NEWS

Orchestrating the supply of different cell and gene therapies

4 April 2022
Advanced Therapy Medicinal Products
Information Technology
BioPhorum

Cell and gene therapies (CGTs) and their patient-specific delivery of therapeutics are often seen as the future of medicines. However, CGT manufacture is complex and typically involves multiple organizations delivering a treatment. In such complex ecosystems of delivery partners, it is vital to define who does what, and how it is all orchestrated.

A new BioPhorum document contains a set of reference models explaining who needs to be involved in the supply of different types of CGTs and, at a high level, what they do. It can be used by anyone who wishes to better understand the manufacture and delivery of CGTs, particularly how IT systems can provide support.

CGT actors and process maps: who does what in the supply of different cell and gene therapies defines the relevant organizational units (actors) for CGT supply using clear diagrams, prompting readers to identify where those actors sit in their own partner ecosystem. The function of each actor in the supply process is shown in a few simple process blocks.

Using these models will accelerate the analysis and design of IT solutions to support CGT supply by establishing a holistic end-to-end view of the supply process. Also, it highlights the commonalities and differences with other types of products and reveals the key touchpoints between partner organizations that may require systems to be integrated.

Cutting costs and saving time

By adopting the toolkit, IT systems can be developed that will support industry needs. These will cut costs for CGT manufacturers and software vendors while reducing the overall time for CGT treatments. At the same time, it will increase flexibility, regulatory compliance, and integration between systems.

Six common types of CGT are analyzed (e.g., targeted genetic vector and autologous cell therapy), showing how the pattern of actors and process blocks varies by therapy type. Particular attention is paid to the customer-critical path, i.e., the sequence of steps that need to happen within the tight turnaround times of advanced personalized therapies.

The toolkit includes a spreadsheet and presentation that can be adapted to the unique needs of each partner ecosystem. The models can also be extended to cover new modalities as they emerge while still leveraging any common aspects.

It also provides a common language and framework for collaboration that can be used by:

  • Manufacturers of CGT products
  • Contract manufacturing organizations
  • Treatment centers
  • Shipping partners
  • Vendors and developers of IT systems
  • Regulators.

Readers of this document, whether new to the CGT field or more established players, should use the toolkit to think carefully about the needs of everybody involved in the end-to-end CGT process using this common language. The future will have many more supply partnerships and therapy types, and to remain agile industry needs common ways of working.

By identifying and describing the actors, process blocks and customer-critical paths for several CGT modalities, this paper is a small but essential step in giving a common shape to the complexity of CGT delivery. The soon-to-be-published companion document CGT personas and user stories will explain what people need the IT systems to do to support CGT supply.

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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.

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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.

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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.

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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.

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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.

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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.

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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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