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Cell and Gene Therapy (CGT), delivered at a very crucial time during the treatment for target diseases, offers patients hope for a cure or at least the reduction of further harm caused by the disease. In the last few years, several advanced therapy options have emerged out of research labs to enter the development and production phase while many more continue to be in trial.

More than 1,000 CGT clinical trials are being conducted by about 900 companies globally, and at least 10 to 20 new advanced therapies are expected to start emerging every year from 2025. As a result, the global CGT market is expected to be around USD 13.37 billion by 2025, growing at a compound annual growth rate of nearly 36% between 2019 and 2025.

However, as it is often seen with innovative and disruptive technology, CGT too creates many challenges for the developers during various stages of the product life cycle. These include:

  • Enabling patient access
  • Managing manufacturing and supply chain operations
  • Compliance with the increasingly complex regulatory requirements
  • The need for alternate business models to overcome these challenges

Next Gen AI

An Integrated Ecosystem

Timely delivery of the therapy to the patient plays a crucial role in advanced therapies. From the time of extraction of the starting material to the development and delivery of the therapy, the process needs much care and attention. It involves multiple parties and an integrated ecosystem that can make the process smoother and improve service levels.

It requires well-orchestrated harmony between manufacturing and supply chain for resource optimization and capacity management.

Some of the common challenges CGT developers face in the absence of an integrated system include:

  • Risky and expensive manufacturing due to the very niche nature of the products
  • Being a personalized therapy, it is difficult to predict demand and plan for capacity
  • Administration of the drug requires specialized skills, advanced administration protocols, and specialized clinical resources for managing and monitoring the patients (both long-term and short-term)
  • Recovering costs for these expensive, single-dose treatments with long-term clinical value can pose a challenge

According to EY, there are three areas where CGT manufacturers need to focus on to overcome these challenges. This is regardless of whether they develop autologous treatments for a single patient or allogeneic therapies for several, unrelated patients. The focus areas include:

  • Removing the friction points in the supply chain
  • Streamlining customized manufacturing
  • Creating cost-effective therapies

EY conducted a qualitative survey of CGT supply chain representatives to identify their pain points. The findings reveal:

  • A fragmented supply chain
  • Lack of standardization
  • Labor-intensive process
  • Siloed systems due to the use of multiple, incompatible software
  • Lack of real-time visibility into the patient and therapy journey

EY’s survey findings also reiterate the need for an integrated system that connects the workflows of the various stakeholders such as manufacturers, suppliers, and logistics providers. To deliver the right treatment at the right time and place, a unified digital platform that promotes better collaboration while managing the chain of identity and chain of custody can improve cost-efficiency and enable high-volume distribution. As demand increases and organizations seek to scale up, the heavy dependence on manual processes and skilled laborers will be a limiting factor. Greater automation and streamlined processes will be key to enabling growth. By collaborating, manufacturers will be able to leverage the introduction of new therapies, optimize resources, and increase the efficiency of their processes.

Strategic Partnerships for Timely Delivery of CGT

To overcome the gap in knowledge and service in advanced therapies, end-to-end management of the supply chain is critical. Due to the urgent nature of the therapy requirement, manufacturers need access to readily available expertise and services to prevent any delays in the development and delivery of the therapy. Increasingly they are seeking strategic partners with the right experience, innovation, infrastructure, and investment, with manufacturing and high-performing supply chain capabilities.

By improving the knowledge of the workflow, risks in the supply chain can be minimized. But, it is equally important to finding a partner whose services and expertise meet the requirements of the manufacturing company. Service areas range from packaging, storage, to the distribution of supplies. This in itself has become a challenge due to the inability to find partners with the requisite experience and expertise. The other challenges are

  • Identifying a single vendor with manufacturing and supply chain capabilities
  • Finding a vendor who can handle cell and gene therapies
  • Partnering with a vendor who can predict future clinical supply needs to better plan manufacturing schedules

The partner must understand the sensitive nature of the materials being used and know how to handle and transport them. They must know regulatory requirements and ensure compliance as well as provide the necessary documentation.

Administration, monitoring, recording observations post-administration of the therapy are also critical aspects that can inform future therapies. This makes a long-term commitment to the therapy essential.

ComplianceQuest – A Unified Platform for Integrated CGT Workflows

Built on Salesforce.com, the ComplianceQuest EQMS provides a unified platform to integrate workflows across organizations and locations. It facilitates collaboration between remote teams and provides visibility and traceability across processes.

ComplianceQuest’s various solutions are aimed at enhancing product and process quality and ensuring patient safety.

Aligned to all key regulations governing the life sciences and pharma industries, it facilitates compliance with the various regulatory requirements.

Some of its key modules that can help the various stakeholders in the CGT manufacturing and supply chain to deliver therapies in a timely manner without compromising on quality include:

Supplier Management – From onboarding to training, tracking performance, it can streamline your supply chain output. It can help improve supplier performance by integrating quality, safety, performance management while reducing risk and cost.

Document Management – Manage the entire document lifecycle at scale, gain complete visibility and access a single source of truth across all locations for more effective decision making.

Nonconformance – Automated, data-driven process to identify and manage nonconformance of products and processes to lower the Cost of Quality (CoQ) due to internal failures.

Risk Management – Maintain a centralized repository of identified risks at the project, department, or company level, prioritize based on criticality, and drive strategic decisions. The solution is aligned with the latest standards to help accelerate assessments, identify and analyze risk trends and drive risk mitigation activities.

Change Management – Establish and follow best practice workflows for change management from initiation and review/approval through to execution tracking, verification, and closure.

The solution also enables CAPA and RCA to help you identify the source of problems and address them for long-term resolution.

Complaint handling, equipment management, auditing and inspection are some of the other modules that can help CGT manufacturers and suppliers to automate their workflows end-to-end and deliver therapies on time.

To know more about how ComplianceQuest can help you integrate your manufacturing and supply chain workflows, contact us now: https://www.compliancequest.com/contact-us/

Visit www.compliancequest.com to learn more about our solutions.

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