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Manufacturing a Clinical Trial Product (Biologics)

Good Manufacturing Practice (GMP) and stability data are essential to develop a biologics product suitable for a clinical trial.

Biologics roadmap

GMP manufacturing
GMP-MANUFACTURING:

Considerations -听Batch manufacture to GMP compliance;听Suitable product for clinical studies;听Fill finish requirements;听Reference standards for lot to lot comparison.

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听骋惭笔-叠滨翱尝翱骋滨颁:

Considerations -听Fit-for-purpose/meets TPP;听Meets release criteria;听QP release by fill/finish QP;听3 months of stability data required for IMPD/CTA.

UCL Support:

罢丑别听UCL Translational Research Group (TRG)'s听expertise and knowledge of the biologics field means that they know which GMP manufacturers are in the best position to help you to start the conversation with them.听

Contact the UCL Translational Research Group (TRG)听

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听STABILITY STUDIES:听

Stability studies for biologic therapeutics are crucial in order听to assess sensitivity to factors which could impact听biologic activity, product safety听and quality during storage.

Stability studies must:

  • Be real time/real temperature (for 5 yrs) and accelerated studies (for 12 months)
  • Be in relevant container / at relevant volume
  • Be upright and inverted containers for RT/RT studies
  • Utilise appropriate validated assays to verify physicochemical properties and purity, identity, potency,听concentration, dosage form (product) properties and safety of biologic throughout study.

UCL Support:

Specifically the Translational Research Group (TRG) within the UCL TRO, have experience in supporting UCL biologics projects, using their knowledge to advise researchers on stability study design听for therapeutic biologics.听

Contact the TRG

听