The manufacture of blood plasma products in Scotland: a brief history.

A number of essential clinical products are derived from human blood plasma, including immunoglobulin products for the treatment of infections and disorders of immunity; albumin for protein and fluid replacement and coagulation factors for the treatment of haemophilia and other disorders of haemostasis. For many years, these protein pharmaceuticals were manufactured by the Scottish National Blood Transfusion Service (SNBTS) at its Scottish Protein Fractionation Centre (PFC) in Edinburgh, a contribution which ended with the closure of the PFC in 2008. The origins and development of plasma fractionation in Scotland are summarised in this article, as well as issues which contributed to the closure of the PFC.

Selection of spiking materials for studies on the clearance of agents of transmissible spongiform encephalopathy during plasma fractionation.

Manufacturers of plasma derivatives are encouraged to perform product-specific investigational studies on the ability of their processes to remove prion agents. Such studies are invariably performed using spiking materials derived from infected brain tissue. However, there is little guidance available on which preparations are suitable and no consensus on the acceptability of resultant data.

Design of a UV-C irradiation process for the inactivation of viruses in protein solutions.

The ability of ultraviolet (UV) light to inactivate viruses is well established. However, attempts to apply this to the manufacture of pharmaceutical proteins have been limited by incomplete treatment, low capacity or excessive dilution. Effective processing of large-scale batches of UV-opaque protein solutions has been achieved using a continuous-flow device.

Effect of freezing and thawing rates on denaturation of proteins in aqueous solutions.

The freeze denaturation of model proteins, LDH, ADH, and catalase, was investigated in absence of cryoprotectants using a microcryostage under well-controlled freezing and thawing rates. Most of the experimental data were obtained from a study using a dilute solution with an enzyme concentration of 0.025 g/l.