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Anti-VEGF therapeutics for the treatment of ophthalmic conditions such as neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME) have significantly improved patient prognoses, in some cases preventing or reversing progression to blindness. Routine injections into the eye of recombinant protein drugs such as bevacizumab, ranibizumab or aflibercept have proven to be efficacious in neutralizing the binding of over-expressed vascular endothelial growth factor (VEGF) proteins to their corresponding cellular receptors, thus interrupting the angiogenesis signaling pathway which otherwise leads to the disease states. In short, anti-VEGF injections are preventing or restoring vision loss for millions of people world-wide.
Despite the widespread success of these drugs, when it comes to the safety of patients receiving ophthalmic injections, there is a need to improve the packaging and delivery systems. Injection of silicone oil either from traditional prefilled or disposable syringes can cause floaters in the vision or Weiss rings. Endotoxin, microbial contamination or particulate matter from packaging or delivery systems can lead to conditions such as sterile intraocular inflammation or even the very serious condition of endophthalmitis, which can cause blindness. For this reason, cleanliness requirements for ophthalmic primary packaging and delivery systems are more stringent than typical parenteral applications.
West can help to make ophthalmic injections safe with primary packaging components and assemblies that can mitigate risks of protein aggregation and offer low endotoxin levels. Daikyo Crystal Zenith® syringe assemblies contain Flurotec® coated elastomeric closures which provide exceptional barrier properties to reduce leachables. West 0.5 mL Flurotec® plungers for glass syringes and Daikyo Crystal Zenith® 0.5 mL conical vials are also commercially available to help support all lifecycle management aspects of ophthalmic drug delivery. West is dedicated to delivering safe solutions for complex drug delivery.
For more information, contact a Technical Customer Service (TCS) representative, or visit our Knowledge Center.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® and Flurotec technology is licensed from Daikyo Seiko, Ltd.
FluroTec® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and in other jurisdictions.
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.
We’re excited to share that Amgen has selected West’s Daikyo Crystal Zenith® vials with FluroTec® stoppers to contain its FDA-approved therapy IMLYGIC™ (talimogene laherparepvec).
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.
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.
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.
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