Top 16 Articles About Algae

Beta-glucan contamination of pharmaceutical products: How much should we accept?
In patients with cancer (the intended patient population for the CRUKD/14/001 trial), possible immunostimulatory and/or direct anti-tumour effects of beta-glucan contaminants would, if anything, be considered desirable from a patient benefit perspective. However, in this first-in man, first-in-class, proof-of-concept trial, it is important to ensure that any anti-tumour efficacy observed is due to therapeutic MOv18 IgE itself. Moreover, for biotherapeutic agents developed for non-oncology indications, immunostimulatory effects would not necessarily be desirable. Based on currently available data, a limit of 10 ng/mg (or 500 ng total dose) of beta-glucans seems unlikely to provoke any clinically significant immunological effects and this level may be acceptable for medicinal agents.