Search results for "biopharmaceutical"
Article
A Look at the Affinity Chromatography Landscape
With the advent of next-generation biopharmaceuticals, chromatography material suppliers have been challenged to develop affinity ligands and support systems that enable the separation and purificatio…
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
Do you agree?
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In a draft guidance for industry, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base (December 2015), the agency outlined a process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…
Poster
Collaborating to address the bioburden challenge
Striving towards a bioburden-free process, biopharmaceutical companies and their suppliers must collaborate. To meet this challenge, Cytiva is committed to continuous improvement of its chromatography…
Poster
Heating-cooling and liquid-liquid mixing characterization at a range of volumes
Single-use mixers have been used in the past two decades in biopharmaceutical plants to replace the use of stainless steel vessels. Heating/cooling and mixing properties are the two key parameters imp…