccines. Each of these products are produced in batches and some products are still produced in animals.

As these products are produced in batches, each batch can differ from another and have regulatory requirements that the activity and safety of each batch is confirmed. Ultimately, this can require the use of much more animals than is the case for chemical drug testing.

Animal tests currently used include pyrogenicity testing for bacterial contamination, local tolerance testing as well as other safety and efficacy tests common to non-biological medicines.

Pyrogenicity testing in rabbits is being replaced by a test based on human blood and FRAME is keen to see alternatives to other tests such as the local tolerance test being used.

FRAME's activities

FRAME is looking at alternatives such as local tolerance testing and microdosing studies in humans as well as how computer and cell-based and methods and analytical techniques can be used during batch testing.