Search results for " market"
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Antibody Production in Microbial Hosts
With more than 200 recombinant proteins on the market today, the biopharmaceutical industry is expected to reach approximately $180 billion by 2016 (1). Therapeutic mAbs and their derivatives—such as …
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Selecting the Right Viral Clearance Technology
Filter manufacturers are working to address these issues, and Riske looks forward to seeing solutions on the market in the future. Another important development for the biopharmaceutical industry has …
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Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Therapeutic monoclonal antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving …
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Manufacturing and quality control helps ensure the supply of a consistent quality product to the market. CQAs are determined using the “best” knowledge at a given time; they may later have to be revis…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Some of the reasons leading to supply shortages could be increased market demand, poor product quality and/or GMP practice, increasing regulatory expectations, or limited or competing manufacturing ca…
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USP Stresses Pharmacopeial Standards at CPhI China
The USP requirements for elemental impurities, FDA’s metrics program, and the generic-drug market were also discussed.
USP stressed the need for compliance with global regulations and standards du…
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What’s In a Name? For Biosimilars, A Lot
International Nonproprietary Names (INNs) are given to most drugs early in the drug-development process, even though many of these drugs never make it onto the market. The INN is established by the Wo…
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Host-Cell Protein Measurement and Control
Regulatory agencies from other countries and emerging markets may have their own wording on HCP control, but it is generally accepted that a sensitive, validated method is required to monitor residual…
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Use of Multivariate Data Analysis in Bioprocessing
…r and their biosimilar version, the regulatory authorities may consider the approval of the drug for market authorization with minimal clinical studies data.
A quantitative approach has been presen…
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Ensuring the Quality of Biologicals
…to establish the comparability of a biosimilar to an original biological product in the context of a marketing authorization application.
Even though users of the Ph. Eur. are supportive of the e…