1. Charter Medical has extensive experience with biological materials but how has the rapid growth and development of the advanced therapies industry shaped the organisation?
Charter Medical has long been recognized as a provider of single-use products for blood management and bioprocessing. Today we are applying those capabilities and expertise to cell therapy applications. Our team of engineers works with companies on the cutting edge of science and technology that need a partner to evolve and grow with their discoveries. Our clients today include some of the world's leading innovators in cell and gene therapy. However, when we first met them, they were just getting started and needed guidance on how single-use solutions could address their manufacturing and logistic challenges.
As our customers grew, we transformed the organization to better align with their development needs for advanced therapies. We've added expertise in quality, engineering, and manufacturing to support the rapid growth of the industry. We've also made capital investments in response to a large number of customers entering the market right now and are planning a significant expansion to our facility's manufacturing capacity. The size and organizational structure of Charter Medical allow us to remain agile and respond to customer needs as they arise, making us an ideal business partner for custom solutions.
2. What impact can bags, containers and tubing have on the development and commercialisation of advanced therapies?
We believe single-use technologies will make personalized regenerative medicine a reality. Many cell therapy companies will tell you that the science for developing immunotherapies is already there. The challenge they face is scaling up therapies to treat more patients, which in turn creates additional manufacturing and logistics challenges. To increase the scale and speed of cell production, manufacturers must collaborate with solution providers like us on developing innovative technologies and techniques, including cell storage and transportation alternatives.
Single-use technologies can help mitigate the cost impacts of manufacturing small-batch sizes for personalized use. We have seen first-hand how single-use components and storage solutions address the need to transport critical therapeutics from the manufacturing facility to the patient. Our bags, containers, and tubing components provide design flexibility to accommodate various customer applications in the advanced therapy market. Some of our solutions are in use for the manufacturing and logistics supply chains for FDA-approved therapies.
3. Automation is critical for reducing COGs and improving scalability, can you tell us how you’re working in partnership with technology providers to help with the complexities of automating bioprocessing systems?
We understand that the common denominator for advanced therapy manufacturing is the need for closed systems with automated and controlled processes. Meeting this need will ultimately result in the delivery of high-quality products at an affordable price to patients. The current maturity level of the industry dictates flexibility in unit processes for the immediate future. Therefore, as solution providers, we seek three-way partnerships with equipment suppliers and technology providers to ensure all requirements are being considered early in development. It's critical for us to deliver dynamic single-use solutions that will scale-up from the pre-clinical stage to full-scale commercial bioprocessing.
An area where we can impact the cost of goods sold (COGs) is with custom-designed cell separation and expansion, storage, and transfer assemblies for closed operations in automated systems. By reducing the number of open operations and transfer steps, the risk of product loss due to microbial contamination can be significantly reduced.
Our company has successfully designed and developed custom units for automated fill lines consisting of multi-bag manifolds. In one instance we were able to incorporate pressure-sensitive technology into our bag design as well as SMART packaging design to minimize set-up times and reduce the risk of product loss. The process was interactive in response to design changes in the automated fill line. As the customer tweaked their process, we adjusted the design of our solution to fit their automated fill device.
4. The issue of tubing standardization is a topic of increasing importance to our audience. As one of the leading suppliers of tubing and transfer sets, can you explain Charter Medical's outlook on this?
One of the key challenges with improving the manufacturing process for advanced therapies is standardizing fluid-transfer tubing. As an industry leader, we are committed to working with stakeholders to develop standards through our participation in Phacilitate's working group on the topic.
Fluid transfer systems for cell therapy have been relying on technologies borrowed from the blood management and biopharma industries. These industries have more established and controlled practices with some components regulated as medical devices. Given the differences in the processes, these components may not meet the evolving needs of the cell therapy industry.
Although standardization would reduce cost and validation workload, we must consider the numerous fluid transfer processing steps involved and how standardization may slow the discovery of new therapies. Each has specific requirements regarding polymer chemistry, volume, surface area, and interoperability between components.
We must also consider the breadth of storage environments, including ambient, freezing, and cryopreservation. We believe the process should begin by understanding the customer's polymer chemistry needs and reaching a consensus on the materials needed to create the solution. From there the other issues can be addressed.
5. Charter Medical has a flexible product range; how do you typically collaborate with customers to create the right bag for each individual need?
Our customers rely on us to provide materials knowledge and engineering expertise to customize a solution for their individual needs. Collaboration must start with a full understanding of the requirements for the product such as the type of cellular material being processed, transportation and storage conditions, and the final delivery mechanism.
Generally, customers are in favour of a standard off-the-shelf product that can be customized to fit their needs, which usually involves modifying either the component or the assembly. Although, some customers want a complete design and build from scratch. At Charter Medical, building a custom product follows a rigorous stage-gate process whereby custom products are manufactured under the same current cGMP quality system used to manufacture medical devices. Thus, ensuring they meet the strictest quality processes for management, design, and manufacturing control.
Successful collaborations are driven by our robust quality-control system and a multidisciplinary team dedicated to exceeding customer expectations for addressing manufacturing and logistical needs for single-use products. What makes our partnerships so successful Is knowing our products are in direct contact with therapies Intended for injection into the human body. Our customers have complete confidence in our ability to deliver products that meet regulatory and cGMP certification.