Search results for " design"
Article
Get to know: mAb variants - eLearning
Key learnings are:
- Structure and binding domains for antibody variants
- Advantages and disadvantages of different antibody fragments
- Design strategies for bispecific antibodies (bsAbs)
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Article
Late stage failures of monoclonal antibodies
Despite the significant developments that have happened in clinical trial design and the considerable experience that the biopharma industry has gained in the past three decades, therapeutic…
Webcast
The GMP of AAV: Purification for Clinical Production
Last, we’ll explore what’s on the horizon for systems and other purification techniques designed for purifying AAV according to good manufacturing practices (GMP) requirements.
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
Interest rose in innovative clinical research methods, such as master protocols, adaptive trial designs, and Bayesian analytical methods to reduce study size and duration. Digital technology was adopt…
Article
Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
I believe Boehringer Ingelheim recently published that they experienced a 75% reduction in the process characterization activities using mechanistic models versus a conventional design of experiments …
Article
Using Digital Twins to Model Process Chromatography
… in upstream feed or material quality, one can mechanistically understand the dynamics and develop a design space that will function with simple controls even in the face of process variability.
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Article
Insights and Strategies for Successful Development of Scalable AAV Processes: Part 2 of 2
Topics covered include:
1:00 – The upstream approach for AAV production, such as finding the balance between different parameters in the design of experiments to create a robust production proc…
Webcast
Strategies and emerging technologies for mAb capture
You will learn:
• Strategies and emerging technologies for intensifying the mAb capture step
• How the design of your upstream mode may determine your optimal downstream solution
• When techn…
Article
Achieving the Required Buffer Quality with Inline Conditioning
Buffer production often becomes a limiting factor when the goal is to design more flexible facilities. To overcome this, Janssen Biologics BV decided to investigate inline conditioning (IC) technology…
Article
Lessons Learned from the Biopharma Industry's Response to the COVID-19 Pandemic
Topic covered include:
1:38 – The typical time frame for process design and process qualification for a biopharmaceutical development program
2:10 – The driving forces for the rapid scal…