The journey from early clinical trials to a commercial launch for injectable drugs is intricate, with the choice of delivery system vials, prefilled syringes (PFS), or autoinjectors playing a
pivotal role.
Modern autoinjectors enhance patient experience, adherence, and market competitiveness. However, the transition to such devices requires strategic planning and parallel development can help balance clinical and commercial goals.
Early Development Choices
Traditionally, biopharmaceutical companies favoured vials during preclinical and early-phase trials due to their flexibility in fill volume and dose adjustment. This approach prioritizes speed and cost-efficiency while exploring proof of concept, safety, and dosing tolerability.
However, with the growing focus on self-administration for conditions like diabetes, multiple sclerosis, and allergies, prefilled syringes for autoinjectors are becoming integral. These devices, driven by patient-centricity, not only promote better compliance but also enable companies to differentiate in a competitive landscape.
Parallel Development: A Balanced Strategy
Switching from intravenous (IV) to subcutaneous (SC) delivery and introducing a combination product mid-development adds complexity to both technical and clinical development plans, often requiring bridging studies to evaluate bioavailability, safety, and product comparability, adding time and additional costs to a development program. To address these challenges, biopharmaceutical companies are looking to parallel development strategies.
Parallel development in early phase clinical studies involves concurrent and coordinated advancement of both drug and container/device components from early stages through to commercialization (diagram one). With the key objective of accelerating time to market, close collaboration between pharmaceutical development and injectable device packaging teams is essential to align goals and streamline processes.
Key Components of Parallel Development
- Container Closure Studies
Drug stability and compatibility across vials and PFS are critical. Conducting simultaneous stability tests provides up to two years of data early, enabling smoother transitions to later trial phases. Parallel functional stability testing for autoinjectors, adhering to ISO 11608-5 standards, ensures readiness for deployment should these devices become the preferred delivery method. - Human Factors and Usability Engineering
Parallel studies may also include assessments of usability and patient preference between prefilled syringes and autoinjectors. Conducting usability studies and incorporating human factors considerations early in the design process can help identify potential issues and inform design modifications. Feedback from patients and healthcare professionals helps refine packaging, instructions, and device interfaces, aligning with regulatory requirements while ensuring patient comfort and adherence.
Advantages of Parallel Development
- Faster Time to Market: Coordinating drug and device development eliminates sequential processes, accelerating timelines.
- Cost Savings: Streamlined workflows reduce redundancies and optimize resources, cutting overall costs.
- Enhanced Decision-Making: Early stability and usability data aid in selecting the most suitable packaging, minimizing late-stage adjustments.
- Regulatory Streamlining: Early alignment simplifies compliance for both drug and device components.
Strategic Considerations for Packaging
Packaging Design: Package design is a cornerstone of manufacturability. Collaboration among developers, manufacturers, and stakeholders ensures operational feasibility and reduces costly redesigns. Early design decisions must consider scalability and compatibility with existing infrastructure and tool sets to avoid delays and inefficiencies.
Drug Device Strategy: Typically at phase IIb clinical trials, biopharmaceutical companies seek to make decisions on the therapy’s drug device strategy. Whether to continue with the prefilled syringe as-is, convert to a needle safety device, or insert into an autoinjector to provide ultimate flexibility for various health care professionals, patient populations, or reimbursement schemes.
Considering the Target Product Profile (TPP) / Quality Target Product Profile (QTPP), decisions can be made on whether there is a unique need for device innovation for specific patient populations or if traditional, readily available platforms would be suitable. Companies must choose between leveraging established platforms for lower upfront costs and regulatory ease or pursuing proprietary designs for differentiation and extended intellectual property life. Each path offers trade-offs between risk, cost, and market impact.
Best Practices for Success
- Foster Collaboration: Cross-functional teams, including formulation scientists, regulatory experts, packaging engineers, QA professionals and patient focus groups should collaborate from the outset to ensure alignment of goals, troubleshooting and efficient progress.
- Proactively Manage Risks: Identify potential hurdles early to minimize disruptions.
- Iterate and Refine: Embrace an iterative approach to allow for continuous refinement and optimization based on feedback from user testing, regulatory feedback, and market insights.
- Stay Adaptive: Flexibility in timelines and strategies is crucial to navigate unforeseen challenges.
Conclusion
Parallel development is transforming the path to market for drug device innovations like autoinjectors. By integrating drug formulation and device engineering early, companies can expedite timelines and streamline their clinical to commercial process, ultimately improving patient outcomes.
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