Our Capabilities in product development

The site at Porton Down has a long history of successful development, manufacture and commercialisation of biopharmaceutical products, plus the associated analytical technologies required to support this.



 

Our 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.

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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 and qualification: Design and adaptation of analytical techniques to demonstrate process reproducibility and the product quality
  • Process and 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 down 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 GMP manufacturing environments

Our Facilities and Capabilities

  • Prokaryotic and Yeast fermentation
  • Capabilities from 2L benchtop fermenters to 100L production vessels. Cell harvesting by batch/continuous centrifugation or tangential flow filtration
  • Capabilities 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 – State of the art analytical methods including LC-Mass Spectrometry, HPLC, UPLC, electrophoresis, ELISA and dynamic light scattering
  • In Process and final product analysis – State of the art analytical methods including LC-Mass Spectrometry, HPLC, UPLC, electrophoresis, ELISA and dynamic light scattering
  • In Process and final product analysis – Forced degradation studies and stress testing

For further information on our capabilities please contact business@portonbiopharma.com  or you can download our latest Digital Brochure here