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Primary container systems for storage and delivery of protein and peptide drugs (i.e., biologics), including vials and prefillable syringes, are typically made of glass or polymer, and include an elastomeric component (stopper or plunger). Proteins adsorb to most surfaces. Generally, the resultant loss of drug is not an issue since the amount adsorbed is on the order of 2-10 mg/mL, or not more than approximately 5 µg per 2 mL vial, or 13 µg per 5 mL vial.
Most biologic drugs, such as monoclonal antibodies (mAbs), are formulated at high concentration (tens of mg/mL), so the actual loss is quite low. However, in those cases where the initial drug concentration is in the range of tens of micrograms per mL, loss due to adsorption to container surfaces is significant. Even for high concentration biologic drugs, an understanding of a protein’s surface adsorption is important.
Several studies using siliconized prefillable glass syringes, as well as glass vials (which are generally not siliconized) have suggested that surface adsorption is the first step that leads to formation of aggregates in solution. Why is aggregation undesirable, even in low amounts? First, aggregation may result in decrease of potency through loss of active protein. Second, and more importantly, numerous studies have demonstrated that protein aggregates are highly immunogenic compared to the unaggregated form. What this means is that development of antibodies to a biologic drug may neutralize the therapeutic activity, rendering the drug ineffective. In addition, if the biologic drug is a protein that occurs naturally in the body, such as a growth hormone or insulin, even the naturally occurring protein will be neutralized, potentially leading to a life-threatening situation.
Studies with containers made of Daikyo Crystal Zenith® cyclic olefin polymer have shown that there is a reduced tendency of proteins to aggregate when subjected to a stress such as agitation. However, each protein is different, and must be evaluated on a case-by-case basis. For more information, visit the Knowledge Center or contact a Technical Customer Support (TCS) representative.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
As biosimilar development is expected to accelerate over the next decade, many customers are seeking packaging recommendations for these drug products. Because biosimilars are extremely sensitive to any changes from the innovator’s manufacturing and packaging processes, in every case it is important to understand the factors that affect the safety, purity and potency of the drug product as it relates to component selection.
In Part I of this two-part series, several of the challenges with USP<789> <em>Particulate Matter in Ophthalmic Solutions</em> were discussed. Namely, the limits were established before routine intravitreal injections existed and the same acceptance criteria are applied to two different particle detection methods with different capabilities. Other challenges include the mismatch between required analysis volume and the very small fill volumes of ophthalmic injections and the lack of translatable limits for the syringe system alone. Regardless of the potential gaps in the pharmacopeial chapter, it is nevertheless clear that for ophthalmic injections, the industry expectations are to strive for the lowest possible visible and subvisible particle levels that are achievable.
Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.
Exposure to light is a concern with numerous medications due to the potential for photodegradation or other chemical reactions during manufacturing, storage, and administration<sup>(1)</sup>. This may result in potency loss, altered efficacy and adverse biological effects. The sensitivity of a drug to a distinct spectral region of light may vary with its chemical structure, photoreactivity, and nature of the dosage form. The photochemical behavior of a drug provides guidance for handling, packaging, and labeling of drug products. The use of the appropriate containers and packaging material can protect the products from the deleterious effects of light.
In an effort to treat more complex diseases, the injectables market has seen high-value molecules dominate clinical pipelines. As modern molecules continue to gain market share, it is becoming the norm for drug manufacturers to plan containment system compatibility earlier in their drug development process due to the sensitivities of their complex molecules. With packaging systems becoming an integral part of the drug development and research process, a challenge drug manufacturers face is the plentitude of choice.
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