Search results for " specification" in Articles / App Notes
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
EMA, Guideline on Development, Production, Characterization and Specifications for Monoclonal Antibodies and Related Products, EMEA/CHMP/BWP/157653/2007 (December 2008).
7. ICH, ICH Topic Q6B Spec…
Article
Design of Experiments for Analytical Method Development and Validation
Verify the Model and Determine the Impact of the Method on Specifications and Capability
Run confirmation tests to confirm settings improve precision, linearity, and bias. Evaluate the impact of…
Article
Trends in Downstream Bioprocessing
Downstream processing involves the recovery and purification of protein therapeutics for biopharmaceuticals, vaccines, and other biologics. It involves the removal of insoluble cell debris and parti…
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Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
Article
Report from the 6th International HTPD Conference
The biggest challenge is still the people and Quantitative Structure-Activity Relationship (QSAR) plus mechanistic modeling were two key take-home messages from the 6th International conference devote…
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Determining and Optimizing Dynamic Binding Capacity
Dynamic binding capacity (DBC) indicates the quantity of a specific biomolecule that can be bound during a chromatography purification step under a specific set of process conditions. Determ…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Balancing critical process parameters against competing requirements for critical quality attribute (CQA) specifications. We also touch upon continuous versus batch manufacturing.
Topics…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.
Feliza Mirasol
Among the challenges in upstrea…
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…
Article
Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.
By Cynthia A. Challener
As upstream processing drives toward higher efficiencies in meeti…