The increasing complexity of large molecule and cell-based therapeutics calls for an evolution in our understanding of the impurity and functional contributions of each formulation component.
Enhanced characterisation of critical stabilisation and lyoprotection technologies such as trehalose, sucrose, and mannitol has now moved into the realm used for active ingredients.
As a US-based current good manufacturing pactice (cGMP) producer, Pfanstiehl is now performing quantitative characterisation of several key performance attributes down to levels well beyond those required by the pharmacopeia, with the intent to share quantitative (rather than qualitative) data with formulators.
The goal is not only to provide peace of mind in terms of long term regulatory compliance, but also to remove unknowns from experimental design and enable scientists to craft more robust formulation.
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