Search results for " scaling"
Article
Science Focus Fuels Successful Process Development for Startups
“What we learned while carrying out tech transfer, scaling up the process, and manufacturing over 300 autologous clinical batches that were then delivered to close to 10 countries served as a basis fo…
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
…
Article
Hybrid Bioprocessing: A Q&A with Andrew Sinclair
Process Development Forum speaks about hybrid bioprocessing with Andrew Sinclair, President and Founder of BioPharm Services
How would you define hybrid bioprocessing?
Hybrid processing is n…
Article
Trends in Single-use Bioreactors
Representatives from industry supplier companies address innovations, reliability, barriers to adoption, and the role of singIe-use bioreactors in bioprocessing.
By: Randi Hernandez
Whil…
Article
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Topics covered include:
1:47 - Where the industry is headed with real-time analysis
3:17 - Scaling up
4:57 - Cell perfusion
7:16 - Criti…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
STEVE
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Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates, shares insight into regulatory require…
Article
Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Modeling and miniaturization were two key take-home messages from the 4th High Throughput Process Development (HTPD) conference organized in October 2017 in Toledo, Spain. The conference brought tog…
Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…