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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).
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.
It is an exciting time to be in the Cell and Gene therapy industry. The astounding growth and development we have witnessed in the cell & gene therapy industry over the last decade is bringing life-changing therapies to the patients who have been so anxiously awaiting them. <br /><br />At the same time, as with any new drug class, challenges that may not have been considered during the drug development phase may suddenly show up and stand in the way of overcoming that last hurdle: Packaging and delivering your precious new molecule to the patient.
In a previous <a href="/es-es/blog/2012/may/lifecycle-planning"><span style="text-decoration: underline;">post</span></a>, my colleague Fran DeGrazio discussed lifecycle planning and the use of a single material for packaging components from development through commercialization. There has been a great deal of innovation around drug container materials. Although glass has been the traditional material of choice for drug containment, it has significant limitations including breakage, glass particulate, visual quality and functional performance.
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