Search results for " Mabs" in Articles / App Notes
Article
Process Development: 2020 Reflections and 2021 Possibilities
On the note of mAbs, another area of interest in 2020 was strategies to improve the mAb manufacturing process and streamline overall bioprocessing operations. mAb manufacturing productivity can be gre…
Article
Reimagining Affordable Biosimilars
A typical study for complex biologics, such as mAbs, includes the following components: assessment of acute toxicity (two-weeks to one month) via single- and multi-dose studies, including evaluation o…
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Flexible Facilities for Viral Vector Manufacturing
“Compared to mAbs, viral vectors are much larger, more complex molecules that are highly susceptible to various factors in their manufacturing environment, such as mechanical shear, pH, and temperatur…
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Best Practices for Selecting a Top-Quality Cell Line
Once scaled up, the mAbs should be 5 to >10 g/L in the bioreactor. “This high level of productivity must also be maintained for more than 60 generations at the high-density and in the defined media co…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …
Article
Unifying Continuous Biomanufacturing Operations
Benchtop systems, then, could be sufficient for the commercial production of some mAbs. Integrated continuous bioprocessing is already regularly being achieved in small research labs, according to Bon…
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Improvements in Protein A Chromatography
Process Development Forum speaks about Protein A chromatography with Glen Bolton, Scientific Director at Amgen. Bolton recently published a paper “Role of more than 40 years of improvement in Protei…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Reichert, MAbs. 7 (1), pp. 1–8 (2015).
2. S.D. Wijesuriya, R.L. Cotter, and A.H. Horwitz, Protein Expr. Purif. 92 (1), pp. 14–20 (2013).
3. D. Guo et al., Biotechnol. Bioeng. 107 (1), pp. 163–17…
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Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
Article
Modular Manufacturing Platforms for Biologics
In fact, modular systems are best for mAbs and are likely better than any other system design for these products, states Jornitz, as most new mAb processes are at the scale of 2000 L, which fits withi…