For example, in Italy in 2011 and 2012, unconfirmed, definite and suspected cases of vCJD in blood donors

led to the recall of possibly contaminated batches of plasma and plasma products. Recalls such as these, although necessary PD0325901 to ensure the safety of pdCFCs, can also often result in product shortages, delays in supply and compulsory switching to alternative products [76]. In the 1980s, the increased demand for clotting factor concentrates, combined with concerns over the safety of pdCFCs, led to the development of recombinant clotting factor concentrates (recombinant CFCs) [92, 93]. The manufacturing and purification processes involved are designed to reduce the risk of viral PF-02341066 in vitro contamination [94-96]. There is a theoretical risk from reagents used in the manufacturing process, such as the cell culture media and growth factors, but

the most modern recombinant products do not contain exogenous animal or human components [94]. There is no evidence to date of any pathogen transmission by recombinant factor concentrates [76]. Since the late 1980s, the use of recombinant products has progressively increased, and in some European countries, recombinant products have almost completely replaced pdCFCs [97]. However, pdCFCs are still widely used, especially in many developing countries (Fig. 6) [98]. As both plasma-derived and recombinant CFCs demonstrate similar efficacy profiles, the decision of which type of coagulation factor to use is driven primarily by product safety and cost factors. selleck kinase inhibitor Cost-benefit analyses can be helpful to determine the best course of treatment in specific circumstances [89] and it is important to balance the risks and costs of plasma-derived vs. recombinant CFCs over both the short and the long term. A long-term strategy should consider the potential risks and costs associated with the transmission of viruses that may increase the prevalence of chronic conditions such as cancer and inflammatory diseases. The potential risk presented by emerging pathogens is

unpredictable and evolving. Emerging pathogens cause particular concern when there is a long asymptomatic period after infection, permitting the widespread propagation of the agent via asymptomatic carriers. In most of these cases, a clear correlation between the blood-transmitted pathogen and the disease cannot be established. For example, vCJD can have an incubation period of over 10 years, and there is no available, validated, simple, presymptomatic screening test [91]. This combination of factors makes it difficult to estimate the current prevalence of vCJD in the donor or haemophilia population. Due to increasing demands for replacement CFCs in cost-restrained environments, pdCFCs are likely to continue to be needed throughout the world.