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.

PBL’s Development Group has supplied a variety of customers with a broad range of microbial products and has ISO 9001:2015 accreditation for research and development in support of biopharmaceutical products (Approval number(s): ISO 9001 – 00026911).  Our great strength lies in our flexible approach and ability to trans late research methodologies into production processes. The team’s expertise in protein analysis and enzymology mean that  products are well-characterised and of the required quality.

Mass spec
Process and Analytical Validation

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

In Process and final product analysis

In Process and final product analysis

ISO9001 UKAS Accreditation

Our Facilities and Capabilities

  • Prokaryotic and Yeast fermentation
  • Capabilities from <1L bench-top fermenters to our recently completed new fermentation suite  with four 15L vessels and a 50L vessel to enable parallel development and scale-up experiments with cell harvesting by batch or continuous centrifugation, or tangential flow filtration
  • Other capabilities include a variety of production platforms from Wave-bag™ to larger stirred tank bioreactors
  • Cell Processing – Large Scale cell disruption using homogenisation, bead mill or chemical lysis
  • Product Purification – the group has considerable expertise and in-house capabilities in preparative chromotography, protein crystallisation and TFF from laboratory-scale to 1000L
  • 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

Due to ongoing support for our own in-house products we are no-longer offering contract services, but for any other information please contact business@portonbiopharma.com