Trends, challenges and priorities

Digital and technology advances create exciting opportunities for the next step-change in performance in biomanufacturing. Using BioPhorum’s technology roadmap, we understand how market trends translate into manufacturing targets around speed, cost, quality, flexibility, and sustainability. IT and digital advances will be crucial to meeting these challenges and achieving these goals. The digital manufacturing facility of the future needs to consider digital and technology advances alongside organizational perspectives, bridging the gap between information and operational technology while maintaining foundational security requirements. All elements need to be considered in terms of the long-term systemic change towards the digital factory vision and the BioPhorum IT collaboration is delivering important aspects of this vision.

Pursuing digital maturity

BioPhorum IT’s Digital Plant Maturity Model (DPMM) allows members to assess the current digital capability in manufacturing of each plant and decide on investment strategies that enable an appropriate digital plant capability across the manufacturing network. Currently our biomanufacturing members are focussed on uplifting and refreshing the model so that it is relevant in current time to the industry.

BioPhorum IT Portfolio

IT for CGT

As Cell and Gene Therapy (CGT) manufacturing develops, there is an opportunity to build a digital approach without the burden of legacy. BioPhorum IT works with the BioPhorum CGT community to understand IT and digital requirements through discussions with process experts, resulting in publications describing a new approach to understanding and discussing the ‘actors’ process maps, ‘personas’ and user stories and capability architecture.

Cyber security

The trend for connectivity and digitization in manufacturing and the supply chain increases the amount and value of data used across all connected devices. These can create security challenges that can have far-reaching effects if not addressed. Cyber security is key to resilient manufacturing. Our Cyber Security workstream is working hard in this area. It is engaging with our member’s cyber security operational experts and chief information security officers to understand, strategically and operationally, what we need to do differently, how quickly and more effectively to respond to these challenges. The work includes a series of papers enabling understanding and a dialog about security issues and the different ways of resolving them, focusing on standard practices and maintenance approaches.

Contract manufacturing

Another trend relates to the increasing use of contract manufacturers and contract laboratories. Biomanufacturers are investing in digital manufacturing but when engaging with their complex ecosystem of contract suppliers, the data flows can be inefficient. We are responding to this trend by investigating how we can improve data flows and what core data standards are needed for those IT and data relationships to be much more efficient. Providing a solution for these issues will offer tremendous value to contract manufacturers and license holders as a single, standard approach will be beneficial for everybody when a product is outsourced for manufacture. Currently, we are exploring these options in the Digital Integration of Sponsor and Contract Organizations (DISCO) Workstream.

Information Technology deliverables November 2021 to November 2022

Sort by:

Filter by workstream


Augmented Reality/Virtual Reality (AR/VR) Applications

Many companies are investing in proof-of-concepts to understand the potential value of AR/VR (often under the umbrella of XR – extended reality), with a variety of use-cases being explored. Examples in user training and process support are common.

The value of AR/VR solutions cannot yet be fully realized in biopharma. For example, some hardware cannot be used in cleanroom/GxP environments. Scaling AR/VR solutions to work in secure and standard ways across all manufacturing facilities is non-trivial. Sometimes, there are shortcomings in product offerings and a common voice of all relevant stakeholders helps to ensure these issues are recognized and addressed.

The industry believes that AR/VR solutions promise much, with strong use cases identified, but without the engagement of internal quality stakeholders, regulators, and an agreed industry voice on the application in GxP, the full potential value will not be realized.

In 2021 the team met with Microsoft global product teams to discuss the HoloLens 2 hardware, and associated MS Guides software. Material prepared for this evolved into a user requirements document for AR/VR hardware and software. Valuable discussions with key suppliers took place, and the requirements are now published.

The team is in the process of writing a risk assessment document to help the industry understand the relevant risk categories to consider purely from the perspective of implementing AR/VR technology. In addition to this a vision paper to describe the framework of how AR/VR technology can support GxP processes where regulatory requirements must be considered is being worked on by the team.
Member company case studies continue to be explored amongst the group.

Cyber Security

The Cyber Education series has published a valued set of documents, setting out approaches to foundation topics such as asset management, patching, resilience, recovery, and third-party security.

More recently the team worked on two sprints. One of these has developed material to support an Incident Response tabletop exercise. This material imagines a cybersecurity scenario that key stakeholders need to address, with additional time-based complexities being added. The exercise can be used to test out the preparedness of technical and business teams to resolve a cyber incident. The template can be used to develop new scenarios too. The material will be published by end 2022. The second sprint has examined the challenges of Vulnerability Management. This information will probably be shared by the end of Q1 2023.

