Disposables – Suitability and Process Economy In Biopharmaceutical Manufacturing – A Reality Check
08th February 2018 | 10 AM Central European Time/ 9 AM GMT | Joachim Walter |WATCH FOR FREE
Since the introduction of disposables and gaining popularity of Single-use Technology (SUT) for biopharmaceutical manufacturing there is nevertheless an ongoing controversial discussion on the advantages and disadvantages versus a conventional stainless steel environment.
In a “classical” facility design any validation cost effort can easily be distributed to a considerable number of production runs thus contributing only to a non-decisive amount to the overall production costs. The scale for such plant is nearly unlimited as is the scale of operation. The “flexible” approach using disposables and single-use equipment offers significant advantages regarding changeover work and time thus a high throughput of different processes will definitely take profit as any cleaning and related validation and costly analytics doesn’t apply to a larger extent.
Despite the potential benefits loudly advertised by the respective industry, these potential advantages derived from single-use equipment and disposables can be significantly diminished by lack of detailed process cost analysis, missing economic analysis and cost comparison between conventional and SU technologies as well as underestimating the cost of long term dependency on consumables. Due to missing appropriate standards, there is a widely non-compatibility between the equipment and consumables of the various suppliers, resulting in a strong dependence on the consumables of a single supplier once a single-use equipment has been purchased, curiously leaving some customers with surprise that they hardly have any room for price negotiations on the required consumables.
This paper’s focus is on the very different arguments for the application of SU equipment and consumables, including advantages and limitations of SUT, understanding improvement of process robustness, contribution to lean production as well as environmental impact of disposables.
Dr Walter got his education and PhD at the RWTH Aachen, Germany, and started his industrial career at Boehringer Ingelheim, Germany, in 1985. For nearly 18 years he was responsible for Process Development Downstream Processing, including four different scientific groups engaged in the development of downstream processes at laboratory scale, scale up and the cGMP manufacture of clinical grade biopharmaceutical proteins for clinical phases I and II in a 2,000 L pilot plant. Other important areas of work were the development of methodologies and processes for viral clearance as well as the planning and performance of validation studies for viral clearance. Beside such process related activities, the groups worked on the design, development and implementation of technical equipment for downstream processing of biopharmaceutical proteins.
In 2002 he accepted a management position at GE Healthcare, USA, as Unit VP Membrane Separation Sciences. He supported scientifically the establishment of new businesses such as Membrane Separations and Single-use Technology for GE Healthcare regarding industrial and regulatory requirements and applications in biopharmaceutical development and production processes.
While operating Walter Biotech Consultancy since 2006, in 2009 to 2012 Dr Walter cooperated with Innobiologics, Malaysia. As acting SVP Biopharmaceutical Operations at Innobiologics he was responsible for three departments including Process Sciences, Biomanufacturing and Facility Engineering and successfully brought Innobiologics’ facility into cGMP operation.
Since he has been deeply involved both in supervising production processes and in the planning and construction of biopharmaceutical facilities in China and Turkey.