Search results for " Mabs"
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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 …
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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…
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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…
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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…
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Continuous Manufacturing: A Changing Processing Paradigm
Case studies with mAbs have shown similar yield and purity compared with batch runs and could be associated with an increase in productivity, they note. Other advantages of continuous manufacturing in…
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Purification strategies for antibody-derived entities: bispecifics and fragments
The diversity of antibody variants in today’s pipeline presents unique challenges for purification. Purification platforms used for many monoclonal antibodies (mAbs) need to be adopted for ant…
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Selecting Chromatography Resins for Bispecific Antibody Purification
Targeting enhancement with two active antibody arms makes bispecific antibodies (bsAbs) highly attractive for the treatment of cancer and other diseases. Their purification can be more challen…