For the last 25 years there has been a significant shift in biopharmaceutical manufacturing from labour-intensive processes to full automation with ready-to-use separation devices. The next phase, according to Millipore, will be focused on disposable technologies in all areas of bulk drug manufacturing and sterile fill and finish operations.
One company that shares this view of the future is DSM Biologics of the Netherlands, which has been working with Millipore on implementing disposable manufacturing systems in its production processes.
Peter Ketelaar, DSM Biologics' director of new business development, said that the company already has experience with disposables when producing volumes up to 1,000 litres.
"We have found that the use of disposable manufacturing techniques when building and operating a CMO [contract manufacturing organization] facility have resulted in lower initial investment and increased flexibility, allowing a fast changeover and line clearance," he noted.
With increasing demands on capacity and pressure to reduce capital spending, companies responsible for large drug development pipelines, contract manufacturers and biotechnology start-ups are prime candidates for the adoption of disposable systems and technologies, claims Millipore.
The first phase in the completely disposable manufacturing evolution is a hybrid stage, where the integration of disposable technologies with existing stainless steel processes is required and the integrity and quality of a drug product during sampling or liquid product transfers is maintained. Millipore's ultimate vision, however, is of a 'Plastic Factory', i.e. a manufacturing process that is constructed entirely of disposable single-use flow paths for formulation, sterile filtration, and final fill and finish.
This offers potential benefits in reducing the need for heavy capital expenditures; eliminating extensive validation and cleaning procedures, reducing the risk of cross contamination and providing for rapid changeover of processes in multi-product manufacturing plants. Millipore estimates that adopting these approaches could reduce the time to clinical market by 30 per cent.