Case study

CGT environmental health and safety


The rapidly expanding field of cell and gene therapies (CGT) could revolutionize curative treatments. Regulatory guidance has been developed to address manufacturing guidelines and CMC specifications for CGT drug products, but occupational health and safety guidelines for manufacturing CGT products have been lacking. For example, there is no ‘universal’ toxicological or potent compound classification or risk assessment scheme for CGT manufacturing processes.

This is why BioPhorum’s CGT environmental health and safety (EHS) and biosafety team was created to bring together biopharmaceutical industry leaders. It aims to develop best practices for personal and environmental safety when conducting CGT research or clinical and commercial manufacturing.

One of the team’s outputs is an article called Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing, which was published in Applied Biosafety: Journal of ABSA International.

The article aims to identify best practices, improve risk controls, and help regulatory agencies develop guidance for environmental and biosafety risk assessment for commercial-scale CGT manufacturing. It includes a risk assessment template highlighting the complexity of commercial-scale manufacturing, the areas to assess, the potential questions to ask, and which other parties may input to the risk assessment.

We spoke to two subject matter experts about the article and risk template and how they have used them in their work.

Summarize the landscape of this area

“EHS is a pretty well established discipline in our industry,” said Simon Godwin, Head of Gene Therapy Technical Operations at Sanofi and one of the authors of the article. “But with these new cell and gene therapy modalities, there are unique challenges in establishing EHS systems that provide the appropriate level of control for the operator, facility, and environments. The challenge is associated with the use of human origin materials in manufacturing (e.g., cell lines) where the biosafety risk profile is case-by-case and is impacted by sourcing, testing, and control of manufacturing.”

He added, “There is also a very diverse portfolio of genetic medicines and delivery platforms all intended to provide persistent and enduring therapeutic benefit, to which the long-term safety is yet to be realized. To this end, the HSE challenges for such dynamic and diverse biological entities cannot be standardized and managed under a universal safety data sheet. As such, it requires a directed biosafety risk assessment tool that enables the site to establish its own safety practices commensurate to the risk profile of its products and processes.”

Godwin explained that, like many other organizations, Sanofi had been challenged to find a balance between the corporate need to move fast and be more flexible, against having more safety, control, containment, and established practices.

This is why working with BioPhorum has been useful as the article and template help us calibrate as an industry and work together to establish best practices based on our combined and shared experiences.

Simon Godwin, Head of Gene Therapy Technical Operations at Sanofi

How did you use the BioPhorum article and template?

Ashley Holland, a safety specialist for Trinity Consultants supporting AstraZeneca Gaithersburg SHE, said its team used the template as a guide while designing its cell therapy lab. “We had a good idea of which projects would be assigned to the lab, and the template helped us ask questions about these projects and the hazards they presented. From there, we were able to update the lab’s design with additional control measures.”

She added that a concern during the design process was whether there were any ‘open’ steps. However, working with the scientists, the team identified the full process and where there was a potential for open steps. Section 4 ‘Process operations and control’ of the template fed into the questions asked by the team.

“At the time, the design phase was a fluid process,” Holland said. “So Section 6 ‘Facilities, equipment and utilities’ was a useful guide. When we met with the team, I asked similar questions about operating space, bearing in mind how materials would be transported. Section 10.0 ‘Storage, shipping and distribution’ was helpful in this step.”

Her team found Sections 6 through 12 ‘Emergency response’ were the most helpful in the design phase because they covered each aspect of the actual operation.

“While Sanofi already has an established EHS process,” said Godwin, “the BioPhorum template helped us ratify what we were doing. And because it was published in a reputable journal, it gave the whole thing more kudos.”

How did you apply the BioPhorum recommendations?

“During the design phase, we used the template as guidance and consulted with the site’s biosafety expert, Kimberly DiGiandomenico – Director SHE-Research & Animal Safety and an author of the Applied Biosafety article,” explained Holland. “At the time, we only used the template. After that, however, we adopted some BioPhorum recommendations, such as those on employee gowning and PPE, sanitization via vapor phase hydrogen peroxide (VHP), facility design with ballroom and ‘batch-dedicated’ rooms, and employee training.”

What lessons did you learn from going through this process?

“My overall takeaway from this process is that it is good to ask these questions during the design phase,” suggested Holland. “That’s when we have the most opportunity to make changes and plan ahead for topics such as those on training and admin controls. It’s also critical to consider future projects coming to the facility, not just what is scheduled. For us, projects in the pipeline have the opportunity to be moved to the facility, so asking whether the design is fit for future projects is important to keep in mind.”

Godwin said it was a little early for him to discuss lessons learned from using the template. “But I imagine that in a year or so, we’ll be able to compare how we applied the template in our businesses, how we interpreted the questions, whether we looked at things in the same way, etc. Reviewing our experiences might lead to greater harmonization.”

He added that documents like the template are always ‘translated’, so the correct use of language was crucial. “We might use British English or American English – it’s still English, but we interpret words differently. So how we use and translate the template might depend on how we understand and manage the risks. We’re still learning, so those future conversations will be really important.”

What are the benefits of being part of BioPhorum?

“For me, it’s taking a novel and complex situation and pulling together a diverse community of people with the same mindset and goal of establishing a common way of working,” said Godwin. “The template allows industry to have a great dialog, which might lead to new regulations, systems, or standards that could be applied more broadly across the industry rather than just in our own companies.”

He said that this community approach to improving our industry and the safety of our staff is what BioPhorum brings to the table. “It lets me go back to my company and look at our systems and say, ‘They’re not good enough’, or ‘Yes, we’re doing a good job’. Of course, we can’t prevent all accidents, but if one does happen, we know that we’ve done everything possible to make it the safest system available.

“As we adapt to these new modalities, these conversations help me ask, are we on the right path? Are we thinking about this the right way? So one of the main things to come out of the risk assessment is the team’s wider conversation. That’s where lessons are being learned, as it helps us ask where we’re aligned with each other and where we’re not. That’s the power of BioPhorum.”

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

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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

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