ABSTRACT
INTRODUCTION Biological Medicines and Biological Standards Biological medicines due to their inherent complexity and heterogeneity cannot be adequately characterized solely by physical or chemical means. They include bacterial and viral vaccines, blood and serum products, and other immunological, endocrinological, and cell-based medicines. Biologicals play a significant role in medicine and public health also featuring in transplantation and cell therapy programs. In addition, the growth in biotechnology-derived products has introduced the need for new reference standards for those materials that although not batch-released in a formal manner do undergo postmarketing testing and surveillance, and indeed high-quality reference materials may be invaluable in the comparison of biosimilar/biogeneric products that are now coming to the market.
