Manufacturing, regulatory and commercial challenges of biopharmaceuticals production: a Finnish perspective

Eur J Pharm Biopharm. 2005 Apr;59(3):397-405. doi: 10.1016/j.ejpb.2004.11.006.

Abstract

Biopharmaceuticals product development is a broad and multidisciplinary field. Science and technology are combined with new manufacturing, regulatory and commercial challenges. However, although there is ample literature on the molecular biology and biochemistry of products, the implementation of processes from test tube to commercial scale has not received similar attention. Consequently, the present study aims to highlight, from practical point of view, some of the key issues involved with manufacturing technologies of biopharmaceuticals at a commercial scale. Regulatory requirements and investments are also addressed based on the practical experiences of start-up and small companies. Finland is used as a case-example of such companies as this is a EU-member state with strong technological growth and rapidly increasing number of biotech companies.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biopharmaceutics / economics
  • Biopharmaceutics / legislation & jurisprudence
  • Biopharmaceutics / trends*
  • Biotechnology / economics
  • Biotechnology / legislation & jurisprudence
  • Biotechnology / trends
  • Drug Industry / economics
  • Drug Industry / legislation & jurisprudence
  • Drug Industry / trends*
  • Drug and Narcotic Control / economics
  • Drug and Narcotic Control / legislation & jurisprudence
  • Drug and Narcotic Control / trends*
  • Finland
  • Humans