Prefilled Syringes constitute a most important product class – for anteris medical customers and for us
When it comes to the development of injectable pharmaceutical products, the prefilled syringe is the most important product class to date in terms of number of units. Prefilled syringes are used as hospital products, often in combination with a needle safety device, and just as often as home-use products, often manufactured into an auto-injector.
Liquid drugs in prefilled syringes are often considered simple products (where the syringe is nothing more than a primary container for the drug) and development times are often underestimated. Yet, in practice many developers experience significant challenges. Prefilled syringes are in fact not so simple combination products, but rather injection systems consisting of several components, some independent, some attached. All components have to be considered and included in requirements definition, specifications, risk assessment, and testing. And of course, whether or not a certain component is suitable and will work as part of the injection system entirely depends on the drug to be injected and may require feasibility testing to assess the performance of the system.
anteris has many years of experience with literally dozens of PFS products, and offers broad support from consultation, gap analysis, risk management, to broad regulatory and development support all the way to interacting with Health Authorities and compiling the relevant parts of the regulatory dossiers.
- Prefilled Syringes
- 21 CFR part 4
- Combination Product
- Combination Product Labeling
- Injection System
- Glass Syringes
- Polymer Syringes
- The challenges we encounter (and address) repeatedly fall into the categories of (a) ensuring that components work together and work with your drug substance, (b) interacting with the suppliers of the components, (c) planning, testing, and reporting of combination product development to ensure smooth registration, and (d) setting up a suitable supply chain including suppliers, our customers, and often CROs.
- Sharing our experience and recommendations (consulting)
- Generating technical documentation under the customers Quality Management System or under ours (ISO 13485 certification may or may not be required)
- Support with verification testing and Human Factors studies
- Interacting with Health Authorities or Notified Bodies as required
- Support of the regulatory dossier and regulatory filing all the way to market introduction