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Rising cold chain demands, biologics, and combination products

Sensitive biologic drugs must be kept within recommended temperature ranges.


Biologic/biopharmaceutical treatment advances continue to develop within the life sciences community. That’s exciting, but as Logistics Viewpoints explains in its article, “The Dubious Reliability of Online Pharmacies Cold Chains,” the effectiveness of such treatments may become questionable should the products be exposed to temperature excursions—not merely until they reach the patient, but apparently right up to the time of consumption.

No question, the importance of cold chain packaging and distribution continues to rise. Geoffrey Glauser, director of global packaging technology, Pfizer, will address “Temperature-controlled Packaging for Biopharmaceuticals, the Cold Chain, and the Regulatory Environment” at the May 27 Healthcare Packaging Conference & Workshops at the Hyatt Regency Princeton, NJ.

Meanwhile, “Proposed FDA cGMP Regulations Impact Pharmaceutical and Biotech Industries,” at Fair brings to light a proposal concerning combination products. The site notes, “This proposed rule clarifies confusion applied to devices, drugs and biological products that are used to create combination products.”

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