Boom time for bio-outsourcing
contract biomanufacturing organisations (CBMOs) that specialise in
the production of biopharma products, is rapidly expanding.
By 2008 over 50 per cent of biopharma companies will outsource at least some aspect of their biomanufacturing activities, up from 35 per cent in 2004, according to a report from UK business intelligence firm Piribo.
This is because by its very nature, biomanufacturing is a very complex, costly and labour-intensive process and these factors, coupled with ongoing labour shortages and staggering costs of building biomanufacturing facilities, are forcing many biopharma firms to turn to outsourcing for help as they struggle to make enough product to meet escalating demand.
However, the report, titled "Developing and managing successful bio-outsourcing relationships" warns biopharma firms that they must be sure that any CMBO they choose to partner with is the "right fit" for their company.
There are four main categories that sponsors and contractors must pay close attention to when developing a successful bio-outsourcing partnership, said the report.
These include the CMBO's process management of all the activities associated with the manufacturing process; its performance, including the process deliverables promised; the organisational structure of the company and its project teams; and the information systems that the CMBO plans to use to manage data flow and ensure secure data transmission.
Once a CMBO is chosen, the report also stresses the importance of a successful technology transfer between the two companies to ensure that the manufacturing process developed by the sponsor can be exactly duplicated at the new contractor's site.
In particular, biopharma companies are warned against having unrealistic expectations of the time required for this technology transfer to take place, and in doing so, avoid laying down a rocky foundation right from the start.
