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Understanding Risks of Biologic Drugs and Injectable Drug-Device Combination Products



Growth in biologic drugs in the development pipeline of products has led to growth in the use of injectable drug-device combination products. Figure 1 shows this growth exhibited by drugs that have received FDA approval between 2011-2020 in the various package/delivery formats.

Risk Considerations Specific to Combination Products

Looking at history, there are several clear examples that justify why special considerations must be given to biologics and combination products. The most important aspect to remember is the fact that nothing, including the biologic drug product, should be evaluated solely as an individual component. Although risks specific to each component must be understood, because a system is only as strong as its weakest link, typically issues occur at the intersection of various components of a system.

Three examples are:

  1. Leachables from an elastomeric component interacting with polysorbate 80 was one of the factors in the Eprex® drug product, which led to the increased occurrence of pure red cell aplasia in patients as reported in Kidney International in 2005 (1).
  2. Silicone oil distribution issues that led to the auto-injector stalling and delivering an incomplete dose of Enbrel® (etanercept). Recalls occurred in various geographic regions of the globe due to the potential of the glass syringe breaking within the auto-injector (2). The root cause was the poor silicone oil distribution within the glass syringe used within the auto-injector – resulting in higher-than-expected syringe extrusion forces.
  3. Tungsten residuals from the staked needle insertion process used in glass forming of pre-filled syringe (PFS) barrels led to protein aggregation in Neupogen® (filgrastim) and several other biologic drugs (3).

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Fran DeGrazio has over 35 years of experience in the pharma packaging and delivery industry with extensive expertise in injectable drug products, including vial container closure systems and pre-fillable systems for combination products. Fran has held numerous technical roles at West Pharmaceutical Services, Inc., including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories, and Scientific Affairs. In her current role as CSO she is responsible for leveraging scientific and regulatory understanding across the enterprise. Fran received the Philadelphia Business Journal 2018 Healthcare Innovators of the Greater Philadelphia Region Award and the Healthcare Business Woman’s Association Luminary Award for West in 2017.

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