Reflections on Covid-19 inbound supply chain issues
The survey asked questions on quality systems, supply chain resilience, second sourcing and relationship management. A final open question also allowed biomanufacturers to raise any other areas of interest or concern they wanted to share with the supply base.
There were 34 individual and 29 company responses across 25 biomanufacturers and four suppliers, and there were some strong emerging themes from the replies.
Quality management system interaction
The first was a strong perception across many survey respondents that interactions between biomanufacturers and suppliers at the quality management system level are not optimal. Specific comments said that delays in supply change notifications are often too late to plan for, that suppliers and biomanufacturers may have different standards in quality systems, and there is a need for proactive communication about changes.
“Interactions are unlikely to ever be classed as optimal and so will be an ongoing need,” said Bob Brooks, BioPhorum Supply Partner Leader. “But the survey shows the strength of feeling at the current time and that people understand that more work needs to be done in this space.”
Supply change notification
As well as the need to improve document harmonization and validation, supply change notifications were seen as a significant area for improvement. Respondents were concerned about the volume of change notifications, how they could be better managed, if there was a way they could be processed more quickly and whether the process was as efficient as possible.
“There has obviously been an increase in the number of supply change notifications being raised during the pandemic as people looked for alternate sources of materials when things became unavailable,” Brooks explained. “Biomanufacturers have often been swamped with these increased numbers, so maybe industry should look for a better way of dealing with them. This is why BioPhorum has recently published two papers on supply change notifications, one on single-use systems and the other on raw materials.”
When thinking about what significant changes are needed across the biopharmaceutical industry, respondents’ comments included the need for best practices on supply chain resilience and consideration of the impact on industry-wide planning and sourcing strategies.
Identifying supply chain bottlenecks was also a common survey concern that could affect industry’s rapid scale-up – followed by their impact on sourcing strategies.
“The extra stress put on the inbound supply chain by the pandemic has created some interesting bottlenecks that may have been a surprise to some,” said Brooks. “Over the evolving pandemic, PPE was in short supply at the start and then later some basic chemicals and salts. There is also a prevalent issue on the availability of single-use system components and increasing lead times, which led to lots of shared investment by major supply partners and biomanufacturers. There are also some concerns over other raw materials, such as amino acids.
“Raw materials availability is a particular concern in the Supply Partner Phorum and is reflected in our program of work,” Brooks added. “For example, the work of the Risk & Business Continuity Management Workstream is guiding industry toward a more consistent, structured approach to risk management – not only those companies that directly support manufacturing but those who source raw materials and are involved in warehousing and distribution.”
The survey feedback is hugely valuable to understand transparency in the supply chain, maybe at Tiers 2 and 3. “As the pandemic lockdown start to impact, people quickly understood what materials were in immediate short supply,” added Brooks. “Single-use system components that were already stressed then became extremely short in supply and were often being allocated at a national level. Similarly, other raw materials suffered significant disruptions to their supply and availability. If we can find where the bottlenecks are, we can mitigate against them for when we might need to do a rapid scale-up again.”
The survey found that actions taken by biomanufacturers included changes in inventory policies, fast-tracking the acceptance of alternative sourced materials, and developing multiple secondary suppliers.
“There was valuable information shared by the biomanufacturers on the things they have been doing in light of the pandemic. Anecdotally, we have heard that some biomanufacturers have started more second-source projects in the last 12 months than in the previous three years. They are clearly ramping up their ability to source materials. Informally, we knew about many of these biomanufacturer actions; still, it is good to have these actions qualified by the survey and that the industry is sharing this level of information.”
The survey highlighted multiple priorities to drive lasting industry improvements, such as future facility build and design strategies, and supply chain resilience projects; particularly, BioPhorum’s Alternative to Gamma project.
“We see moving from the pandemic to the endemic as being a catalyst to transform the inbound supply chain and is an opportunity for investment and development,” said Brooks. “There is some genuine interest in where new facility builds might be located, the design of those facilities and the concept of supply chain resilience.”
Specific comments on supply chain resilience included the need for greater transparency from both suppliers and biomanufacturers to understand demand forecasts and supply, that now more than ever industry should come together to drive standardization, and the lack of visibility on orders and last-minute changes have an impact on the manufacturing schedule.
Brooks explained that “We do not yet fully understand what might happen when the pent-up demand for the consumption of raw materials is released as clinical trials start up again, drug production comes back online, and new projects start. Industry’s multiple priorities show that we need to drive lasting improvement into our supply chains so that we can meet future needs.
Brooks said the supply chain resilience issue was highlighted in the survey respondents’ interest in a BioPhorum tactical project – Alternative to Gamma. “There is a potential future constraint in the limited availability of gamma sterilization capacity, so x-ray is being added as a complementary technology. But we need to ensure that industry can accept x-ray technology, we have the correct data packages to support its use, and that we can relieve any pressure in our supply chain, particularly for single-use system components that are all currently gamma sterilized.”
With a critical mass of more than 60 members from more than 30 biomanufacturers and a similar number of supply partners and key suppliers, BioPhorum Supply Partner has realized that it must own the inbound supply chain. As a result, it has collaborated to create a Strategic Framework for the development of the inbound supply chain – a first for the biopharmaceutical industry. This is an exciting time for the inbound supply chain and the survey results are a vital feeder to that framework.