Overcoming Industry Obstacles for Cell and Gene Therapy Development

Overcoming Industry Obstacles for Cell and Gene Therapy Development

In the rapidly advancing world of cell and gene therapy (CGT) development, finding the proper solution to overcome common industry obstacles is a challenge that can impact entire production timelines. Time is of the essence in the specialized workflow of turning patient cells into an advanced therapy, so solving these challenges is vital to ensure that patient lives aren't put at risk.
As the premier provider of supply chain management solutions for the cell and gene therapy space, Cryoport Systems' platform of services is specifically designed to support the research and development of these specialized therapies. Here are three pertinent obstacles facing the industry and our solutions that work to overcome them.

Obstacle: Lack of Infrastructure and Knowledge Required to Support Ultra-cold Storage Capabilities

According to an article in Drug Discovery Today, one of the most challenging aspects facing the CGT space is the lack of available infrastructure and knowledge to properly store these irreplaceable therapies. The survey included 23 senior clinical supply chain leaders from some of the largest global pharma companies who had all together conducted 5,893 clinical CGT trials within the last five years. This survey found that "less than 5% of the 5,893 studies required conditioning between -70°C and -20°C and less than 2.5% necessitated conditioning below -70°C."(1) Additionally, they reported that only 17% of their survey participants felt "fairly confident" in their organization's cold chain capabilities. Drug Discovery Today theorized that these numbers reflect researchers' overall reluctance to conduct CGT research based on the lack of proper infrastructure. Rob Jones, Cryoport Systems' Vice President of Global Bioservices, echoed this sentiment stating, "The lack of proper infrastructure or facilities to house sensitive materials is becoming more of an issue. Research in this space can't occur without it, but very few organizations can support the controlled temperature storage in-house that manufacturing these therapies requires."

Solution: Outsourcing Controlled Temperature Storage to the Experts

Cryoport Systems' precision-controlled temperature storage solutions were developed by industry experts and provide the support required to centralize and store client research collections, biologic specimens, clinical trial materials, and commercial therapies while adhering to the proper compliance protocols. Our storage capabilities range from controlled room temperature (15°C to 25°C) all the way down to cryogenic (< -150°C). All storage units are continuously monitored with our state-of-the-art cloud-based temperature monitoring system, and our highly trained team is on-call 24/7/365 to respond to any alarm. This outsourced support of GMP-compliant biobanking and controlled temperature biostorage supports researchers' life-saving work in the CGT sector, allowing clients to leverage our state-of-the-art storage facilities and knowledgeable team of personnel.

Obstacle: Establishing an Unfailing Closed-loop Supply Chain

CGT development begins and ends at the same place - the patient's bedside. This closed-loop supply chain requires an unfailing chain of identity and custody to maintain consistent reporting channels for material track and trace. Deloitte reported that to achieve a closed-loop supply chain, organizations need to institute sound technological tracking systems that record the conditions of the therapy throughout the entire supply chain. This includes both precision recording and documentation methods to "maintain visibility into patient specific product batches and infusion schedules."(2)

Solution: Total Visibility & Accountability with Chain of Compliance®

Full traceability throughout the entire supply chain can be achieved with Cryoport Systems' Chain of Compliance® precision process. The Chain of Compliance® establishes complete identification of the equipment and processes used in managing the environmental control of the commodity throughout the supply chain, including identification of equipment performance, requalification history, commodity history, courier handling and performance history, calibration history, and correlation competencies that can link in-field events to equipment performance. This process was developed to meet and uphold ISO 21973:2020 standards across all Cryoport Systems' services and facilities. The Chain of Compliance® provides robust data management to mitigate risk and to better understand variability.

Obstacle: The Ability to Strategically Scale Operations

The inability of organizations to scale their operations drastically affects the CGT industry. Accenture identified a general need for more talent and experience as a prohibiting factor to the scaling of manufacturing capacity through their survey of 200 US-based cross-sector CGT department leaders from companies of all sizes. They found that 96% of the respondents believe that the challenges around recruiting top talent will remain a key limiting factor in the near future.(3) This demonstrates the commonplace skepticism within the CGT industry that operation scaling is not likely or possible without the additional in-house assistance of knowledgeable talent and robust, specialized project support.

Solution: Seamless Scalability with BioServices

Cryoport Systems' BioServices offerings were engineered for scalability with input from industry experts to facilitate seamless growth. Our expert teams in the CGT space will closely collaborate with our clients to develop a strategy to store, receive, distribute, and manage precious biomaterials beginning from the initial stages of raw or starting cellular materials and extending to the delivery of the manufactured therapy to the patient. Our BioServices capabilities were designed to offer supplemental support to our CGT clients so that they could focus more of their efforts on their life-saving research while Cryoport Systems facilitates the logistics of supply chain scaling, which negates the need for additional in-house overhead.

Connect with our team to discover how Cryoport Systems' platform of compliant solutions can help your organization overcome these obstacles as well as additional challenges facing your CGT research and development.

1. Fehm, T., Boehme, P., & Modak, N. (2023, February). The clinical supply of cell and gene therapy drugs: Challenges ahead. Drug Discovery Today. https://www.sciencedirect.com/science/article/abs/pii/S1359644622004147?via%3Dihub
2. Distribution and Supply Chain Models in the Cell & Gene Therapy Landscape. (2021, June). Deloitte. https://www2.deloitte.com/content/dam/Deloitte/be/Documents/be_deloitte_distribution_and_supply_chain_models_in_the_cell_and_gene_therapy_landscape_paper.pdf
3. Accelerating the culture cure. (2022, March 11). Accenture. https://www.accenture.com/us-en/insights/life-sciences/cellandgenetherapy

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