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Overcoming obstacles as advanced therapies continue to evolve in Europe

Cryoport: overcoming obstacles in advanced therapies development in Europe

In Europe’s evolving biopharmaceutical landscape, the rapid expansion of advanced therapies like cell and gene therapies (CGT) is reshaping the industry. These treatments have the potential to revolutionize healthcare and enhance patient outcomes, underscoring the urgency of their development. Navigating obstacles in CGT development is paramount to ensuring progress, necessitating meticulous management of specialized workflows, and stringent regulations across the supply chain.

Partnering with experienced supply chain leaders accelerates the journey of emerging advanced therapies from development to commercialization. With a comprehensive suite of services tailored to support CGT research and development, Cryoport Systems is expanding its presence in Europe to meet escalating market demands. As demand surges, overcoming challenges becomes pivotal, highlighting the imperative of strategic collaborations with industry-leading partners as the CGT market continues to grow at an unprecedented pace.

Table of contents

    Overcoming a lack of infrastructure and knowledge for temperature controlled storage

    A significant challenge lies in the insufficient infrastructure and knowledge for properly storing invaluable therapies like CGTs. Surprisingly, only a small fraction of studies—less than 5%—require storage between -70°C and -20°C, with even fewer (less than 2.5%) needing storage below -70°C. Moreover, in a recent survey performed by Drug Discovery Today, a mere 17% of surveyed participants expressed confidence in their organization’s cold chain capabilities. These statistics underscore researchers’ hesitance to engage in CGT research due to inadequate infrastructure.

    Rob Jones, Vice President of Global BioServices at Cryoport Systems, echoed this concern, emphasizing the critical need for suitable facilities to house these sensitive materials. He noted the growing challenge of securing controlled temperature storage, essential for manufacturing these therapies, as few organizations possess the requisite capabilities in-house.

    The right partnership will bolster the lifesaving endeavors of researchers in the CGT sector by offering outsourced support for GMP-compliant biobanking and controlled-temperature biostorage. Clients benefit from outsourced, state-of-the-art storage facilities and the expertise of knowledgeable personnel without needing to take on the financial and regulatory burden of building these capabilities in-house.

    Cryoport Systems’ cutting-edge precision-controlled temperature storage solutions are crafted by industry experts and encompass a critical aspect of their organization’s growing footprint in Europe. These solutions cater to the centralized storage needs of client research collections, biologic specimens, clinical trial materials, and commercial therapies all while adhering to stringent compliance protocols. With storage capabilities spanning from controlled room temperature (15°C to 25°C) to cryogenic temperatures (< -150°C), biostorage facilities provide unparalleled versatility. Continuous monitoring via advanced cloud-based temperature monitoring systems is critical to ensure the integrity of stored materials with an expert team available round-the-clock to address any alarms.

    Establishing an unfailing closed-loop supply chain

    CGT begins and ends at the patient’s bedside, highlighting the critical importance of a closed-loop supply chain. This system necessitates an unbroken chain of identity and custody to ensure consistent reporting channels for the track and trace of materials. Achieving a closed-loop supply chain requires organizations to implement robust technological tracking systems that meticulously record the conditions of the therapy throughout the entire supply chain, encompassing precision recording and documentation methods to maintain visibility into patient-specific product batches and infusion schedules.

    Leveraging the robust processes of a strategic partnership can ensure full traceability across the entire supply chain. Cryoport Systems’ Chain of Compliance®, for example, establishes comprehensive identification of the equipment and processes involved in managing the environmental control of commodities throughout the supply chain. It covers various aspects, including equipment performance, requalification history, commodity history, courier handling and performance, calibration history, and correlation competencies linking in-field events to equipment performance. Developed to comply with ISO 21973:2020 standards, Chain of Compliance® guarantees adherence to stringent quality protocols across all services and facilities globally. By providing robust data management, this process effectively mitigates risk and enhances understanding of variability within the supply chain no matter where you or your facilities are located.

    Scaling operations to support accelerated, strategic growth

    The CGT industry faces significant hurdles when it comes to scaling operations. A pressing issue that inhibits growth lies in the shortage of talent and experience, which impedes the expansion of manufacturing capacity. The issue with finding talent is seen within 96% of respondents from a survey performed by Accenture acknowledging that recruiting top talent will continue to pose a major challenge in the foreseeable future. This widespread sentiment underscores the prevailing skepticism within the CGT industry, suggesting that scaling operations may be unattainable without the infusion of skilled personnel and dedicated project support.

    Leveraging strategic partnerships can be a game-changer for CGT companies aiming to scale as it allows them to tap into the expertise and infrastructure of a partner rather than directly investing in building their own facilities and staff. With this approach in mind, Cryoport Systems’ BioServices offerings are meticulously engineered for scalability, drawing on insights from industry experts to ensure seamless expansion. Their proficient teams in the CGT sector collaborate closely with clients to devise strategies for storing, receiving, distributing, and managing valuable biomaterials. From the initial stages of raw or starting cellular materials to the delivery of manufactured therapy to patients, their BioServices capabilities provide essential support. By entrusting Cryoport Systems with supply chain competencies, CGT clients can redirect their focus towards lifesaving research, eliminating the need for additional in-house overhead.

    Leveraging strategic partnerships to accelerate results

    In the quickly evolving realm of cell and gene therapy (CGT) development, the importance of strategic partnerships cannot be overstated. CGT companies encounter many challenges from infrastructure hurdles to compliance demands, which necessitate expert guidance and support. In this dynamic landscape, alliances with industry leaders like Cryoport Systems prove instrumental through tailored expertise, infrastructure, and resources. These partnerships accelerate progress and fuel innovation, enabling CGT companies to navigate complexities and seize opportunities for growth.

    As Cryoport Systems continues to lead with innovation and expand its footprint across Europe, the company reaffirms its dedication to propelling the CGT industry forward. By remaining ahead of market trends and fostering strategic collaborations, Cryoport Systems remains a cornerstone in supporting CGT companies throughout their journey. With cutting-edge facilities, seasoned teams, and an unwavering commitment to excellence, Cryoport Systems is positioned at the forefront of advancing the CGT sector. As the demand for advanced therapies surges, Cryoport Systems stands ready to meet the evolving needs of the industry, empowering researchers and manufacturers to pioneer lifesaving breakthroughs for patients worldwide.

    About Cryoport Systems

    Cryoport Systems is a comprehensive supply chain partner for the life sciences industry focused on meeting the challenges of the global cell and gene therapy market. We excel in the specialized management of the biopharma supply chain through our comprehensive offerings in logistics, BioServices and Biostorage, cryopreservation, and consulting. With our expansive platform and decades of temperature-controlled supply chain expertise, Cryoport Systems helps Enable the Outcome™ for advanced therapy programs, safely and securely guiding critical therapies to patients in need.

    Learn more at www.cryoport.com.

    Explore other topics: Cell therapyEuropeGene therapy

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