Search results for " 3D modeling"
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Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
Smaller recombinant antibody fragments a…
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Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
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QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
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In silico optimization of AAV full/empty particle separation with AIEX
The separation of adeno-associated virus (AAV) with high yield and purity is an increasingly important challenge. Mechanistic modeling is the tool of choice to find the optimal AIEX chromatogr…
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Top Tips for Successful Development of Antibody Chromatography Processes
In this interview, Jakob Liderfelt, Product Manager at Cytiva, discusses main challenges faced during chromatography process development for mAbs and mAb variants such as fragments and bispecific a…
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HTPD 2023 conference is coming up. What will be discussed and what happened last time?
The 6th international conference devoted to high-throughput process development (HTPD) and smart process development (PD) will take place on October 31 – November 2 in Valletta, Malta.
A…
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Digitalized PD: Speeding up downstream process development
Mechanistic models enable the simulation of chromatography processes based on fundamental natural laws, such as fluid dynamics and thermodynamics. In silico simulations of chromatography proce…
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Top Process Development Trends for 2022 and a Look into 2023
FDA approved 37 drugs in 2022, within the normal range for the past decade or so. The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of thes…
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Simulating chromatography processes in the growing molecular diversity
The increasing complexity and diversity of development pipelines poses new challenges for product manufacturing. Mechanistic modeling can play a key role in overcoming these challenges as they…