Trends, challenges and priorities
If industry is to adjust to the new normal as it moves from ‘pandemic to endemic’, it needs to help solve the most important issues over an appropriate timeframe and strengthen and advance inbound supply chain operations to benefit patients globally.
The WHO announced the official end of the COVID-19 Pandemic on the 05 May 2023, but it has also set a challenge for us all to be ready for the next pandemic in 3-5 years time.
If we can look at the things that happened as this Pandemic evolved over time – how supply chains were impacted and disrupted, what things we learnt and put in place during the pandemic to help make things easier – then we can assess if another pandemic were to happen would the evolution over time happen in the same way and would the same disruptions to the supply chain happen?
We are all aware climate change is negatively impacting the environment and human health. It has been implicated in helping to create the conditions by which pandemics may be initiated as animals and the pathogens associated with them find new habitats as a result of global warming.
There has also been an increase in concern over Sustainability relating to man-made chemicals and their impacts on the environment, and human and animal health UN Sustainability Goals are high on the agenda after COP26 & 27 and the upcoming COP28.
Public and Political pressure is driving accountability to manufacturers to demonstrate how they are taking responsibility for the materials they use and the processes they operate – this is impacting the biopharmaceutical industry with recent proposals for rule changes for ‘materials of concern’ like PFAS, EtO and Nitrosamines
Lessons learned include:
The importance of de-risking supply chains for both suppliers and biomanufacturers by applying the principles of risk and business continuity management and looking for sources of products that can be supplied from multiple regions of the world to the same quality standard requirements.
Where possible not to include too specific detail in filings for biotherapeutic products that restricts the ability to be agile and swap in and out products that can do the job needed to be done in the production process.
BioPhorum members continue to use the lessons learned during the pandemic and in the post pandemic world to further drive improvements in the global supply chain and continue moving towards becoming one of the best understood and best managed supply chains in the world.
Resilience is about recovery
The supply chain is still impacted by ongoing issues post pandemic, geopolitical and others, that cause logistics and transportation disruptions, from shipping bottlenecks to limited labor, and regional issues like Brexit. New capacity is coming on-line to help with single-use systems (SUS), chromatography resins and filter manufacturing all of which will put the supply capability of the industry in good stead. However, changes in the external environment persist in causing disruption and cause on-going limited availability of some raw materials. In addition to this the materials of concern challenge creates further pressure within our industry.
BioPhorum Supply Partner members want to continue to develop and promote solutions that alleviate these issues, things that reduce risk and increase agility for our members and continue to build in areas such as increasing forecast and demand planning best practices, risk and business continuity management, knowledge and mapping of the supply chain to promotion of the joint audit approach.
Focus on solutions
BioPhorum Supply Partner has continued to focus on the inbound supply change, making raw materials more available and improving operational processes such as supply chain notifications. We have collaborated with BioPhorum Drug Substance to publish a paper.
BioPhorum approach to the registration of innovative raw materials using the Quality by Design principles that can be used by the industry. Our Supply Chain Quality Management workstream team published an electronic template to support the need for increased speed in processing second source supply change notifications.
Technical single-use plastics are driving the industry forward; however, the increase in demand for these products also increases the need for more sterilization capacity. The Phorum is actively working to promote x-ray technology as an acceptable sterilization process across the industry, which can be used as a complementary approach with gamma radiation. Our support has led to the FDA having recognized x-Ray as a complementary technology for the delivery of the method of sterilization which is ionizing electromagnetic radiation. This will help to offer another channel for sterilizing the industry’s SUS componentry.
Strategic framework
BioPhorum member companies want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best understood and managed global supply chains. As part of this journey, the team developed a strategic framework for the development of the inbound supply chain. Members wanted to focus on what is important to the industry and realized that many issues were apparent even before the pandemic began. They identified five strategic objectives that focus on fundamental problems within the industry and outlined approaches to address these problems. The group has developed maturity/capability assessments for each of the five strategic objectives using an approach to help members to be able to use tangible methods to improve their performance against the objectives and that allows for the measurement of performance to ensure that they are increasing value from improving operational excellence in terms of quality, speed, agility, and resources to members, industry, and ultimately patients.
The strategic goals developed by the group are:
- Led by market/industry insight – understanding supply chain trends regionally and globally through market insight and intelligence.
- Providing safety, resilience and quality – building safety, resilience, and quality by working in harmony with manufacturing.
- Underpinned by end-to-end digitalization – the in-bound supply system must be able to support the continued investment in manufacturing process automation and electronic systems occurring throughout the industry, such as ILM/RTR. The suppliers need to move beyond simple transactional electronic data interchanges to electronic data exchange (EDE) by understanding the process parameters by which raw materials have been made as well as the testing methods, and how this can be used by manufacturers and compiled into electronic batch records.
- Open and transparent – promoting a more open and transparent supply chain to improve quality and decrease risk, while remembering that ultimately, the industry exists to support the patient.
- Responsible and sustainable – encouraging a responsible and sustainable supply chain that is safe for humans and the environment.
Members recognize that we are not only a trusted advisory group, but also the engine that is driving change for the industry. They understand that the objectives need to be applied by a collaboration of companies across all types of suppliers, from those involved in raw materials to those that play a role in getting medicine in a primary container. The team is enthusiastic about these objectives, especially since they resonate with many corporate objectives. By meeting these objectives, we will continue to move the industry forward and create a supply chain that is appropriate and fit to serve the industry and the patients that rely on it.
