Search results for "biopharmaceutical" in Articles / App Notes
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
To date, no infectious virus has been transmitted to a patient by a cell-line-derived biopharmaceutical. Extraneous vesiviruses, however, have recently appeared in bioreactors (2–5), and porcine circo…
Article
Establishment of New Modern Plasma Fractionation Facilities in Asia
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The plasma fractionation industry has often been regarded as a curiosity or an anachronism of the much larger pharmaceutical and biopharmaceutical industries, but this perception d…
Article
Preclinical Evaluation of Product Related Impurities and Variants
In this 38th article in the “Elements of Biopharmaceutical Production” series, the authors focus on the approaches for sample preparation of preclinical evaluation of safety and efficacy taking into c…
Article
QbD Improves Cell-Culture Process Control
Mammalian cells are most frequently used as the hosts for manufacturing complex biopharmaceuticals, and cultivation of these host cells is a key factor in the production of biotherapeutics. The cultiv…
Article
Critical Quality Attributes Challenge Biologics Development
By Susan Haigney
Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an understanding of a product and the processes used to make that product. The International C…
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
In a draft guidance for industry, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base (December 2015), the agency outlined a process for biopharmaceutica…
Article
Single-use Bioreactors Have Reached the Big Time
Challener
Single-use bioreactors available from various vendors today are robust and provide the high-performance necessary for commercial manufacturing of biopharmaceuticals. Significant advances…
Article
Evaluating E&L Studies for Single-Use Systems
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biopharmaceutical companies have increased the adoption of single-use systems (SUS) and components (i.e., polyethylene bag…
Article
Improving Process-Scale Chromatography
By Cynthia Challener, PhD
Chromatography is a crucial step in the purification of biopharmaceuticals and accounts for a significant portion of downstream processing efforts (time and cost) for bio…
Article
Innovation vs. Capacity: How CMOs Compete
Perhaps the biggest is the reduced propensity of global bio/pharma companies to outsource manufacture of their newest products, especially biopharmaceuticals. New product approvals earned by global bi…