Biotechnology Products and Biologics

A biotechnology product is one manufactured by recombinant DNA technology, one where genetic manipulation of cells is required, or a monoclonal antibody. Applications for these products are required to be submitted through the European Centralised procedure.

Biological products are defined as so because they are more difficult to characterise or control than standard chemically synthesised pharmaceuticals.

The starting material may be human or animal tissue or of microbiological origin, but also complex bioassay system were required to monitor potency. Biologicals are blood products and vaccines, hormones, larger peptides and a miscellaneous group of tissue derived products.

SEQ can help with your regulatory requirements and life cycle management.

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