Three year project will develop a knowledge management model to help biopharmaceutical manufacturers bring new products from development to manufacture by ensuring consistency and reducing errors
The UK Department of Trade and Industry (DTI) has awarded a prestigious Collaborative Research and Development grant to a biotech consortium led by consultants BioPharm Services and supported by internationally respected biopharmaceutical companies Avecia and Cambridge Antibody Technology (CAT).
The award is made under the technology programme, a DTI business support initiative designed to stimulate innovation in the UK economy through enhanced technological research and development.
It also speeds the flow of cutting edge knowledge and ideas from the UK's science, engineering and technology base into business.
The three year project will develop a knowledge management model to help biopharmaceutical manufacturers bring new products from development to manufacture by ensuring consistency, speeding development and reducing errors.
The model optimises manufacturing processes by identifying cost effective options that minimise capital investment and maximise asset utilisation.
Project leader Andrew Sinclair, BioPharm's managing director and co-founder, has over 25 years design experience in the biopharmaceutical industry, from the first recombinant insulin process through to large scale monoclonal antibody manufacturing.
"Product development in this industry can take anything up to nine years," he says.
"We are aware that many biopharmaceutical manufacturers are failing to capitalise on the benefits of experience gained both across and within projects.
"Currently data on process, manufacturing, plant performance and costs all exist in isolation.
"We want to link those datasets to create a powerful, integrated decision support tool.
"We're developing a knowledge database and the software platform that will allow scientists, engineers, business managers and marketing people to access and use the data to support business, manufacturing protocols, validation documentation, product data and all the other documentation needed to bring a product to market".
He is quick to point out that this is not just about technology; it is also about people, supply chain management, and organisational issues, such as inconsistencies in terminology and data representation.
Sinclair and his team believe that the new software model will help to provide benchmarking of best practice, define a common terminology and methods of clearly identifying critical success factors.
Vital to the success of the project is the contribution from the other two partners, both leading companies in the biotechnology industry.
Avecia has two main operating business units: Biologics, based in Billingham, UK and DNA Medicines, based at Milford, MA, USA.
Avecia provides development and manufacturing services to many biotechnology and pharmaceutical companies, and is recognised as a market leader in microbial-based therapeutics and oligonucleotides for DNA medicines.
Based near Cambridge, UK, and Palo Alto, California, CAT is a biopharmaceutical company committed to developing human monoclonal antibody therapeutics to bring improvements to seriously ill patients lives.
CAT's core proprietary discovery technologies for rapidly isolating human monoclonal antibodies are supported by experience and capabilities in manufacturing process development, formulation and primary manufacturing.
Andrew Sinclair sums up: "We are very fortunate to be working with Avecia and CAT.
"They are at the forefront of current technology and will be providing the users' input into the model development".
"They will also be providing the all-important beta testing of the products".
Welcoming the new partnership, science and innovation minister David Sainsbury said: "This initiative provides a real opportunity to harness the world class expertise that we possess in the UK and direct it towards the task of wealth creation.
"'Biotechnology is of crucial importance in our society.
"By providing a focus for collaboration and delivery, this partnership should establish British industry as the world leader in this area and, an attractive proposition for investors."
