Sterile Filling Readiness in the Drug Device Delivery Ecosystem with Bausch+Ströbel, SKAN, and GRAM
Behind the Curtain: Sterile Filling Readiness in the Drug Device Delivery Ecosystem
Go behind the curtain as we delve into sterile filling equipment readiness and its crucial role in the drug delivery innovation ecosystem. Understanding the collaboration between Contract Development and Manufacturing Organizations (CDMOs) and their equipment vendors is essential for ensuring successful and timely product delivery. Our expert panel, featuring representatives from Bausch+Ströbel, SKAN, and Grand River Aseptic Manufacturing, will discuss how sterile filling equipment adapts to variations in drug delivery systems while maintaining compliance with regulatory requirements.
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Where do CDMOs fit into the drug device delivery ecosystem?
CDMOs play a critical role of in the development of drug delivery devices, and early collaboration with the pharma or biotech customer (the “owner”) is important. Early discussions allow all parties to address key questions regarding the drug product and its interaction with the device to avoid delays. Particular attention is drawn to the viscosity of the drug solution, as not all viscous solutions are suitable for aseptic filling in the chosen container. In short, we encourage early engagement to ensure a successful integration of the drug product with the delivery system.
A pharma or biotech customer (the “owner”) wants GRAM to fill the primary container used in their chosen drug delivery system. What happens next?
Collaborate, align, and prepare with the filling equipment vendor, Bausch+Ströbel. Flexible filling lines, like those offered by GRAM, allow Bausch+Ströbel to modify the system without significant alterations. Ensure that the filling equipment is aligned to meet the specifications of the primary container. For new or unfamiliar packaging materials, a development team will be engaged to conduct testing and evaluate how the materials can be integrated into existing systems. With a comprehensive database, Bausch+Ströbel references previous implementations to streamline processes and ensure compatibility with specific customer requirements.
What should pharma and biotech consider when looking into a device for their product?
- Primary container specifications
- Stopper specifications
- Tub and nest specifications
- Characteristics of the drug product
- Viscosity
- Partnerships with container suppliers
- Conducting proactive testing of components
- Suppliers with a robust infrastructure and flexible systems
Many components have never been used in the market before. As an equipment manufacturer, how do you ensure a CDMO can successfully run these components?
Equipment manufacturers can take advantage of offline solutions for Good Manufacturing Practice (GMP) equipment. It’s important for there to be regular communication between equipment vendors, owners, and suppliers of devices and container closures. Developing customized testing programs is essential. Additionally, creating processes and systems that enable most work to be conducted outside the GMP system is beneficial. This approach allows test results to be integrated into customer solutions without impacting the operational equipment.
How do you ensure Annex 1 guidelines continue to be followed with the equipment and industry shifts in demand?
Modular equipment designs facilitate easy modifications with minimal downtime, offering flexibility to manage various components in an aseptic production environment. GRAM and SKAN provide ongoing testing and modeling to address component challenges. SKAN’s isolator testing includes No Touch Transfer (NTT), debagging tests, tub opening tests with particle measurements, and stopper force measurements. By implementing tighter tolerances, processing outcomes can be significantly improved, particularly at high speeds. As automation increases, maintaining consistency in components becomes increasingly critical.
What capabilities and equipment give CDMOs a unique position in the market when talking about syringe and cartridge filling?
GRAM collaborates with suppliers such as SKAN and Bausch+Ströbel to tackle challenges and qualify new components within their GMP system. Their flexible filling equipment can adapt to various applications while maintaining high-quality standards. GRAM’s investments include filling lines for vials and syringes/cartridges, demonstrating a commitment to patient-centered solutions. The changing landscape of drug delivery systems highlights the need for flexibility to meet diverse patient needs and market demands. A collaborative approach and the capability to implement custom solutions are essential for success in this industry.