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A Challenge with Single-Use Technology: Protecting Bulk Drug Substance (DS) during cold chain handling, storage, and transport
Joe Cintavey, BSME/MBA University of Cincinnati -
Gore & Associates
The issue of single-use container durability during cold chain handling is well known in the biopharmaceutical market, particularly at freeze and transport temperatures down to -80°C. The extractables and leachables profile of materials commonly used in containers is another concern. This presentation will discuss novel technologies that address both the durability and purity challenge that biopharmaceutical manufacturers face.