The team recently voted on new sprint topics. The priority is to develop a cyber security maturity assessment and strategy which speaks the language of business and promotes the topic of cybersecurity on the corporate agenda. The second priority is to improve the way we interact with third-party vendors, looking for more standardization and efficiencies across biopharma. The third priority is to work through the challenges of using cloud infrastructure to support operational technology (OT).

The Cyber Security portfolio is regularly reviewed and voted by the workstream SMEs to agree the priority topics.

In 2023 we want to create a space for Chief information security officers (CISOs) to come together to think through important topics related to that key role.

Digital Integration of Sponsor and Contract Organizations

The Digital Integration of Sponsor and Contract Organizations (DISCO) program has grown to 75 representatives of 31 companies, comprising biopharmaceutical sponsors, contract organizations and IT supply partners, working together to bring about a shared vision for digital maturity in integration between organizations.


Between them, the group has shared over 30 case studies and innovations which now form a reference library useful to anyone considering similar projects.

The group consolidated their learning into a vision that will be published in late 2022. This describes the current situation and its problems and the benefits we are seeking from better integration. It lists an industry view of the priorities for integration, which were validated by a survey, with 31 responses from 22 companies. It describes a maturity model for assessing the current state and choosing appropriate targets for the future. The model of alignment in layers cuts through the jargon to focus attention on the areas where new standards will be needed.

Team members now take turns at presenting their company strategy for integration and relevant case studies, showing how the vision is being brought to life and identifying further areas for us to work on.

Future direction

The goal of the program’s ongoing work is to see the vision becoming reality, overcoming obstacles to change, creating frameworks that will make it easier, forging alignment among key players, and initiating progress towards standards.

In 2022-23 some key topics will include cybersecurity, a contribution to the refreshed Digital Plant Maturity Model, and focussed work on a selection of specific integration points such as deviations and certificates of analysis.

Better integration between organizations will make more and better data available faster, giving visibility and allowing processes to be optimized while improving compliance. Manual activities will be reduced, and new partnerships will become easier, allowing the industry to become more agile, and to support the pipeline of advanced and personalized products.

Digital Plant Maturity Model (DPMM)

BioPhorum IT’s DPMM allows members to assess the current digital capability in manufacturing of each plant and decide on investment strategies that enable an appropriate digital plant capability across the manufacturing network. Currently our members are focussed on uplifting and refreshing the model so that it is relevant in current time to the industry.

IT for Cell and Gene Therapies

The IT for Cell and Gene Therapies program has grown to 58 representatives of 20 companies, comprising biopharmaceutical manufacturers, software and equipment vendors, working together to bring about a shared vision for digital maturity in the manufacture of cell and gene therapies.


The vision for digital capabilities for cell and gene therapy, published 2020 is targeted to educate IT professionals in the distinctives of cell and gene therapies, so that they are productive faster and the solutions they create have better foundations, support more products, and are more maintainable.

IT can be simple: using analogies to facilitate collaboration on the IT challenges of supplying cell and gene therapies, published at the end of 2021, provides creative and visual ways to bridge the gap of understanding

Team members now take turns at presenting their company strategy for IT to support CGTs and relevant case studies, showing how the vision is being brought to life and identifying further areas for us to work on.


The team has run a number of sprints to create publications and a set of tools to accelerate the analysis and design of systems to support CGTs.

CGT actors and process maps: Who does what in the supply of different cell and gene therapies (April 2022) describes how the required digital capabilities vary according to the type of cell and gene therapy platform.

CGT personas and user stories: What people need the systems to do to support the supply of cell and gene therapies (April 2022) provides a toolkit to support analysis and system design: not just what is needed, but why.

Future direction

The goal of the program’s ongoing work is to provide consistent approaches with reusable methodologies or frameworks that will help speed up the development of IT architecture to support new modalities. In 2022-23 some key topics will include traceability, composable architecture, release, next generation sequencing (NGS) and integration of bench-scale equipment for CGTs.

All of this will accelerate industry alignment and make partnership easier, there’ll be fewer dead-end, unmaintainable, unscalable solutions; more equipment integration and informatics alignment, and better IT foundations to support the future range of CGT products. Ultimately there’ll be fewer deviations and improved patient outcomes.

