From their beginnings more than 25 years ago, single use systems (SUS) have evolved to become a hot topic within the biopharmaceutical industry. The technology has its roots in filtration technology and blood containers, moving through simple, small-scale culture systems such as roller bottles and the use of mobile storage systems.
The growth in interest in single use systems has been phenomenal during the last ten years and this technology can be seen as a major innovative growth area for the start of the 21st century. The technology has developed rapidly and it’s now feasible to exploit single-use technology for many pharmaceutical processes for drug substance and drug product manufacturing with biologics and small molecules. Suppliers have responded to the market and end-user demand, improving their capabilities, technology offering and technical support to end-users.
Advantages frequently attributed to the deployment of SUS over classical stainless-steel systems (called multiple use systems or MUS) include improved flexibility, cost reduction and accelerated operations; i.e. faster time to market. But how does this work in practice? As for all new manufacturing innovations, the early phases of their developmental lifecycle can be more or less difficult and it frequently takes a consensus position between industry enablers – suppliers, end users and regulators – in order to help consolidate a new technology’s position.
Over the last three years there have been a number of initiatives from organizations with interests in the field such as PDA, ISPE, BPSA, ASME and ASTM, to construct guidance accommodating the practical needs around today’s regulatory paradigm, GMP, QbD and QRM.
The Parenteral Drug Association Single Use Systems Task Force is in the final stages of preparing a technical report on this subject. At a June workshop in Bethesda, PDA gave participants an opportunity to meet with the task force in order to review the technical report, with publication planned for the end of 2011.
Chaired by Robert Repetto (Pfizer) and Morten Munk (CMC Bio), the PDA Single Use Systems Task Force members include a representative panel of industry enablers who have helped to provide a balanced, well vetted and consensus driven viewpoint. The philosophical basis of approach is based on QbD principles with a detailed science and technology driven look at manufacturing strategies, technologies and system integration, business drivers, qualification and implementation.
Guided by the technical report, PDA Europe is hosting a two-day workshop on Single Use Systems for Pharmaceutical Applications in downtown Uppsala, 29-30 November 2011. On day one the workshop will provide an overview of the technical report followed by Tor Gråberg (chairman of PIC/s) who will give a regulator’s perspective. These sessions will prepare the ground for a Q&A session at the end of the day. To round off day one, delegates will benefit from a series of case studies covering the manufacture and supplier qualification of SUS and end-user perspectives on development, scale-up and manufacturing with SUS.
Day two will be held at the GE Healthcare facility in Uppsala where delegates will benefit from a site visit and an overview of important issues such as leachables & extractables (E&L), biocompatability and other SUS in-process controls – bioburden, particulates and leak testing. A CMO perspective on the ready to process system and an environmental study will equally be reviewed (more on this below). The day will be finalized with practical hands-on sessions in small groups with single use bioprocessing equipment and a look at the economic considerations for SUS.
The environmental study may be of particular interest. The presentation¹ describes a recently completed cradle-to-grave study comparing SUS and MUS for the production of monoclonal antibodies. The study considers the full process train required to produce monoclonal antibodies at 100l, 500l and 2,000l scales. The scales were chosen to reflect the clinical phase, the scale-up phase and the final production phase.
The two process approaches were compared using environmental lifecycle assessment, a systematic methodology for evaluating environmental impacts across the entire lifecycle of a product or process, from raw material extraction and refining through manufacturing, distribution, use, and ultimate disposal or recycling. Process data were derived in collaboration with BioPharm Services.
The study results show that, for the conditions explored in this study, the single-use process technology exhibits lower environmental impact in ten of the eleven environmental impact categories studied at the 500l and 2,000l production scales, and in all eleven environmental impact categories at the 100l scale.
If you are already working with SUS or are considering investing in this technology then this workshop is a must for you.
References
1. Single-use vs. multi-use equipment: An environmental Life Cycle Assessment, William P. Flanagan, PhD, Ecoassessment Leader, General Electric Company, GE Global Research and Matthew D. Pietrzykowski, MSc, PGDip, Lead Scientist, General Electric Company, GE Global Research (2011).