In an interview with Pharma Logistics IQ, Sanofi’s Head of Procurement for Asia, Ken Wong, spoke to Leila Hawkins about the opportunities that single-use systems provide. The conversation explored the shift to disposable equipment and how this might have consequences for sustainable approaches.
Single-use shift
When asked why drug manufacturers were shifting to disposable equipment or single-use systems, Wong suggested that “in drug development, speed is everything”. Whereas “fixed equipment” demands “capital and time”, single-use systems facilitate better “speed-to-market”. In the future, AI-assisted technology will further ameliorate the process and “single-use systems will be pivotal to this”.
The natural concern following this shift will be for sustainability. Wong suggests that, because these items are “biomedical waste”, they can’t be recycled. However, he refers to recent modelling that demonstrated that the water and energy savings of “not having to sterilise single-use equipment” might “offset the issue”.
Manufacturing hurdles
Hawkins questions Wong about the challenges that single-use equipment might present to manufacturers. His response identifies a higher operational cost for small molecule companies that produce a “high volume of generic drugs”. They are therefore less likely to make this shift. Despite this, he suggests that hybrid approaches are becoming more common where “smaller volumes” are produced.
Wong also identifies “higher demand” for single-use equipment. Suppliers are currently unable to meet this. In recent years, sub-suppliers are also struggling, so there has been a “knock-on effect on parts all the way up to assembly lines”. In addition, a driver shortage and customs delays are leading to a “new approach” in which “pharma companies produce for their region only”.
How to address these
Hawkins then asks how we can address these shortages. For Wong, they must all be resolved, whether related to raw materials, equipment, or human resources.
“My hope is that we will see a lot of suppliers expanding in different production lines and regions sometime next year.”
He also believes that these shortages are leading to “more flexibility”. The old concept, Quality-by-Design (QbD), is familiar to many. By contrast, single-use systems present a “new degree of freedom”. Wong suggests that there is global demand to “establish some guidance” for the future.
To hear more about manufacturing processes, challenges, and opportunities, come to the World Vaccine Congress in Europe 2022.
