Search results for " quality"
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
Quality Considerations for Using AI in Bio/Pharma
Schniepp, distinguished fellow at Regulatory Compliance Associates, stresses that a robust quality management system and document control are necessary when adding AI to a process. “I also worry about…
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In May 2019, the agency published the draft guidance Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (1) and the guidance Con…
Poster
Strategies for optimized cell culture media: Effectively using design space to influence product quality
Balancing the many individual media components required to achieve high titers and support critical protein quality attributes can be challenging. Here we highlight a statistical design strategy to op…
Article
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…
Article
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…
Webcast
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.
Webcast
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.
Article
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 …