Trends, challenges and priorities

The COVID-19 pandemic highlighted industry-level weaknesses in the inbound supply chain structure and function and has intensified existing failures that allow demand to outstrip suppliers’ capacity and capability to support industry’s growth.

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

Sort by:

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.

Cell & Gene Therapy

Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

Drug Substance

Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

Fill Finish

Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges.To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here. 

Information Technology

IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum. 

The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 

Regulatory-CMC

BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, filing and review, interactions with Health Authorities, and harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

Supply Chain to Patient

The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

Supply Partner

BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

  • an enhanced robustness and resilience
  • accelerated capability and capacity to effect technology adoption
  • reduced cost of quality, and
  • industry-wide alignment on operational implementation

There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.

Sustainability

The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

Technology Strategy

With a mission to define strategies to accelerate technology transformation and support the adoption of innovative technologies, BioPhorum Technology Strategy evolved from BioPhorum Technology Roadmapping, strives to realize the technology roadmap vision 2.0.

This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

Building on industry feedback to standardize plasmid release specifications

Plasmids release specifications are critical to the manufacture of many cell and gene therapy (CGT) products, but current regulatory... read more

How to predict, optimize and analyze high-concentration biologic therapeutic formulations

Developing high-dose biologic drugs for subcutaneous injection often requires high-concentration formulations. It also needs to optimize... read more

A media fingerprinting toolbox that comes with a host of benefits

Cell culture media raw materials can contain many chemical substances, each with its own properties. While simple substances can be... read more

Why 100% visual inspection does not mean 100% defect detection

There is a common misunderstanding that 100% visual inspection (VI) of biopharmaceutical products should mean 100% detection of defects.... read more

How to bridge the data integration gap between sponsors and contract organizations

Bringing BioPhorum’s unique perspective to continuous manufacturing in biologics

Continuous manufacturing (CM) has been a goal for the pharmaceutical industry for several years. While small molecule drug substances and... read more

Supply Chain to Patient has launched!

Have your outbound supply chain costs increased? Do you want to leverage data and digital technologies more effectively to reduce... read more

Electronic data exchange – the foundation for an efficient, resilient inbound supply chain

The COVID-19 pandemic, geopolitical unrest, and military action across the world have fundamentally disrupted the assumption and practice... read more

How are you improving your environmental sustainability performance?

Climate change and global warming resulting from greenhouse gas emissions are widely recognized as the biggest threats to global health.... read more

Adding value for analytical instrument partners

Analytical instrument vendors have been integral to developing and publishing our technology roadmaps and developing product... read more

Introducing MediPhorum

The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more
BioPhorum Deliverables Report
BioPhorum brings you the latest Deliverables Report, an informative and inspiring consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry user requirements, study results, and roadmaps produced in the last twelve months.
BioPhorum Downloads
Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.
Case Studies
Welcome to the BioPhorum case studies page, where you can learn how our clients have used our service to discover innovative solutions and save money. Here you can read real-life stories of how various organizations have used our unique data-driven approach to streamline their processes and make the most of their resources. Whether you're looking for inspiration or want to learn more about the potential benefits of our service, you'll find it here.
Webinars and podcasts
Welcome to BioPhorum Connect, the podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, this podcast brings you the insights and perspectives of experts from around the world. We'll discuss all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. So, join us on our journey as we explore the world of biopharmaceuticals and learn from the perspectives of those at the forefront of the industry.
Share This