Search results for " pharmaceutical"
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…mpurities (PRI), as defined by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q6B (8), and could have potential implications on the safety a…
Article
Going Small to Achieve Success on the Commercial Scale
“This approach to scale-down modeling is in the earliest phases and largely limited to large pharmaceutical companies and university research groups with the resources and computing power required,” J…
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Biopharma in 2015: A Year for Approvals and Innovations
First Hospira Biosimilar mAb Approved in West Europe, Randi Hernandez, Pharmaceutical Technology, Feb. 17, 2015.
3. Global & USA BioSimilar Market Analysis Report 2015-2021, Research and Markets, h…
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mAbs to Watch in 2016
Although the pharmaceutical manufacturers developing these mAbs will likely seek various indications for their products, the preliminary indications include treatments for various cancers, multiple sc…
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Implications of Cell Culture Conditions on Protein Glycosylation
Special cell-culture considerations for biosimilars
Biosimilars are “generic” versions of protein pharmaceuticals that must be highly similar to the innovator drug in order to be classified as such…
Article
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
To date, the majority of monoclonal antibodies (mAbs) have generally targeted a particular antigen; however, there are several additional antibody formats currently in the development pipelines of pha…
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Antibody Fragments and Their Purification by Protein L Affinity Chromatography
Antibodies and related proteins comprise one of the largest and fastest-growing classes of protein pharmaceuticals. A majority of such molecules are monoclonal antibodies; however, many new entities…
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The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
By Andrew Harrison, Susan J. Schniepp
The long awaited, anxio…
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Selecting a Comprehensive Bioburden Reduction Plan
69, (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations, published June 2015.
Targeting Bioburden
BioPharm: What type of planning is necessary to target all asp…