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Process Development
Public Health England United Kingdom flag United Kingdom
Abstract ID:
Non GMP...
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We have state of the art cGMP manufacturing facilities, licensed by the MHRA and FDA at our centre at Porton Down, Salisbury for the manufacture of our own biopharmaceutical products. In addition to our own products, our manufacturing and filling facilities are utilised for the production of a wide range of clinical materials for our clients. We are able to offer customers a large range of developmental capabilities. These range from the creation of entire biopharmaceutical manufacturing schemes from research scale methodologies to the development of individual process components (eg cell bank, fermentation, purification). Our extensive experience in the controlled transfer of processes and associated methods, both within our own organisation and internationally for our clients, gives assurance of the accurate replication of such processes within a new developmental or cGMP manufacturing environment. Experience gained from the continuous improvement of our own processes enables us to offer a complete range of process modernisation services to clients including complete process redesign, introduction of disposable technology and improved analytical methods. Such activities are underpinned by the expert knowledge of our regulatory and validation teams. Our Process & Analytical Development Group design and adapt a wide range of analytical techniques to demonstrate process reproducibility and product quality.  Method qualification ensures that such techniques are fit for their intended purpose. Our clients can benefit from our extensive experience in validating our own processes and methods. Critical process and analytical method parameters are identified at an early stage in the development cycle, operating limits defined, often using scale-down technologies, and finally verified at manufacturing scale.


 

FEATURED
Last Updated Nov 2016
Technology Type
Phase of Development
GOVERNMENT INSTITUTE