Search results for " packaging"
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
…nts, metabolic waste products, or leachables from polymers used in single-use equipment and flexible packaging films (24, 25). It has been difficult to identify functionally equivalent alternatives t…
Article
A Second Modular Biopharma Facility Opens: KUBio in Hangzhou
The center will also include filling and packaging lines providing end-to-end manufacturing capability in a single facility.
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Design and Qualification of Single-Use Systems
• Packaging and shipment containers must be designed to effectively protect the SUT component or assembly during transport from the manufacturing or assembly site, as well as ease and security of unpa…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
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A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Demand for custom formulations and packaging have increased, as has customer demand for quality control reports.
Several suppliers reported facility expansions to increase capacity for these vital…
Article
Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
Antibodies and their derivatives are increasingly important as biotherapeutics, precision diagnostics, and essential tools for biological research. Techniques to screen and characterize large number…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
By Sean Milmo
A consultation period…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
Article
Best Practices in Qualification of Single-Use Systems
These include, but are not limited to, packaging integrity, appearance/identity, contamination, and extractables assessment. The alignment of criteria should include any variability in appearance, suc…