Search results for " quality" in Articles / App Notes
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Implementing the infrastructure of a QbD approach to process development involves formalizing the commitment and the strategy and integrating execution into quality systems. The end result is a road m…
Article
Are You in Control of the Quality of Your mAbs?
…op and qualify assays for monoclonal antibodies (mAbs) and other therapeutic proteins to ensure drug quality.
Sign up to view an on-demand recording and receive a free copy of our poster booklet,…
Article
Biosimilar Quality Requirements
In May 2019, the agency published the draft guidance Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (1) and the guidance Con…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
…to Process Development Forum that continuous processing, ripe with innovation, will result in better quality products, fewer scale-up risks, and long-term economic advantages.
Last year also mark…
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e-Learning: what is quality by design (QbD)?
This free interactive course shares what quality by design (QbD) is all about. The focus lies on applying QbD to process development of biopharmaceuticals.
Key learnings:
- Fundamen…
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Quality by design in biotherapeutics purification white paper
Learn how understanding and addressing variability sources can help you develop robust chromatography processes. The principles and methodologies of biopharmaceutical manufacturing are well …
Article
A Robust Quality Culture Benefits All
Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.
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Achieving the Required Buffer Quality with Inline Conditioning
A study was conducted to compare buffers produced with IC and buffers produced manually to see if their quality was equivalent.
Read full article here.
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Cell Culture Media Considerations and Optimization for Improved Titers and Protein Quality
… Cell Culture Media and Feeds
Read our case study on Improving Cell Culture Titer and Protein Quality
Article
Innovative Chromatography Resins Can Improve Purity and Quality
By: Feliza Mirasol
Recent innovations in chromatography resins offer promising advantages in downstream bioprocessing.
With ongoing efforts to increase monoclonal antibody (mAb) productivi…