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BioDuro provides complete CMC services for small molecule products from pre-formulation through clinical supply. Our pre-formulation solutions incorporate chemical and physical characterization with biological characterization such as Caco-2 permeability and small animal DMPK. Supported by integrated project management, our extensive pre-formulation program elucidates candidate attributes to drive decision making in formulation development, helping predict the best formulation approach.
Our studies determine physical, chemical and biological properties of candidate drug substances to aid in the determination of the optimal formulation path for the candidate. Testing for this includes:
Our state-of-the-art technologies include: