IT for Cell and Gene Therapies

With many new cell and gene therapies becoming approved for commercial use each year, the challenge of manufacturing consistently, cost-effectively and in tight timescales has increased. Complex manual processes demand immersive training, and digital assist technologies in the clean room. A new range of digital capabilities is needed to trace cells from vein to vein, automate processes, integrate and digitize testing, secure personal data, eliminate delays, and predictively adapt the process to variability in the starting cells and clinical harvesting processes. As they plan the way forward, biomanufacturers must set the right foundations by catching up with best practices in digital manufacturing, supporting personnel with virtual and augmented reality, and eventually moving towards predictive and adaptive processes.

Complex processes

The IT for Cell and Gene Therapies program is a collaboration between leading 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.

With many new cell and gene therapies becoming approved for commercial use each year, the challenge of manufacturing consistently, cost-effectively and in tight timescales has increased. Complex manual processes demand immersive training, and digital assist technologies in the clean room. A new range of digital capabilities is needed to trace cells from vein to vein, automate processes, integrate and digitize testing, secure personal data, eliminate delays, and predictively adapt the process to variability in the starting cells and clinical harvesting processes. As they plan the way forward, biomanufacturers must set the right foundations by catching up with best practices in digital manufacturing, support personnel with virtual and augmented reality, and eventually move towards predictive and adaptive processes. The IT for cell and gene therapy program is creating references and tools to help address some of those issues.

Consistent approaches

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.

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.

IT for Cell and Gene Therapies deliverables

DeliverableDateDetailsDownload

User stories for IT to support cell and gene therapies

31 July, 2023Webinar

Standardizing traceability of personalized cell and gene therapies

27 July, 2023Webinar

Standardizing traceability of personalized cell and gene therapies

24 April, 2023
2.14 MB
368 downloads

CGT personas and user stories

14 April, 2022
4.38 MB
334 downloads

CGT actors and process maps: Who does what in the supply of different cell and gene therapies

1 April, 2022
3.30 MB
410 downloads

IT can be simple: Using analogies to facilitate collaboration on the IT challenges of supplying cell and gene therapies

10 December, 2021
34.10 MB
291 downloads

IT for CGT: Digital capabilities for cell and gene therapy

11 September, 2020
231.87 KB
862 downloads

More related workstreams

Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

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An industry perspective on understanding AAV capsid content variants
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An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
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The Drug Substance 2.0 Strategic Value Framework
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Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

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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.

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Bioreactivity testing in single-use system biomanufacturing
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Bioreactivity testing in single-use system biomanufacturing
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Digital Plant Maturity Model 3.0
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Bioreactivity testing in single-use system biomanufacturing