As the demand for parenteral products increases, companies are seeking solutions that offer the benefits of prefilled formats while reducing lead times and costs associated with sterile fill-finish services. The projected growth of sterile injectables in the next decade makes finding such solutions crucial. Aseptic manufacturing technology combined with injection molding offers a more flexible and resilient supply chain, even during global crises such as the COVID-19 pandemic.
In this webinar, a case study will be presented that showcases the advancement of product design based on customer needs, especially in the context of injectables. The study will demonstrate the progression from using multi-dose glass vials to single-dose prefilled injectors, and how this evolution aligns with the future of technology being in plastic. The speakers will emphasize the logical progression with a focus on integrating quality, convenience and safety into innovative technology. The FDA has outlined key considerations for transitioning to innovative combination products which will also be discussed. By following a device development approach, a modular and customizable design can be achieved, offering endless possibilities for creating the appropriate drug delivery solution.
Register for this webinar to learn how scalable fill-finish, a compact supply chain and cost-efficient manufacturing can solve drug delivery challenges for prefilled injectables.
Tony Wasilewski, VP Pharmaceutical Development Services, ApiJect Systems, Corp.
Tony Wasilewski is the Vice President of Pharmaceutical Development Services at ApiJect. Spanning 25 years of expertise in the pharmaceutical industry, Tony has spent much of his career focused on the development and launch of generic injectables. Prior to joining ApiJect, he was Vice President of Program Management & Business Development at Fresenius Kabi. Tony held positions in a range of functional areas in his career, including 503B outsourcing, new product development, aseptic manufacturing and R&D. Tony holds an MS in product design and development from Northwestern University and a Bachelor of Science in Chemistry from Northern Illinois University.
Lauren Greenberg, VP Device Development, ApiJect Systems, Corp.
Lauren Greenberg is the Vice President of Device Development at ApiJect. She brings over 15 years of pharmaceutical and device development industry experience to her role, focusing on the delivery of product designs and characterization of data and methods, while providing strategic and technical direction for the combination product pipeline and bearing primary responsibility for development, verification, validation and advancement of ApiJect’s product portfolio. She also heads development of novel tools and processes to deliver on future product platforms and licensee needs.
Who Should Attend?
- Research & Development
- Manufacturing, Distribution and Supply
- Product/Combination Product Development
- Formulation Developers
- Outsourcing Personnel
- Regulatory Affairs
- Safety & Quality
- Healthcare Professionals
- Project Managers
- Clinical Operations Personnel
- Product Engineers
What You Will Learn
- Identify critical factors to consider when transitioning from a vial to a combination product and how to navigate the challenges involved in this process
- Learn about the next-generation advanced aseptic fill & finish technology for prefilled single-dose sterile injectables and its impact on the pharmaceutical industry
- Explore the history of injectables and the changing demands of customers for enhanced drug delivery systems
- Discover key considerations when transitioning from vials to combination products and strategies to overcome associated challenges
ApiJect™ is a medical technology company creating the future of medical injections.
Our Platform achieves this by bringing together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high precision injection molding. Our Platform’s simple, compact supply chain uses widely-available raw materials, ensuring reliability and resilience. This approach has the potential to enable scalable manufacturing of single-dose prefilled formats (e.g. prefilled syringes) whose cost-efficiency can typically only be found in multi-dose presentations. And in the future, the Platform will include dose-level validation technology on every device to screen out counterfeits and expired medicines.