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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.
Each June, West recognizes Pride Month, which promotes and supports the self-affirmation, dignity, equality, and increased visibility of the Lesbian, Gay, Bisexual, Transgender and Queer or Questioning (LGBTQ) community.
<p><span class="Subheading-1">Daikyo Crystal Zenith<sup>®</sup> container systems may be your solution!</span></p><p><span>Bisphosphonates are a class of drugs used to help prevent loss of bone density in diseases such as osteoporosis. This class inhibits increased loss of calcium from bones (bone resorption) by promoting apoptosis (elimination of cells absent release of harmful substances into surrounding area) of osteoclasts. Osteoclasts function to break down bone to assist with bone maintenance and to help balance blood calcium levels; however, in the case of patients with osteoporosis, there is an increased level of bone resorption that results in a need to manage and decrease the presence of the osteoclasts.</span></p>
On March 26, the Delaware Valley Chapter of PDA and West Pharmaceutical Services, Inc. co-sponsored a workshop: Defining a Strategy for Combination Products, at West’s headquarters in Exton, PA. More than 150 people from 45 companies that provide drug products and combination products attended. In prior PDA events, combination product regulatory challenges have been cited often as an area both of interest and confusion. This workshop aimed to address them.
The drive for high-quality packaging has helped manufacturers focus on increasing consistency of performance in devices such as auto-injector and patch injection systems. In addition, there is an increased focus on providing drug delivery systems that are easy to use. A consistent quality of components can help to improve performance and ensure delivery in the home environment, while user-centric systems can help assist with compliance.
Prefillable syringes have become an increasingly important option in the packaging and delivery of injectable drug products. The prefillable syringe serves two major purposes for the administration of a drug. The first is as primary packaging by assuring that there is no adverse effect on the identity, strength, quality, purity or potency of the drug over its shelf life. Second, a prefillable syringe is a delivery system designed to administer the appropriate amount of the drug to the patient reliably
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