​The company focuses on industry trends in injectable packaging and drug delivery and explores challenges related to the fundamental performance requirements of the combined product.

Patient-friendly products such as prepared syringes and automated delivery platforms are increasingly dominating the injectable packaging and delivery industry as the healthcare industry innovates in drug development, continues to focus on drug safety and efficacy, and shifts from intravenous to subcutaneous delivery. For example, a combination product consisting of a cardstock bottle and a wearable syringe system has seen an increase in FDA review and use. The growth of this category repeatedly reflects the need for simpler solutions for elevated-dose biologic drug delivery systems.

The SmartDose™ delivery platform and wearable Syringe are examples of this innovative combination of cardstock bottles and wearable syringes, demonstrating the strength of Western products and its continued pursuit of technological innovation. SmartDose™ is a wearable electronic syringe that can be loaded with a large dose of liquid medicine and preprogrammed to deliver the drug at a preprogrammed rate, enabling rapid or sustained subcutaneous injection as needed.

With the development of these innovative injectable combination products, meeting regulatory approval requirements and promoting product marketing has become the industry's primary challenge.

The review, approval and listing of consolidated products is an extremely complex process involving various links and aspects.

A key area of concern in this survey is how to define the fundamental performance requirements of a product and formulate control strategies for product lifecycle management.

Basic performance requirements and related design controls are highly essential data and documentation in the application process of the combined product. Design control requires overall planning of all control requirements related to the combined product and its components.

At the same time, a comprehensive testing strategy will be essential for regulatory filings. At the core of these product development activities is an understanding of the basic performance requirements that the device components and the final combined product should achieve from a risk management perspective, that is, to ensure that the clinical performance of the device adequately meets the design control of the intended drug delivery performance of the combined product.

However, the survey found that about half of respondents failed to take a risk-based approach to defining the fundamental performance requirements of their products. That means they face a higher risk of failure. If they are not able to do the upfront work effectively, they will later face challenges in resolving regulatory issues related to performance testing.

A properly designed and effective product lifecycle control strategy is extremely critical for the successful approval of portfolio products. As the market increases its focus and development on combination products such as prepared syringes and automated dosing platforms, players in the injectable packaging and dosing industry need to strengthen their ability to respond to fundamental performance requirements.

As a global packaging and delivery system company for injection containers with a history of almost 100 years, Westfield drives product development and innovation based on the principle of "Quality by design". It not only provides downstream companies with single products such as high-quality pharmaceutical packaging components and drug delivery systems, but also continuously provides high-value integrated solutions for the development, manufacturing, testing and supply chain of injectable and combination products. Ranging from pharmaceutical packaging and dosing system products, professional analysis of detection, the filling molding service, device assembly, production and support of laws and regulations at various stages of drug development, help simplify the biological medicine, innovative medicine, generics firms' product life cycle, successfully cope with the challenge of increasingly changing regulations and shorten product time to market.

With 100 years of expertise and experience in packaging and drug delivery, Westfield is committed to being a trusted partner for established and emerging pharmaceutical companies in the Chinese industry.