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Process and Analytical Development

Translating research into healthcare products

The Process and Analytical Development Group has supplied a variety of customers with a broad range of microbial products. Our great strength lies in our flexible approach and ability to translate research methodologies into production processes. Our expertise in protein analysis and enzymology mean that our products are well-characterised and of the required quality

Our services include

  • Process development and scale up
    Development of entire processes from cell bank to formulated product or individual processes
  • Non GMP manufacture
    Bioproducts that do not require GMP manufacturing facilities may still require the high level of documentation that we can provide to demonstrate process and product consistency
  • Product Characterisation
    Physical, chemical and molecular evaluation of purified product to support regulatory approval
  • Analytical Development & qualification
    Design and adaptation of analytical techniques to demonstrate process reproducibility and the product quality
  • Process & Analytical Validation
    Demonstration of the operating limits for critical process and assay parameters and verification of performance within these limits
  • Process trouble shooting
    Determination of the root cause of process failures, often using scale doewn technology, outside of the manufacturing environment in order to reduce costs and manufacturing down-time
  • Technology Transfer
    Assurance of accurate replication of a process or assay when transferred into cGMP manufacturing environments

Our Facilities & Capabilities

  • Prokaryotic and Yeast fermentation
    Capabilities from 2L benchtop fermenters to 100L production vessels. Cell harvesting by batch/continuous centrifugation or tangential flow filtration
  • Mammalian and insect cell culture
    Capabilities to 1011 cells in a variety of production platforms including Wave™, roller bottles and multilayer disposable vessels
  • Cell Processing
    Large Scale cell disruption using homogenisation, bead mill or chemical lysis
  • Product Purification
    All chromatography chemistries at scales up to 40L column volume (AKTA™ Process)
  • In Process & final product analysis
    State of the art analytical methods including LC-Mass Spectrometry, HPLC, UPLC, electrophoresis, ELISA and dynamic light scattering
  • Product stability testing
    Forced degradation studies and stress testing

For further information please contact the business development team page.

View a series of case studies: