(MTBE)
19
n-Butanol
30
Dimethyl sulfoxide
10
n-Hexane
20
Methylcyclohexane
31
Dimethylacetamide
With accelerating clinical development, streamlining analytical activities without negatively impacting the assessment of product quality becomes essential.
In many cases, no further validation may be needed to apply this method to regulatory starting materials, intermediates, and in-process testing. Using a platform procedure for residual solvents has significantly accelerated process development and reduced validation requirements for introducing new small-molecule compounds to clinic as well as for commercialization.
Six companies shared examples that highlight how platform procedures are developed, applied to products across modalities in development, and assessed for extent of validation needed to demonstrate fitness. The two CE-SDS examples illustrate that multiple approaches are suitable to establish platform analytical procedures for the assessment of the same quality attributes.
Although one example was applied to commercial registration of mRNA analytical procedures, the remaining examples describe use of platform procedures for the clinical development of mAbs and small molecules. However, consistent with ICH Q2(R2), the principles described in these examples can be applied to commercial products beyond the modalities discussed previously.
Each example leveraged a science- and risk-based approach and followed similar approaches to those outlined in the presented flow charts. Extensive prior knowledge is employed in the development of the platform analytical procedure. This consists of knowledge of the modality as well as requirements of the measurement, analytical technique, and procedure parameters. Measurement requirements for the quality attribute(s) can be described in an ATP, which guides technology selection. An evaluation can be performed if the platform analytical procedure meets the performance requirements of the ATP.
ICH Q14 states, “prior product knowledge plays an important role in identifying the appropriate analytical technique. Knowledge of best practices and current state-of-the-art technologies as well as current regulatory expectations contributes to the selection of the most suitable technology for a given purpose. Existing platform analytical procedures (e.g., protein content determination by UV spectroscopy for a protein drug) can be leveraged to evaluate the attributes of a specific product without conducting additional procedure development.” 2 A risk analysis is completed to evaluate if the platform can be applied to a product with or without any modifications, then the extent of validation experiments required can be determined.
There are many benefits to the application of platform analytical procedures, particularly in the commercial environment. With accelerating clinical development, streamlining analytical activities without negatively impacting the assessment of product quality becomes essential. Platform analytical procedures can enable rapid support of new products during development and subsequent commercialization. This also leads to an increased probability for enhanced robustness. They offer operational, compliance, and training advantages for analysts that do not need to learn unique procedure parameters for every test of every product.
Beyond a reduction in validation activities, transfer activities may be streamlined where testing is consolidated in the same commercial testing laboratory. Additionally, platform analytical procedures provide opportunities for automation that can increase throughput. These advantages may lead to greater reliability of the supply chain, providing value to companies, regulators, and patients. Using the same procedure parameters and validation results additionally leads to more rapid completion of registration documents and inspection readiness. This increases efficiency for health authorities during review and inspection where the procedure has previously been registered and implemented.
Once the product and procedure are registered, there are additional benefits throughout the product life cycle. Continuous monitoring of analytical procedures in the commercial environment is a resource-intensive, yet necessary, activity. Continually monitoring a platform across multiple products is more efficient and increases detectability of performance issues requiring mitigation. Management of this knowledge is critical due to the larger amount of data for one procedure and should lead to rapid and effective troubleshooting with any issues that may arise during routine use.
Although there are many benefits to the use of platform analytical procedures, there are challenges moving forward with this approach in commercial registrations. ICH Q2(R2) allows for validation testing to be abbreviated if scientifically justified. However, the extent of studies required to satisfy health authorities from non-ICH members may delay global acceptance of platform procedures and realization of their benefits. Applicants would also need to address documentation concerns, as the validation results would be provided in the dossier of another product. How that information is linked or copied for a new product would be of concern to the applicant.
The analytical procedure control strategy for the platform, including system suitability, and specific control and/or reference materials used to ensure acceptable performance should be considered. Also, the risk analysis for why a platform analytical procedure was applied to the new product and the extent of validation required would need to be communicated. Perhaps the most challenging aspect would be addressing the change management strategy.
