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Batch Release Services – Large Molecule Formulations

Biologics differ from chemically synthesised drugs in a number of ways which impacts on their cost, manufacture and routes of administration.

Differences between Small Molecules and Biologics

Small Molecule DrugsBiological Products
Generally low molecular weightGenerally high molecular weight
Usually organic or chemicalMade with/from live cells/organisms (inherent & contamination risk)
Fewer critical process stepsMany critical process steps
Well-characterisedLess easily characterised
Known structureStructure may or may not be completely defined or known
Homogeneous drug substance Heterogeneous mixtures (which may include variants)
Usually not immunogenicOften Immunogenic

 

The level and complexity of the testing required is dependent on two primary factors, the product indication and nature of the product more specifically the source and level of control of the raw materials, the complexity, robustness and level of control deployed during the manufacturing process, the chemical complexity of the drug substance, the chemical complexity of the drug product and the reliability and complexity of the methods used to evaluate identity, purity, and potency of the drug substance and the drug product.

Tepnel has extensive experience in the lot release testing of biologics, specifically proteins, vaccines and anti-allergenics.

Testing available for biologics:

Sections in Batch Release Services

All Batch Release Services

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