cGMP Manufacture

Avecia has two multi-product, cGMP facilities, ABC 1000 and ABC 5000, to produce cGMP material to support all phases of clinical development through to licensed product manufacture.

These facilities are MHRA inspected and provide:

• four cGMP streams for the manufacture of microbially derived biologics
• capacity from 100L to 5000L
• flexible, multi-product manufacture

These facilities have successfully manufactured over 30 protein therapeutics for use in human clinical trial.

Cell Banking

ABC 1000

ABC 5000

Stability Studies

Avecia provides cGMP stability studies to support its customers drug development programmes. These can be provided for both drug substance and drug product and offer a substantial saving in sub-contractor management time.

Avecia’s cGMP stability testing capabilities include:

• protocol generation
• ICH and non-ICH conditions
• wide range of analytical assays
• aAccelerated testing and degradation