The need to change parameters in a platform procedure for one product would require assessment for all other products that use the platform. These concerns may be reason for some applicants to reconsider or delay registering platform procedures. However, the six examples provide an excellent overview of the science- and risk-based approach that the authors believe are representative of the principles described in ICH Q2(R2) and Q14.
The recent adoption of ICH Q2(R2) and ICH Q14 supports the potential for registering platform analytical procedures. This publication describes six examples that outline varying yet scientifically sound approaches for developing, applying, and implementing platform procedures. Primarily, these examples have been successfully used in clinical development, but the principles can be applied to commercial registration.
Applying platform analytical procedures from one product to another has many benefits that facilitate efficient pathways to registration. Beyond registration, a more streamlined path for postapproval changes is important for the life cycle management of the product. With increasing pressures of cost, speed to market, and product quality, the use of analytical procedure platforms is one aspect of a science- and risk-based strategy for product commercialization that will ultimately benefit patients today.
The authors would like to acknowledge the ISPE Product Quality Lifecycle Implementation (PQLI)® Analytical Methods technical team for its contributions to the subject matter discussed in this paper, and David Michels, Anjana Patel, and Matt Sampson for their support with manuscript preparation and review of the publication.
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In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry: Process Validation: General Principles and Practices.” 1 The document incorporated principles from...
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Inertial motion capture-driven digital human for ergonomic validation: a case study of core drilling.
2. digital human model generation, 2.1. establishment of three-dimensional virtual human model, 2.2. motion capture device-driven generation of a digital human, 3. evaluation of human comfortability, 3.1. calculation of joint angle in the human upper limb, 3.2. calculation of upper extremity joint moments, 4. experiment, 4.1. data acquisition, 4.2. calculation of upper extremity joint angles and torques, 4.3. assessment criteria, 4.4. analysis of visible and reachable domains, 5. discussion, 6. conclusions, author contributions, institutional review board statement, informed consent statement, data availability statement, conflicts of interest.
Click here to enlarge figure
Anthropometry Parameters/Human of the 95th Percentile (cm) | ||||||||
---|---|---|---|---|---|---|---|---|
Stature | Weight | Head Length | Acromion Height | Biacromial Breadth | Arm Length | Elbow Span | Buttock-Popliteal Length | Thigh Clearance |
177.5 | 75.0 | 19.8 | 147.1 | 39.7 | 79.9 | 135.0 | 49.0 | 16.2 |
Position Data of Each Node at the Same Time | Random Sampling Node Number | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | |||
Operating rocker | Left Hand | x | −0.124 | −0.122 | −0.118 | −0.112 | −0.108 | −0.103 | −0.098 | −0.093 | −0.090 | −0.089 |
y | 0.843 | 0.847 | 0.854 | 0.864 | 0.873 | 0.884 | 0.896 | 0.910 | 0.925 | 0.938 | ||
z | 0.194 | 0.192 | 0.191 | 0.189 | 0.188 | 0.186 | 0.187 | 0.189 | 0.193 | 0.199 | ||
Left Lower Arm | x | −0.126 | −0.123 | −0.119 | −0.114 | −0.110 | −0.105 | −0.100 | −0.095 | −0.092 | −0.091 | |
y | 0.839 | 0.843 | 0.849 | 0.859 | 0.867 | 0.878 | 0.890 | 0.904 | 0.919 | 0.931 | ||
z | 0.188 | 0.186 | 0.184 | 0.183 | 0.182 | 0.181 | 0.181 | 0.184 | 0.189 | 0.194 | ||
Left Upper Arm | x | −0.292 | −0.292 | −0.292 | −0.293 | −0.294 | −0.295 | −0.297 | −0.299 | −0.301 | −0.303 | |
y | 0.931 | 0.930 | 0.930 | 0.929 | 0.930 | 0.930 | 0.931 | 0.933 | 0.935 | 0.938 | ||
z | 0.011 | 0.010 | 0.009 | 0.009 | 0.010 | 0.013 | 0.018 | 0.026 | 0.035 | 0.044 | ||
Left Shoulder | x | −0.183 | −0.184 | −0.184 | −0.184 | −0.184 | −0.184 | −0.184 | −0.184 | −0.184 | −0.184 | |
y | 1.175 | 1.174 | 1.173 | 1.173 | 1.173 | 1.172 | 1.172 | 1.172 | 1.172 | 1.172 | ||
z | −0.001 | −0.002 | −0.002 | −0.003 | −0.004 | −0.004 | −0.005 | −0.005 | −0.005 | −0.005 | ||
Twist knob | Left Hand | x | −0.092 | −0.092 | −0.091 | −0.091 | −0.091 | −0.092 | −0.092 | −0.093 | −0.093 | −0.093 |
y | 0.836 | 0.836 | 0.837 | 0.837 | 0.838 | 0.836 | 0.839 | 0.839 | 0.839 | 0.840 | ||
z | 0.034 | 0.034 | 0.038 | 0.039 | 0.041 | 0.042 | 0.043 | 0.044 | 0.045 | 0.045 | ||
Left Lower Arm | x | −0.092 | −0.092 | −0.092 | −0.092 | −0.092 | −0.092 | −0.092 | −0.092 | −0.092 | −0.093 | |
y | 0.831 | 0.831 | 0.831 | 0.832 | 0.832 | 0.833 | 0.833 | 0.833 | 0.834 | 0.834 | ||
z | 0.028 | 0.028 | 0.032 | 0.033 | 0.035 | 0.036 | 0.037 | 0.038 | 0.039 | 0.040 | ||
Left Upper Arm | x | −0.231 | −0.231 | −0.230 | −0.230 | −0.229 | −0.229 | −0.228 | −0.228 | −0.228 | −0.229 | |
y | 0.929 | 0.929 | 0.928 | 0.927 | 0.927 | 0.927 | 0.927 | 0.927 | 0.926 | 0.926 | ||
z | −0.166 | −0.166 | −0.164 | −0.163 | −0.163 | −0.162 | −0.162 | −0.161 | −0.161 | −0.160 | ||
Left Shoulder | x | −0.136 | −0.136 | −0.136 | −0.135 | −0.135 | −0.135 | −0.135 | −0.134 | −0.134 | −0.134 | |
y | 1.166 | 1.166 | 1.166 | 1.166 | 1.166 | 1.165 | 1.165 | 1.165 | 1.165 | 1.165 | ||
z | −0.090 | −0.090 | −0.091 | −0.091 | −0.090 | −0.090 | −0.090 | −0.090 | −0.090 | −0.090 | ||
Push button | Left Hand | x | −0.359 | −0.360 | −0.360 | −0.359 | −0.359 | −0.358 | −0.356 | −0.354 | −0.352 | −0.349 |
y | 0.868 | 0.868 | 0.869 | 0.869 | 0.869 | 0.869 | 0.869 | 0.870 | 0.870 | 0.871 | ||
z | 0.198 | 0.201 | 0.202 | 0.204 | 0.204 | 0.204 | 0.205 | 0.205 | 0.205 | 0.206 | ||
Left Lower Arm | x | −0.357 | −0.357 | −0.358 | −0.357 | −0.356 | −0.355 | −0.353 | −0.351 | −0.349 | −0.347 | |
y | 0.863 | 0.863 | 0.864 | 0.864 | 0.864 | 0.865 | 0.865 | 0.866 | 0.866 | 0.866 | ||
z | 0.192 | 0.194 | 0.196 | 0.197 | 0.198 | 0.198 | 0.198 | 0.198 | 0.198 | 0.199 | ||
Left Upper Arm | x | −0.296 | −0.297 | −0.297 | −0.298 | −0.298 | −0.298 | −0.299 | −0.299 | −0.299 | −0.301 | |
y | 0.974 | 0.975 | 0.976 | 0.976 | 0.977 | 0.977 | 0.976 | 0.975 | 0.975 | 0.975 | ||
z | 0.011 | 0.010 | 0.009 | 0.009 | 0.010 | 0.013 | 0.018 | 0.026 | 0.035 | 0.044 | ||
Left Shoulder | x | −0.128 | −0.128 | −0.128 | −0.129 | −0.129 | −0.129 | −0.130 | −0.130 | −0.130 | −0.131 | |
y | 1.171 | 1.171 | 1.172 | 1.173 | 1.173 | 1.172 | 1.172 | 1.172 | 1.172 | 1.172 | ||
z | −0.097 | −0.097 | −0.097 | −0.096 | −0.096 | −0.095 | −0.095 | −0.096 | −0.094 | −0.094 |
Upper Limb Movement | Joint Parameter | Experimental Data Statistics | ||
---|---|---|---|---|
Average Value | Minimum Value | Maximum Value | ||
Operating rocker | Shoulder angle (°) | 66.04 | 48.01 | 98.91 |
Elbow angle (°) | 86.32 | 67.98 | 113.62 | |
Wrist angle (°) | 31.02 | 22.99 | 43.47 | |
Shoulder torques (N·cm) | 253.39 | 0 | 857.79 | |
Elbow torques (N·cm) | 119.66 | 0 | 483.62 | |
Twist knob | Shoulder angle (°) | 95.46 | 65.79 | 130.06 |
Elbow angle (°) | 108.65 | 82.81 | 133.29 | |
Wrist angle (°) | 78.82 | 58.12 | 104.85 | |
Shoulder torques (N·cm) | 296.78 | 0 | 1108.45 | |
Elbow torques (N·cm) | 189.35 | 0 | 746.83 | |
Push button | Shoulder angle (°) | 66.04 | 48.01 | 98.91 |
Elbow angle (°) | 82.61 | 50.83 | 117.43 | |
Wrist angle (°) | 36.30 | 14.32 | 63.18 | |
Shoulder torques (N·cm) | 213.80 | 0 | 738.64 | |
Elbow torques (N·cm) | 101.33 | 0 | 250.21 |
Joint | Mode of Motion | Limiting Angle | Comfort Zone |
---|---|---|---|
Shoulder joint | Front and rear pendulum | 140°~40° | 40°~90° |
Elbow joint | Bend and stretch | 140°~40° | 80°~110° |
Wrist joint | Wrist flexion and extension | 80°~70° | 10°~30° |
Joint | Upper Limb Movement | ||
---|---|---|---|
Operating Rocker | Twist Knob | Push Button | |
Shoulder joint | 0.782 | 0.758 | 0.800 |
Elbow joint | 0.833 | 0.797 | 0.815 |
Comfort Level | I | II | III | IV | V |
---|---|---|---|---|---|
Comfort index | |||||
Comfort description | Very uncomfortable | Not comfortable | Generally comfortable | More comfortable | Very comfortable |
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Zhao, Q.; Lu, T.; Tao, M.; Cheng, S.; Wen, G. Inertial Motion Capture-Driven Digital Human for Ergonomic Validation: A Case Study of Core Drilling. Sensors 2024 , 24 , 5962. https://doi.org/10.3390/s24185962
Zhao Q, Lu T, Tao M, Cheng S, Wen G. Inertial Motion Capture-Driven Digital Human for Ergonomic Validation: A Case Study of Core Drilling. Sensors . 2024; 24(18):5962. https://doi.org/10.3390/s24185962
Zhao, Quan, Tao Lu, Menglun Tao, Siyi Cheng, and Guojun Wen. 2024. "Inertial Motion Capture-Driven Digital Human for Ergonomic Validation: A Case Study of Core Drilling" Sensors 24, no. 18: 5962. https://doi.org/10.3390/s24185962
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Nature Reviews Bioengineering ( 2024 ) Cite this article
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Stress urinary incontinence (SUI), a frequently underdiagnosed condition that mainly affects women, lacks effective and long-term treatment options. MUVON Therapeutics has developed a tissue-engineered advanced therapy medicinal product for the treatment of SUI, based on autologous cells, which is being tested in a phase II clinical study — a challenging development effort.
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Danforth, K. N. et al. Risk factors for urinary incontinence among middle-aged women. Am. J. Obstet. Gynecol. 194 , 339–345 (2006).
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Patel, U. J., Godecker, A. L., Giles, D. L. & Brown, H. W. Updated prevalence of urinary incontinence in women: 2015–2018 national population-based survey data. Female Pelvic Med. Reconstr. Surg. 28 , 181–187 (2022).
Schmid, F. A. et al. Transurethral injection of autologous muscle precursor cells for treatment of female stress urinary incontinence: a prospective phase I clinical trial. Int. Urogynecology J. 34 , 2197–2206 (2023).
US National Library of Medicine. ClinicalTrials.gov , https://clinicaltrials.gov/study/NCT03439527 (2021).
Iglesias-Lopez, C., Agustí, A., Vallano, A. & Obach, M. Current landscape of clinical development and approval of advanced therapies. Mol. Ther. Methods Clin. Dev. 23 , 606–618 (2021).
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We thank all team members of MUVON Therapeutics for their expertise and personal achievements in each of the topics mentioned, while translating an academic process towards a commercial one. We also thank M. Graf for his input on the literature search and T. Haralampieva, N. Schwarz and J. Hegetschweiler for graphic design. We acknowledge funding and support from Horizon2020 for the phase 1 trial, and Wyss Zurich Translational Center and University of Zurich for the phase 2 study.
Authors and affiliations.
MUVON Therapeutics AG, Zürich, Switzerland
Deana Mohr-Haralampieva, Steve Kappenthuler & Marcus Droege
University of Zurich, Wyss Zurich Translational Center, Zurich, Switzerland
Deana Mohr-Haralampieva
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Correspondence to Deana Mohr-Haralampieva .
Competing interests.
D.M.-H., S.K. and M.D. are involved with the company MUVON Therapeutics AG. This relationship could potentially influence the interpretation and presentation of the research findings discussed in this manuscript.
Related links.
Women are affected twice as often as men, with an estimated 40% of women above the age of 40 experiencing SUI: https://www.swanstudy.org/urinary-incontinence-problematic-for-many-women-over-40-study-finds/
World Federation of Incontinence and Pelvic Problems (WFIPP): https://wfipp.org/
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Mohr-Haralampieva, D., Kappenthuler, S. & Droege, M. Treating stress urinary incontinence by tissue engineering. Nat Rev Bioeng (2024). https://doi.org/10.1038/s44222-024-00246-6
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Learning and Teaching
The Department of Chemical Engineering at University of Bath has run focus groups with students to understand how staff can enhance climate and sustainability teaching provision in their courses. In May 2024, the Equality, Diversity, and Inclusion (ED&I) Committee Chair Dr Hannah Leese and departmental Climate Advocate Dr Sandhya Moise co-organised a consultation session with final-year Chemical Engineering students, one of whom also sits on the ED&I Committee. Participants were drawn from the MEng Chemical Engineering and MEng Environmental Engineering courses. The focus groups prioritised discussion of the links between sustainability and social justice in these disciplinary contexts.
Published on: 16/09/2024 · Last updated on: 16/09/2024
The impetus for the consultation, which aligned climate change, sustainability, and ED&I efforts across the department, stemmed from the recognition that climate change is intricately linked with questions of social justice: climate change disproportionately affects vulnerable and marginalised communities, limiting their access to resources such as clean water, food, energy, and healthcare. As such, engineering solutions must be inclusive and avoid exacerbating inequalities. Future engineers must be equipped with the skills and tools to evaluate climate change solutions through a lens of equality, diversity, and inclusivity. How, then, can engineering curricula respond to this challenge?
The student focus groups identified key areas that will feed into future curriculum design in the department:
Student feedback on the session was very positive: “I found the EDI-Sustainability focus group to be valuable, as it provided a safe space to voice our views and experiences, and to reassure us that diverse student perceptions and viewpoints are heard and valued. My main takeaways were a deeper understanding of existing EDI and sustainability initiatives in the department, and how these aspects are currently recognised and embedded into the Chemical Engineering curriculum. I appreciated the opportunity to give constructive feedback on how this can be built upon, with the understanding this can be used for continuous improvement for future cohorts.”
Following the focus groups, the Department is introducing further mechanisms to ensure that students are at the heart of its initiative to align climate and sustainability education with ED&I and social justice perspectives. The Department of Chemical Engineering will continue working alongside the Chemical Engineering Student Group (CESG) membership to enable students to drive the sustainability agenda forward within the department. Dr Moise runs a ‘Climate change and Chemical Engineering’ talk in Freshers Week to foreground this aspect of the curriculum and to signpost the CESG. The CESG President is also regularly invited to appropriate lectures across year groups to remind students of opportunities for engagement. In parallel, the ED&I Committee Chair attends all Head of Department Welcome Talks for Freshers and returning students and is working closely with teaching staff across the Department to support students to reflect on inclusive design, and ED&I experiences. Provision in this area is driven by a broad belief that both ED&I perspectives and climate and sustainability education necessitate an engagement with students’ broader lived experience, an insight borne out by the focus groups.
Do you want to know more about embedding climate and sustainability skills in your teaching? Find guidance and resources for embedding sustainability in the curriculum on the Teaching Hub, or learn more about Climate Action Education at Bath.
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Case studies are more than just success stories.They are powerful tools that demonstrate the practical value of your product or service. Case studies help attract attention to your products, b. We've put together 15 real-life case study examples to inspire you. These examples cover a variety of industries and formats, plus templates to ...
In fact, studies have shown that product dissection can help students relate classroom material to real-life engineering problems [21], help engage first year engineering students in learning [22 ...
L. Brownsword, and P. Clements, "A Case Study in Successful Product Line Development," Carnegie Mellon University, Software Engineering Institute's Digital Library.Software Engineering Institute, Technical Report CMU/SEI-96-TR-016, 1-Oct-1996 [Online].
Why it's exemplary: Real-world engineering decision making involves multiple actors and, for each, ethical considerations may arise at multiple levels—personal, professional, societal, or global.Our program of case studies and educational materials is exemplary in its interdisciplinary foundation, created collectively by engineers, policy experts, business professionals, and ethicists to ...
The latest edition in the gold standard of project management case study collections As a critical part of any successful, competitive business, project management sits at the intersection of several functional areas. And in the newly revised Sixth Edition of Project Management Case Studies , world-renowned project management professional Dr. Harold Kerzner delivers practical and in-depth ...
This case study outlines how the Department of Electronic and Electrical Engineering at University of Bath redesigned their core undergraduate curriculum to offer students practical skills related to climate and sustainability. It offers practical insights into how these skills can be embedded in engineering degrees.
The primary objective of this case is to introduce the notion of why and how businesses are transforming by leveraging digital information technologies. Additionally, the case reinforces concepts typically covered in today's introductory information technology and systems (ITS) courses. The secondary objective of the case is to illustrate the importance of integrating information technology ...
Background. The following case study illustrates how the Predicted Crash Frequency with CMF Adjustment method has been used to explicitly consider the safety impacts of opportunities during the Value Engineering (VE) process. Specifically, it focuses on the quantification of safety in the evaluation phase when safety is a project factor and crash frequency is the related performance measure.
Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how ...
In the evolving realm of ergonomics, there is a growing demand for enhanced comfortability, visibility, and accessibility in the operation of engineering machinery. This study introduces an innovative approach to assess the ergonomics of a driller's cabin by utilizing a digital human. Through the utilization of inertial motion capture sensors, the method enables the operation of a virtual ...
At the University of Zurich, over a decade of pre-clinical and proof-of-concept studies led to Swiss authorities approving a phase I clinical trial for this tissue-engineering therapy for female ...
Case study: Student focus groups in Chemical Engineering map path to enhanced climate and sustainability teaching in undergraduate curriculum. The Department of Chemical Engineering at University of Bath has run focus groups with students to understand how staff can enhance climate and sustainability teaching provision in their courses.