Search results for " monoclonality"
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FDA Provides Guidance on Bispecific Antibody Development Programs
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
FDA published final guidance …
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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…
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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…
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Cytiva Advances Fiber Chromatography Technology with New Launch
The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.
On Jan. 27, 2021, Cyti…
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Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…
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Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
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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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Securing Today’s Biomanufacturing Supply Chain Using Transformative Supply
Today, biologics represent a $250 billion industry, which is two times what it was worth only 10 years ago. Though monoclonal antibodies are expected to continue dominating the market, a more divers…
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Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis
Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
By Mario DiPaola, …
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Tools and Processes for Mature and Emerging Therapies
New technologies and thought trends provide innovative biomanufacturing approaches for a range of therapies.
By Rita Peters
Conference sessions and new technology introductions at recent t…