Development

Process Development is a critical aspect of product development that aims to reduce the costs, risks and timelines for projects entering GMP manufacture.

Our Process Development team will:

Adenovirus

  • define the processing conditions for the GMP manufacture of adenoviral vector products
  • ensure that the product is manufactured by a process that maintains the highest standards of product quality, as required by the European Pharmacopoeia for clinical trials
  • provide a smooth transition of novel vector products from academic research groups and collaborators to GMP manufacture

Process development studies can involve:

  • technical transfer of an existing process from labscale to a scale suitable for GMP manufacture
  • optimisation of an existing process to improve product yield
  • optimisation of an existing process to decrease time spent in the clean rooms
  • development of a new process for GMP manufacture

 

 

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Upstream and Downstream Process Development

Upstream process development studies involve optimising the multiplicity of infection and point of harvest for optimum viral replication and amplification within GMP compliant cell lines.

After harvest and lysis, the clarification steps are optimised for benzonase and/or other treatment.

Downstream process development studies involve optimising the purification steps to improve product yield and decrease product losses.

 

 

Assay Development

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Process development can optimise assays to improve process knowledge. Process development can also qualify assays to ensure that assays used for product release testing are accurate, precise and reproducible.

Stability Testing

Process development can evaluate the stability of adenoviral vector products at a range of monitored temperatures at different stages during processing. Stability testing of final purified product is performed by QC.