Case study

Leveraging the CGT process maps

The context

Current technology for cell and gene therapies (CGTs) is unsuitable for large-scale production. This is partly because there is no common standard for the industrial manufacturing of CGTs nor any common reference frame for designing a company-specific production facility.

To help fill this gap, BioPhorum’s Cell & Gene Therapy Commercialization Workstream has published a set of process maps for cell therapy and gene therapy. These represent example processes, unit operations, and platform technologies being used in CGT manufacturing. They can be used as an educational tool and will accelerate collaboration projects, process improvements, and product commercialization.

Here, Jørgen Magnus, Strategic Program Manager at Bayer’s Cell and Gene Therapy Unit, describes the BioPhorum process map project, which leveraged an internal Bayer engineering study, and how the new maps can benefit companies when they are considering investing in a facility.

The story

“I brought some internal process maps to the team, which then developed them into comprehensive process map documents for cell therapies and gene therapies,” said Magnus adding that the wide expertise of the team was crucial to their development. “The BioPhorum team consisted of experts from different fields who brought their experience to the project. These included specialists in GMP requirements, bio-safety levels, architecture, processing, and cost calculations.”

We used our internal process maps in 2019 when we wanted to build a production facility for bioreactors

Jørgen Magnus, Strategic Program Manager at Bayer’s Cell and Gene Therapy Unit

The outcomes

“At that point, we did not know what future programs we would have or where this facility would be – in the US, Europe or wherever. So our first step was to conduct a feasibility study where we calculated the cost and timeline to build it.

“Of course, we had to design it according to what we thought our requirements would be, i.e., how many patients we would treat, which was around 4,000 patients. At a high level, the results were a projected $100m capital cost and a three-year build time, based on our Berkley, California site.” Magnus said these figures were critical to making an investment decision and allowing a proper engineering study to take place before building the facility.

“As a basis for this type of decision, you need a complete overview of the different processes that you will have. For example, if the equipment you’re buying is specific for one type of expression system or whether you can use it for the different types of processes, and how flexible your facility will be with a certain type of equipment.”

After deciding on the equipment you need, Magnus added that the next step is to design the facility, e.g., the processing floors for the bioreactors, the downstream equipment, filling rooms, buffers, media preparations etc. “This is how the BioPhorum process maps can be used, as the starting point of an engineering study.”


“The maps give you a complete overview of the different types of processes and help you go into more specific design details, e.g., what type of equipment and its scale,” said Magnus. Example process maps include those for cell bank and plasmid preparation for transient transfection in gene therapy, and autologous and viral gene editing in cell therapy.

“They also help users connect the number of patients that need treatment with the size of your equipment and, ultimately, your facility. For example, if you want to treat 4,000 patients per year, the size of the bioreactor is one of the main design criteria for the facility because everything else is sized according to that. In that whole calculation, the process maps are very helpful.”

He suggested that it is hard to quantify the cost savings from using the process maps, other than to say that time is money, and the maps will definitely speed up the early phase of engineering projects.

At the start of a new project, there are always a few months when the team is just trying to understand it. This phase goes much faster when you can put the process maps on the table as they let you understand how a process works without having to do extensive research

Jørgen Magnus, Strategic Program Manager at Bayer’s Cell and Gene Therapy Unit

Lessons learned

Magnus said that the first step should always be to understand the facility design process. “Some people might say they have a piece of land and they want to put a facility on it, so let’s see what we can fit into that building. But this is the wrong way to do a feasibility study. Instead, you should start with what you need the building for. So the question is, how many patients would you like to treat and with what kind of processes?”

He added that you should always start with your core process then design everything around that, e.g., your utilities and other requirements. “Then you go into the facility requirements, cleanroom classification, bio-safety levels, etc. After that, you go to the next layer, which is the building itself. So, you should go from the inside to the outside.”

The process maps now use improved navigation, e.g., clicking on a high-level process box that takes you to a detailed process map. “Looking ahead, I can see that the process maps could be made even better by including more detail on the processing steps and the equipment that we suggest for each one. At the same time, a second version could include more simple presentations to make them easier to read.

“BioPhorum’s CGT process maps can be used for designing a company-specific process and production facility,” said Magnus, “and are a great first step towards industry standardization.”

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.

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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
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