The impact of the European Pharmacopeia Regulations for peptides during the change of manufacturer at late phase
The regulations controlling the use of synthetic peptides as therapeutics has changed significantly over the last number of years with peptides now being viewed as closer to small molecules in terms of process control, structural characterisation and individual impurity limits. This can become challenging as peptides move through clinical development, and further complicated if a new manufacturer is tasked with preparing material that is of a higher quality than previously produced, with little information as to how the peptides were manufactured previously.
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Almac Sciences provides integrated services from development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API).
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