Search results for " HTPD"
Article
Development of Purification for Challenging Fc-Fusion Proteins
The second round of HTPD was performed for one CEX resin under narrower operating ranges in a flow-through mode. The selected resin was a strong cation exchanger with a negatively charged sulfonate gr…
Article
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…
Poster
Accurate comparability assessment of a biosimilar interferon in process development
This application note describes how to achieve accurate comparability assessments using Biacore™ T200 and
Amersham™ WB system in the development of a biosimilar. This is exemplified in this study…
Article
Q&As with Industry Leaders
…artner at BioPlan Associates
3rd HTPD Conference
Phil Lester, Co-Organizer of the HTPD Conference
…
Article
Developing a HIC polishing step for removal of mAb aggregates
It includes:
- The use of HTPD plates to select the optimal resin as well as running conditions
- The use of a design of experiments (DoE) to optimize the running conditions
- A Monte Carlo simul…
Article
How to Use Multiwell Plates With Manual Operation
During process development, aspects like robustness, scalability, and GMP production come into play. FDA initiatives such as quality by design (QbD) put demands on better process understan…
Article
How Well Do You Know Process Development?
HTPD. DoE. Process understanding. Check your mastery of these and other essential terms by taking this quick quiz.
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Article
Tools and methodologies for smarter downstream process development
Scibetta
Smart process development is a collection of approaches to improve process outcomes and speed up process development.
In this video, John Scibetta, Advanced Chromatogra…
Article
Process Development: 2020 Reflections and 2021 Possibilities
The challenges posed by the COVID-19 pandemic in 2020 brought about many unprecedented lessons and promising developments in the biopharmaceutical industry. Last year in particular reenforced the ne…
Article
Selecting Chromatography Formats for Your Process Development Workflow
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Development of robust purification processes requires significant time and resources. The quality-by-design initiative by the FDA puts additional demands on process deve…