The benefit of using a standard set of prefilled syringe components consistently for a variety of products is that a solid
and robust data package can be established to support licensure application. These categories of information include:
- Description, general information, material of construction, method of manufacture
- Suitability according to the FDA container closure guidance document which encompasses protection, compatibility, safety and
- The quality control aspects such as incoming specifications, industry standards, etc.
- Stability results, for example, will reveal some of the common stability issues and challenges depending on the product types,
- Manufacturability when new products in the same set of prefilled syringe are being transferred to production facility, where
deep process knowledge of the platform prefilled syringe systems have been accumulated with definitive enhanced production
efficiency and quality control.
This is important because it’s expected to provide all of this information in a submission as summarized in Table I.
A holistic and integrated prefilled syringe platform toolbox approach will streamline development with higher probability
of success even in the complex and challenging case of vaccine products. More importantly, such an approach is not only beneficial
to technical challenges, but also provides economic benefits. We sincerely hope that the cost of innovation for a new prefilled
syringe system is not so prohibitive that vaccine products cannot afford to achieve the intended health impact to society.
Table I: General submission information requirement.
We like to thank Anna Coslovi and Francesca Beccai for their preliminary results to characterize the charge heterogeneity
of glycoconjugate vaccines.
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