Biologics

Schematic of Cryoport’s liquid nitrogen dry vapor shipper.
News
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Sanaria uses logistics partnership to support Malaria vaccines

Cryoport, Inc. a provider of advanced cryogenic logistics products for the life sciences industry, is enhancing its cryogenic logistics support of its Sanaria partnership, which includes Sanaria’s production of malaria vaccine as well as its research and development efforts.
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News
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Biosimilar naming system comes under fire

Industry groups, drug companies criticize proposals citing usability issues.
Winpak: Cold Form laminate
Materials Product Brief
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Winpak: Cold form laminate

Designed for sensitive, hygroscopic pharmaceutical and biopharmaceutical products.
MEMSCap smart electronic medication packaging system tracks each time the medication bottle is opened.
News
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Adherence packaging battles HIV/AIDS in Africa, India

Designed to help prevent the spread of HIV/AIDS in sub-Saharan Africa and India, MEMSCap smart electronic medication packaging system tracks each time the medication bottle is opened.
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FDA committee recommends Sandoz biosimilar for approval

If approved by the agency, Sandoz will market the biosimilar under the name ZARXIO.
Kevin O'Donnell is Vice President, Cold Chain Standards, Practices & Compliance at BioLife Solutions, Inc., and is a Contributin
Column/Opinion
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Test your cold chain IQ

True or false questions about the handling of biologics and drugs in the supply chain.
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U.S. is closer to first biosimilar

FDA officials see no difference between Neupogen and the biosimilar version.
Source: U.S. Food and Drug Administartion, “Pregnancy and Lactation Labeling Final Rule,” 12/3/14
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FDA updates drugs/biologics labeling system

Includes major revisions on pregnancy and breastfeeding, with labeling changes taking effect June 30, 2015. Prescription drugs and biologic products approved after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.
Octapharma, an independent manufacturer of human protein products worldwide, added the PAS-X Track & Trace Serialization Aggregation to Werum’s PAS-X at their production site in Vienna.
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Octapharma adds track-and-trace serialization aggregation

Developer, producer, and seller of human proteins requires a flexible and validated system for marking, identifying, and tracking its products.
FIGURE 1: Experimental set-up: Monitoring set-up in the lab showing three VisiSens detection units (cameras on the right corner) connected to a PC and software screen (a); test vial containing alginate beads in direct contact with the detector unit for CO2 monitoring (b); monitoring set-up allows detection of three parameters pH, O2 and CO2 (c).
Feature Article
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Immobilized plant cells: from DSMZ to the customer

VisiSens technology is used to detect metabolic activities of immobilized plant cells during simulated cell transport in a closed system.

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