BIO San Diego

As the industry continues to move beyond traditional vial presentations, transitioning to prefilled syringes presents both significant opportunities and complex technical challenges from formulation science to device performance and patient experience.

Key subjects discussed: 

• Key formulation adaptations required when moving from vial to PFS
• The importance of engaging with the primary container provider as early as possible to ensure container suitability to avoid downstream risk
• How to align primary container and device functionality with drug characteristics to optimize delivery, safety, and patient experience

Learn how holistic, early-stage alignment between formulation scientists, container partners and device teams can reduce development risk, prevent late-stage changes, and enable a smoother, faster transition to patient-ready PFS presentations.

As patient populations diversify and sustainability expectations rise, early design decisions have never been more critical. Discover how prioritizing patient needs, aligning technical realities, and environmental responsibility can lead to more robust, compliant, and scalable solutions.

Key learning points:

• Understanding the patient experience and user needs, including patient populations, human factors engineering, and usability
• Navigating technical requirements and constraints across primary packaging and formulation
• Designing for manufacturability and scalability, evaluating platform and bespoke approaches and end-to-end supply chain considerations
• Integrating sustainability through carbon footprint reduction, recyclability, and informed material choices
• Balancing performance, compliance, and environmental responsibility

With drug device combination products becoming more complex, robust functional testing is no longer optional – it’s essential for risk reduction, regulatory confidence and product lifecycle success.

Key topics covered:

• Key ISO standards for prefilled syringes, safety devices, autoinjectors, pens, and on-body delivery systems
• The role of functional testing in assuring DDC performance, mitigating risk and supporting regulatory expectations
• How automated testing can be implemented using standard test systems
• Practical approaches to applying testing throughout process validation and batch release 

This session will provide practical insight into building testing strategies that support quality, compliance and long-term manufacturability.

With parenteral combination products experiencing rapid growth, the demand for flexibility and scalability from clinical through commercialization has never been greater.

Key areas explored: 

• How to construct a solution that best fits your program needs to enable seamless scale up from clinical trials to commercialization
• The key early decision points for an integrated clinical-to-commercial strategy
• Cost, time, and risk reductions associated with an integrated clinical and commercial manufacturing strategy
• Best practices for final assembly, labeling, packaging, and testing along the development pathway to commercialization

Whether your program involves prefilled syringes, needles safety devices, autoinjectors, or pens, we will provide practical guidance to help you navigate today’s evolving manufacturing landscape with confidence.