Executives from GRAM and LTS Discuss Qualities of a CDMO Redefining Innovation
What are the traits that redefine innovation in fill-finish partners? GRAM’s CEO and LTS device leadership come together to discuss how CDMOs can provide greater value to their clients. Watch the webinar below or review the key points here.
Transformative
Combination devices that enable the transition of large-volume treatments to home care are transforming the drug-delivery landscape. Larger subcutaneous injection (e.g., 5 ml or greater) have become relevant with the development of biological drugs that require higher viscosities or dosing. Devices necessitate adherence to specific requirements, including considerations for quality, expedited market entry, capacity, and successful commercial launch. As biologic drugs evolve, they present new requirements that call for innovative devices and primary containers capable of accommodating higher-volume fills. The transformation of CDMOs in their skill sets and equipment requirements to serve clients is evident.
Advancements
As technology advances, customer and regulatory expectations elevate. It is essential to engage the right personnel and invest in modern equipment to meet current standards. Large- and small-volume production is expected to increase, with a notable rise in the number of molecules developed in smaller volumes, driven by technological advancements. The development of targeted therapies with a diverse array of molecules reflects this trend, as evidenced by recent developments in vaccines and GLP-1 medications. Large volume production will remain a significant aspect of the industry, especially for on-body devices, as its importance is undeniable.
Expertise
The development of a drug combination device cannot be conducted solely by a CDMO. It requires specialized expertise from professionals well-versed in their respective fields. From the perspective of sterile filling, the process is considerably more complex due to regulatory considerations that encompass both drug and medical device regulations. Complexity increases because the filling process directly influences device performance, including resistance, fill levels, and bubble size. These elements require greater precision and tolerance.
Cultivate
CDMOs are uniquely positioned to facilitate the development of new drugs and the concurrent commercialization for multiple clients, enabling them to cultivate expertise that supports rapid technology transfers and the efficient scaling of production. Fostering a strong relationship with the device’s developer is essential to the successful realization of the product. Drug ecosystems excel in their individual domains; however, true innovation is achieved through collaborative efforts that challenge existing boundaries. This collaboration allows pharmaceutical companies to focus on their strengths while relying on the specialized expertise and collaboration of CDMOs and drug-device companies to address their manufacturing challenges.
Patients
Pharmaceutical companies are focusing on the patient experience and optimizing drug delivery earlier in product development than ever before. Patient-centricity underscores the growing reliance on CDMOs and their strategic partnerships as experts in their fields, further solidifying their role as essential partners in the pharmaceutical development process. By cultivating relationships with transformative, advanced, and experienced CDMOs, pharmaceutical organizations can focus on their core competency: developing new therapies and solutions for patients.
Watch the webinar with Grand River Aseptic Manufacturing, LTS, and Fierce Pharma.