Search results for " monoclonality"

Article 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 …

Article Evaluation of Fibro PrismA for Scalable Single-Use mAb Purification
Read the full article >> 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
Click here to learn more >> 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
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…

Article 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…

Article 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 …

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. Learn more >>

Article 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…

Article 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, …

Article 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…

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