pharmabio consulting

Prefilled Syringes and Related Biologic Drug/Devices: Market Trends and Regulatory Acceptability

The current state of prefilled syringes (PFS), including reusable autoinjectors, passive retractor devices, and dual-chamber prefilled syringes for freeze-dried products, is discussed. Prefilled syringes allow customization of dose, dose accuracy, patient self-treatment, convenience, compliance, fast administration, functionality, and reliability. These devices additionally spare expensive biologics by reducing waste, avoiding secondary contamination, and decreasing human error.

The PFS must provide seal integrity, sterility, stability, and compatibility with biologics. It should avoid leachability and needle stick injuries. Prefilled syringes can also be a suitable alternative to costly or intellectual property (IP)-protected devices for biosimilars, a newly-emerging class of medicines.

The regulatory, medical practice, and other criteria to choose a plastic PFS as an alternative over a well-established glass PFS will be addressed. The impacts of quality and manufacturing aspects in selection of prefilled syringes are also highlighted. Further topics include: How much experience is there with plastics of approved products? What are risk factors of a plastic PFS in manufacturing and use? What are distinct physicochemical features? What are the risks of medication errors with a PFS with regard to dose delivery or misuse?

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