Search results for " monoclonal"
Article
FDA Provides Guidance on Bispecific Antibody Development Programs
Of note, many aspects of a bispecific antibody development program will be similar to monoclonal antibody development programs. This guidance discusses unique aspects for chemistry, manufacturing, and…
Article
Evaluation of Fibro PrismA for Scalable Single-Use mAb Purification
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In clinical monoclonal antibody (mAb) manufacturing, capture on protein A chromatography resin gives excellent recovery and purity. However, because clinical batch siz…
Article
A Small-Scale Model to Increase Yield in Cell Culture Perfusion of mAbs at Large Scale
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We have developed a reliable small-scale model for a monoclonal antibody (mAb) perfusion process using TPP® TubeSpin® Bioreactor tubes and the ReadyToProcess WAVE 25 R…
Article
Cytiva Advances Fiber Chromatography Technology with New Launch
27, 2021, Cytiva announced the launch of HiScreen Fibro PrismA, the newest product available for early monoclonal antibody (mAb) purification process development. The product complements HiTrap Fibro …
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Updating Viral Clearance for New Biologic Modalities
…extracellular debris, they require meticulous filtration, even in more established processes such as monoclonal antibody production.
However, demonstrating viral clearance is even more difficult …
Article
Reimagining Affordable Biosimilars
Advances in preclinical development
Analytics
The complexity of biotherapeutic molecules, in particular monoclonal antibodies (mAbs), lends themselves to fascinating targets for analytical…
Article
Scaling a mAb Production Process to Xcellerex Bioreactors
This article discusses moving a monoclonal antibody (mAb) production process from a microscale bioreactor to the Xcellerex XDR single-use platform.
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Article
Securing Today’s Biomanufacturing Supply Chain Using Transformative Supply
Though monoclonal antibodies are expected to continue dominating the market, a more diversified pipeline that includes, for example, DNA and RNA molecules and cell and gene therapies, is anticipated a…
Article
Methods Accelerate Biosimilar Analysis
Mirror image of peptide maps of reduced/alkylated and endo-Lys C digested monoclonal antibody product lots (Upper: Innovator product; Lower: Biosimilar product).
Such a quantitative approach, i…
Article
Tools and Processes for Mature and Emerging Therapies
While technology advances for more traditional biologic-based drugs such as monoclonal antibodies are evolutionary, the processing requirements for emerging cell therapies and gene therapies may requi…