Supply Partner deliverables June 2022 to June 2023
Filter by workstream
Milestones
An Industry Long-Range Planning Approach
This workstream was commissioned in June and has been working to further refine the draft charter, to test the business benefit premises of the workstream and develop the recruitment deck to enable the recruitment of the right Subject Matter Experts (SMEs) to deliver against the intention of the Charter developed by the Phorum Leadership Team. SMEs are being recruited now and the workstream is moving to the ‘design and development’ of the deliverables that will turn the charter into a tangible deliverable for members to implement.
Alternative to Gamma Sterilization
This has become an established workstream in the Phorum. It has recruited SMEs and is working through a change roadmap. This supplier and biomanufacturer partnership team is developing a partnership approach to the introduction of x-ray, alongside gamma irradition for single-use systems and single-use technologies.
Working in tandem with a Bio-Process Systems Alliance research project, it is raising awareness of the case for change and education around x-ray, through a lay introductory guide and rejoinder webinar events. It is also leveraging BioPhorum and BPSA’s Change notification best practice, to roll out a smooth and industry wide adoption of x-ray as an alternative sterilization modality.
Biopharmaceutical Manufacturing Industry's Strategic Framework for the Development of the Inbound Supply Chain
BioPhorum Supply Partner Leadership Team commissioned a Governance Task Team to deliver a strategic framework for the development of the inbound supply chain for the biopharmaceutical manufacturing industry. This was created and shared back to the full Leadership for approval in June 2021.
The Governance Task Team are now working on the development of the maturity models for self benchmarking progress against the five strategic objectives of the framework. This will be used to reference benchmark individual members and the industry in 2022 and to report on progress in moving towards the strategic objectives over the next five years.
Electronic Data Exchange (EDE) /Digitization of the In-bound supply chain
This workstream is moving from its plan to implementation phase. It is exploring the importance of electronic data exchange within the inbound supply chain, particularly using the existing ASTM E3-77-17 data standard.
Throughout 2021, the workstream has been scoping the context and use cases for EDE, resulting in an introductory video about how EDE is a cornerstone for a wider Pharma 4.0 vision. The team has also carried out a baseline survey across BioPhorum companies on the adoption of EDE and the ASTM data standard. The results are soon to be published, but show that the industry still has a long way to go to adopt and accelerate EDE across the inbound supply chain. To support this acceleration, the workstream is now adapting BioPhorum’s digital plant maturity model, to scope and adapt the stages of EDE adoption across the supply chain, informed by its EDE partner pilots.
Forecast and Demand Planning
This team’s goals are to define a common way of working for priority forecast and demand practices in the inbound supply chain for single-use sytems and mammalian cell culture media, and encourage the adoption of common practices across the industry to improve the overall
standard of forecasting practices.
The three focus areas have been:
- The Forecasting Process and Content team, which has been focused on outlining the recommended critical steps and key content required to deliver a useful forecast.
- The forecasting template was published in in Q4 2020, and an accuracy calculator published in Q3 2021
- The Forecasting KPIs team, was focused on how to measure the accuracy of a forecast and provide guidance for key metrics, e.g. OTIF. Guidance on this is complete.
There is now a focus on implementation of these best practice tools and understanding how to adjust to the challenges of forecast and demand planning under a pandemic/endemic situation with servere supply chain disruptions.
Risk and Business Continuity Management
Covid-19 has highlighted the vital role that effective risk and business continuity has within the supply chain. The need for globally distributed supply chains to be resilient has made some look at their global, regional and in-country strategies. The best practice guide seeks a more consistent approach to evaluating the supply base and industry approach to risk management. This is stage one of the overall workstream deliverables. Stage two builds on this and seeks to agree and publish an Industry guide to effective business continuity management with both documents underpinned by the workstream looking at supply chain mapping as a foundation to increasing the surety of supply.
Senior BioPhorum Connect – Major Supply Partner sessions on capacity and agility
Between February and June 2021, BioPhorum facilitated regular sessions where the Major Supply Partner members of BioPhorum were able to share with the Senior BioPhorum Connect their response to the rapid increase in demand driven by the vaccine response to Covid-19.
MSP members shared their capacity expansion plans on their global networks building in multi-regional capacity and the ability to make the same products in multiple regions to the same quality standards – new approaches to speeding up supply chain processes that allow for the increased capacity to alleviate supply availability issues were also shared. This was well received by the biomanufacturer members of the Senior BioPhorum Connect – helping to build confidence that the supply base response is on-going and significant.
A survey of SBC members has also been conducted about the their perceptions of where change is needed in supply chain practices and interactions between suppliers and biomanufacturers. This was shared at the June 2021 meeting along with the phorum strategic framework.
Supply Chain Podcast
We have recently started recording podcasts to draw attention to the challenges and opportunities impacting the supply chain as we transition from pandemic to endemic. We intend that this become a regular feature to communicate with our members.
Supply Chain Management for Cell and Gene Therapy
This workstream was commissioned in June and has been working to further refine the draft charter and to test the business benefit premises of the workstream and develop the recruitment deck to enable the recruitment of the right Subject Matter Experts (SMEs) to deliver against the intention of the Charter developed by the Phorum Leadership Team.
SMEs are being recruited and the workstream is moving to the ‘design and development’ of the deliverables that will turn the charter into a tangible deliverables for members to implement to accelerate the development of supply chain management best practice by cell and gene therapy suppliers and biomanufcturers alike.
Supply Chain Quality Management (incorporating the Joint Audit Approach)
The team has redefined it’s scope to include all supply chain quality management processes relevant to the operation of the inbound supply chain e.g., supply change notification, supplier pre-qualification and certification. It also plans to develop the understanding of what processes are able to be harmonized/standardized for the benefit of the operation of the inbound supply chain.