Lab of the Future

The team has presented the Lab of the Future Manifesto: Digital technology-based capabilities for the quality control (QC) lab of the future (published September 2020), at TRMx Conference (December 2020), BPI East Conference (September 2021) and Biovia User Conference (September 2021).

Biomanufacturer strategies and case studies

The biomanufacturers and contract and development manufacturing organizations (CDMOs) in the team take turns at presenting their company’s lab of the future strategy and relevant case studies, showing how the manifesto is being brought to life.

Laboratory equipment and software roadmaps

The team has a process for contacting key vendors of laboratory equipment and software and invites them to present and discuss how their roadmaps support the manifesto vision. The first ten engagements revealed committed plans and potential items for their roadmaps, with an invitation to the team to help the vendors prioritize those future pieces of work via comments and surveys.

Lab instrument integration

The second sprint during 2021 delivered an industry paper on the benefits of progressively sophisticated lab instrument integration. Surveys of biomanufacturers, instrument vendors and lab informatics system suppliers will be used to establish the feasibility of defining an industry position on how to approach lab instrument integration. The sub-team has strong connections with industry initiatives in this area and is influencing the development of standards.

Data integrity

In July 2020, 15 companies reviewed the significant progress they made on improving data integrity in laboratories in recent years but noted the increased expectations of inspectors. They also identified challenges that have not yet been well defined, such as data integrity in the cloud and data from third parties in the supply chain. These unique challenges of data integrity in labs (in the form of a best practices guide) were published by BioPhorum in 2022.

Future direction

The team continues discussions with key laboratory equipment and software vendors about their roadmaps towards the lab of the future. A prioritized set of manifesto topics is the focus for definition and scoping exercises, which usually include a compare and share from most of the participating companies. Based on the topic scoping exercise, periodic prioritization surveys are used to establish new sub-team sprints to create deliverable outputs. Sprints taking place include Standardization of Quality Control (QC) Data Architecture and Infrastructure, as well as innovation topics such as Augmented Reality (AR), Robotics and Voice Enablement to help work towards “assisted scientist” ways of working in the QC laboratories.

MES of the Future

Member companies are investing a lot of resources rolling out or upgrading MES (manufacturing execution system) systems at their production sites. This workstream is exploring what needs to be different for future manufacturing operations, considering different options, user requirements and future industry needs.

A survey has been completed to create a baseline of current approaches, challenges and identify collaboration scope. BioPhorum IT biomanufacturing leaders reviewed the workstream proposal in June 2021 and agreed with the proposed charter and next steps. In January 2022, the workstream published the MES of the future Manifesto. The manifesto clarifies industry objectives and the focus for 2023 will be detailed industry/supply partner discussions on solutions to overcome existing challenges and limitations.

Alongside delivery of the manifesto solutions, the group will continue to share case studies and complete benchmark activity for specific topics of interest.

Smart Maintenance

Companies are looking for better ways to reduce the overall costs of maintenance and energy consumption while reducing downtime and therefore increasing production capacity and safety. The Smart Maintenance Workstream aims to provide practical tools to remove the mystery from smart maintenance and help make it a reality.

This workstream has written an Architecture Blueprint for Smart Maintenance which is due for publication by the end of 2022. It is regarded as an intermediate level of architecture for smart maintenance and constitutes the first in a series of architecture blueprints helping manufacturers to climb the scale of digital maturity toward a fully connected plant. The team continues to share its experiences of implementing smart maintenance solutions, these case studies bring to life the guidance detailed in the architecture blueprint and will be included as appendices.

A scale of smart maintenance has been developed that is an overlay for the Digital Plant Maturity Model (DPMM).

Internal documents related to a template business case, maintenance charter, procurement checklists and retrofit guidance have been developed or are in development.

Future work planned will develop a manifesto of requirements to share with the industry and its partners. This will set out a vision for smart maintenance with suggested areas for standards and a common presentation of asset health and maintenance data, regardless of asset provider.

External collaborations

BioPhorum IT also entered into a partnership with MxD The Digital Manufacturing and Cybersecurity Institute and IAAE International Academy of Automation Engineering who were awarded funding from the FDA Office of Counterterrorism and Emerging Threats in order to identify the barriers and benefits to adoption of smart manufacturing technology in the medical product manufacturing industry. MxD and IAAE utilized the BioPhorum DPMM tool to serve as the foundation for non-internal surveys and interviews conducted during this FDA funded research.

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. 


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.


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