Issue link: https://www.e-digitaleditions.com/i/1118782
38 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 P h a r mTe c h . c o m Carter (GE): Issues include logistics (including time to clear customs as goods move across bor- ders, which can counter the speed element of the single-use value proposition) and managing com- plaints or investigations on product that is over- seas. Geographical distances and language barriers can make general communication and relationship building challenging. PharmTech: What are the challenges/potential benefits of manufacturing SUS locally in Asia? Bulpin (MilliporeSigma): With the establishment of manufacturing capacity and capabilities in China, we can reduce our product lead times and help our customers bring new products to market faster. In addition to shorter lead times, end-users can carry less inventory and have an enhanced level of supply security, with the ability to source their assemblies from multiple manufacturing sites. All manufacturing sites should be working under the umbrella of a single, global quality system, and customers need to qualify the new site so that they have the ability and flexibility to receive assemblies from multiple sites Car ter (GE): Proximity to a large and rapidly growing customer base does allow us to step up our service level to our Chinese customers. One practical example is the efficiency of working in native language and local time zone, particularly for configured and customized single-use systems. Developing manufacturing operations in China to complement our existing single-use manufactur- ing network provides an added capability in how we consider and structure contingency plans to maintain business continuity even under challeng- ing circumstances. GE Healthcare published a peer-reviewed single- use system lifecycle analysis (4). The results of this analysis showed that single-use consumables pro- vide a better choice from the environmental im- pact perspective vs. the clean and re-use paradigm. The more variable aspects of the single-use life- cycle analysis and some of the more environmen- tally impactful elements of the value chain were the distribution of what are often large volume, low bulk-density products across various distances and transportation modes. Based on this study, local- ized manufacturing should have a reduced envi- ronmental impact affect; of course, there are, how- ever, diminishing returns based on manufacturing facility capacity and plant efficiency. Pora (Pall): Over the past decade, [biopharmaceu- tical manufacturing] has become an increasingly global industry. With SUS, the supply chain is complicated because, regardless of the location of manufacturing, the components are often coming from different areas of the globe. Although a lot of companies are considering moving production to other locations, with Asia having particular inter- est, questions remain. Most critically, expertise has to be there, and an often-overlooked consideration is shipping. What will the logistics look like, and how will that impact lead times? The country that any product is manufactured in will have its own resources and regulations, which will affect the ability to industrialize production. In addition to the considerations mentioned, what it really comes down to is manufacturing in locations that have the right balance between f lexibility and supply. Quality control PharmTech: What are some of the best practices in ensuring quality control of single-use consum- ables throughout the supply chain (from polymers through to the finished components)? Supply Chain