Trends, challenges and priorities

The Covid-19 pandemic has continued to impact the work of BioPhorum Supply Partner in 2021, though the group anticipates that they will be moving from a pandemic to an endemic situation. The team continues to use the lessons they have learned during the early part of the pandemic 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.

Covid-19 pandemic

During the past several months, the biopharmaceutical industry has begun to come to terms with the pandemic, and companies have wanted to restart their projects and manufacturing processes. This jump start in production will greatly impact the supply chain, which will likely be further impacted by ongoing issues with logistics and transportation disruptions, from shipping bottlenecks to limited labor, and even local regional issues like Brexit. The phorum realizes that the industry is dealing with a lack of raw materials of all kinds, which changes from one week to another. Vaccine production will continue in high volumes and newer emerging Covid-19 treatments will also likely exacerbate limited raw materials. The phorum will continue to promote solutions that alleviate these issues, from increasing 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 apaper which is an  Industry proposal for a simplified registration process of complex and innovative raw materials in Europe , that can be used by the industry.

The Phorum also continues to support the growth in capacity from the supply base. Companies are investing in supply expansion and the team recognizes that there are approaches the group can take to help companies achieve these improvements faster, such as a joint audit approach. We encourage companies to make use of the joint audit approach in their normal modes of operation or when there is a new line or facility to qualify to reduce the audit burden and accelerate access of materials to industry.

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.

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Strategic framework

Our member companies want the inbound suuply chain for the biomanufacturing industry to be recognized as one of the best understood and managed global supply chains. As part of their 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 a lot of 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 is developing an approach to be able to use tangible methods to measure performance to ensure that they are increasing value 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 the different types of suppliers throughout the industry, from those involved in raw materials to those that play a role in getting medicine in a container. The team is enthusiastic about these objectives, especially since they resonate with many cooperate objectives. Over the next year, the group will continue to bring subject matter experts together along with the leadership team and communicate their objectives and strategies to higher levels to drive support across the industry. 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 November 2021 to November 2022

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Milestones

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.

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.

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.

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.

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.

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.

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.

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.

 

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.

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.

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