Biopharmaceuticals and Regenerative Medicine

• Lonza Biologics has significant expansion plans for its antibody contract manufacturing business at Slough. As part of this, eXmoor pharma was asked to determine when current WFI capacity would be exceeded and to advise on solutions to meet any shortfall.
  
  Martin Smith and Andrew Provan from eXmoor developed two interlinked models, one for the process and one for the WFI usage. Once the models were validated and checked with current real world data, the models were adapted to look at future production plans. With extensive challenging of the model, they determined that the existing WFI generation and distribution system was sufficient to cope with changing demands of the process and regulations for the next five years.
  
  This reassurance meant that immediate and significant capital expenditure to upgrade the capacity of the system was not required, thereby saving Lonza considerable sums of money, and disruption to production caused by changes to the WFI loop and generation.

• eXmoor pharma welcomes Andrew Provan who joined on the 1st Feb from Bovis LendLease. Andrew has 24 years experience in the biopharmaceutical industry working in manufacturing, design,  construction, qualification and consultancy.  He specialises  in bioprocess design, clean utilities and CIP, areas in which he has lectured and run training courses for ISPE and IChemE."
  
  
• eXmoor pharma wins contract to start-up and manage new Regenerative Medicine Facility in the NHS.
  eXmoor pharma has been awarded the Management of the Biomedical Research Centre GMP Facility contract by Guy’s and St Thomas’ NHS Foundation Trust. This prestigious contract covers the operational management of the new GMP Cell Therapy Facility from before practical completion through the start-up phase and into the manufacturing and development activities to be carried out by the facility’s customers leading to licensing of the facility by the MHRA. This contract continues eXmoor’s involvement with the Cell Therapy Facility which began in July 2007 working with the Users to develop the User Requirement Brief. eXmoor then carried out the concept design, process design and GMP compliance activities, working alongside the Project Design Team to ensure that the particular requirements of the Cell Therapy Facility were met. In parallel we worked with the Users, to prepare them and their processes for a move in to the new facility when complete. Bringing the facility into beneficial operation completes the picture and we are very pleased to have been given this opportunity.