Search results for " biopharmaceutical"
Article
Advancing Single-Use Technology Through Collaboration
By Cheryl Zigrand
The use of disposable, single-use components within the biopharmaceutical manufacturing process is not a new phenomenon. Silicone tubing, capsule filters, tissue culture flasks, …
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Generating a Fully Processed Antibody
By Gregory Bleck, Dona York, David Rabuka
The number of more complex biopharmaceuticals in development continues to increase. These include molecules such as virus-like particle (VLP) vaccines, pr…
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Application of Quality by Design to Viral Safety
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The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the quality of biopharmaceuticals. Using this approach, products are developed with a thorough under…
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Setting Up Bioprocessing Systems for Digital Transformation
By Feliza Mirasol
The advancement of digitalization technologies is transforming manufacturing processes and operations in the biopharmaceutical industry. Bioprocessing is no exception, as the ind…
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Improving Upstream Predictability
Currently, he says, 50–60% of biopharmaceutical developers and manufacturers have either implemented or are considering use of perfusion for seed train or production bioreactor steps. Used with high c…
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Moving PAT from Concept to Reality
Still on the learning curve
The biopharmaceutical industry and regulatory agencies have recognized the value of PAT. Although many large multinational manufacturers have adopted and implemented va…
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Leveraging Computational Models of Glycosylation for Biopharma QA
… by work that found considerable glycosylation variation among different commercial lots of the same biopharmaceutical product (4).
Biopharmaceutical glycosylation variability is determined by ma…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
The biopharmaceutical industry faces an increasing demand to accelerate process development while saving on cost and time. A possible solution to alleviate this is by using high-throughput potential t…
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Best Practices for Data Integrity
By Jennifer Markarian
Maintaining data integrity is essential for all biopharmaceutical manufacturing operations. BioPharm International interviewed Dan Nelson, Customer Expe…
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Biomanufacturing Outsourcing Globalization Continues
…nd Europe, according to preliminary data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1).
As part of the survey, biotherapeut…