Search results for " biopharmaceuticals"
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
Article
Platform Technologies Improve Protein Expression
The availability of several molecular biology tools developed in the recent past by the scientific community in diverse applications beyond biopharmaceuticals is starting to make a difference, agrees …
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Intense efforts in bioprocess development have been made to improve the production of CHO-based biopharmaceuticals by cell line engineering, improved methods for cell growth, and upregulating the post…
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N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
By Aled Jones
Protein glycosylation, the addi…
Article
Being Thorough When Transferring Technology
… to participate? Meaning, will they feel ownership and take responsibility? And very importantly for biopharmaceuticals, are they capable and competent? The latter can best be assessed by reviewing t…
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A Q&A with Eric Langer: CMOs Embrace New Technology
Process Development Forum speaks with Eric Langer, President and Managing Partner at BioPlan Associates, and the author of a number of biopharma studies, about the 2016 13th Annual Report and Survey…
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Downstream Processing Continues to Worry CMOs
CMOs are working hard to improve performance by investigating new technologies for filtration and purification.
By Eric S. Langer
Downstream processing continues to be a significant pain poi…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals, such as lower capital investment and increased flexibility, are now well docu…
Article
Antibody Production in Microbial Hosts
Similarly, yeast-expressed aglycosylated monoclonal antibody ALD518 (Alder Biopharmaceuticals) exhibited a half-life of 25 days (comparable to the wild-type glycosylated form) and significant improvem…
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CMOs Concerned With Cost of Single-Use Equipment
Suppliers indicate prices for single-use equipment are likely to increase.
By Eric Langer
Contract manufacturing organizations (CMOs) have been enthusiastic adopters of single-use technologi…