Search results for " biotherapeutics"
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Design Considerations for a Commercial Cell and Gene Therapy Facility
…view, there is increased focus on establishing commercial manufacturing facilities for these complex biotherapeutics. The workflows of a cell therapy or a gene therapy differ from each other and from…
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The Antibody Boom
Antibodies continue to dominate the biopharma market. Analyzing the strategies employed by successful players in the field could provide invaluable lessons for those hoping to enter it. Get insight in…
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Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
At the recent Biotherapeutics Analytical Summit, Fredrik Sundberg presented the importance of implementation of a robust analytical control strategy to ensure drug product efficacy and patient safet…
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Webinar On Demand: Expanding SPR Uses in Antibody Effector Function Determination
Critical quality attributes (CQAs) are fundamental to regulatory compliance. CQAs typically include data on how the candidate interacts with target proteins, as well as process-related CQAs such as pr…
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An Analytical Approach to Biosimilar Drug Development
…reasingly required to shift focus to large-molecule characterization and analysis with the growth of biotherapeutics in the pharmaceutical industry pipleline (2).
As a result, demand ha…
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Security of Supply
Getting high-quality biotherapeutics to patients on time requires a concerted effort. Working together, suppliers and manufacturers can better understand raw materials and variations that put processe…
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Protein Analysis with Size Exclusion Chromatography
Size exclusion chromatography (SEC) is widely used in several different analytical applications from basic research to quality control of biotherapeutics. This white paper presents fundamentals abou…
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Advances in Engineering of Protein-Based APIs
Peptides
Although mAbs have led to the development of meaningful biotherapeutics and provide the clearest examples of successful protein engineering technology, Smythe notes that they have si…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity and production. The results, published …
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Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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