Search results for " downstream development"
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Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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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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Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…
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Top Tips for Successful Development of Antibody Chromatography Processes
In this interview, Jakob Liderfelt, Product Manager at Cytiva, discusses main challenges faced during chromatography process development for mAbs and mAb variants such as fragments and bispecific a…
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Top Process Development Trends for 2022 and a Look into 2023
FDA approved 37 drugs in 2022, within the normal range for the past decade or so. The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of thes…
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Developing a HIC polishing step for removal of mAb aggregates
This article describes the development of a flow-through (FT) polishing step using hydrophobic interaction chromatography (HIC) to remove mAb aggregates.
It includes:
- The use of HTPD plate…
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Process Development and Control for New Modalities
Increasing molecular diversity leads to more challenges in process development and control. Advancements in technology for manufacturing and online analytical monitoring have not caught up…
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High-Throughput Process Development in Biopharma
Efficient development of the manufacturing process is a crucial component of overall biopharmaceutical development. During early process development, high-throughput process development (HTPD):
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …
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High-Throughput Process Development Handbook
Time-to-clinic and time-to-market are two key factors for successful biopharmaceutical development. Efficient development of the manufacturing process is a crucial component of the overall project…