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China has now stepped into its “golden age” of biopharma; this year regulators approved the country’s first biosimilar product, HLX01. Developed by Shanghai Henlius Biotech, it will be used primarily for treatment of non-Hodgkin’s lymphoma. Biologics are sensitive large molecules, so selecting the appropriate packaging and delivery system is critical. To this end, West Pharmaceutical Services, Inc. (“West”) recently held China BioPharma Summit for Injectable Drug Packaging and Delivery Systems in Suzhou. Over 200 persons attended.
A broad range of topics were discussed by speakers from West, Daikyo Seiko, Ltd., China National Pharmaceutical Packaging Association (CNPPA), Shanghai Food and Drug Packaging Materials Control Center, Shanghai Henlius Biotech, Wuxi Biologics, and GBI. Highlights included:
West is committed to staying abreast of world-wide drug product developments and supporting customers in getting the right packaging and delivery systems for their products. For more on West, contact an Account Manager or Technical Customer Support (TCS) representative.
Spotting a quality issue on a stopper or plunger can be difficult. While a trimming or molding defect may be noticeable, embedded particulate or foreign contamination may be far too small for the human eye to see. <br />
There are many benefits associated with the use of combination products (e.g., SmartDose® and SelfDose® Drug Delivery Platforms). Since combination products are often patient centered, they are designed to be convenient, assist in maintaining a drug therapy from home, and help to enable better compliance. To ensure these benefits, developers must formulate and execute a proper design verification study to minimize impacts by unknown risks. <br />
Selecting a container closure system (CCS) is an important part of the pharmaceutical commercialization process. It is important to ensure that the components selected are compatible with the drug product to be packaged; however, it is equally important to ensure that the components are compatible with each other. Here we provide background on the importance of correct pairing between vials and stoppers and showcase <a href="/zh-cn/products/vial-containment-solutions/stoppers/4040-lyotec-lyophilization-elastomer-stoppers">lyophilization stoppers V-50-I (13mm) and S-87-I (20mm) in the 4040/40 Gray formulation</a> that can be paired with any vial blowback geometry.
<br />In 2016, the China Federal Drug Administration (CFDA) made two announcements regarding packaging of parenteral drug products. Per these announcements, stability studies of packaging materials should refer to protection, compatibility, safety and functionality properties.
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