Search results for " Q"
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Furthermore, with the increasing emphasis on Quality by Design (QbD), there is a need to develop paradigms to apply QbD not only to mAbs but also to other BioTx.
Early biotechnology products in th…
Article
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…
Article
Reimagining Affordable Biosimilars
For biosimilars, factors that significantly impact affordability and development time include: development cost, variability in product quality, and low success rates of trials.
Cost of biosimil…
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Continuous Manufacturing: A Changing Processing Paradigm
Other advantages of continuous manufacturing include consistent product quality; smaller equipment; streamlined processes; low process cycle times; reduced operating costs; increased flexibility; elim…
Article
Modular Manufacturing Platforms for Biologics
There are numerous benefits related to quality control with building and qualifying units off site. If a full module is unrealistic because of budget or existing architectural constraints, a piecemeal…
Article
Maximum Output Starts with Optimized Upstream Processing
“The latest iteration of technologies is being developed with scalability, process intensification, and lean principles in mind to ensure quality and reliability for the life of a process,” he asserts…
Article
Quality by design for biotechnology products—part 1
…klejohn, Jim Precup, John Towns
ABSTRACT
The International Conference on Harmonization (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Ap…
Article
Virus-like Particles as Therapeutic Moieties of the Future
ES–DMA quantifies the external size of VLPs based on their electrical mobility, with resolution in the sub-nanometer range. Such high resolution allows analysis of even small shifts in particle size a…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
During this period of explosion in the application of CHO expression systems, considerable efforts have been made to improve recombinant protein production to meet the demands of high quantity and con…
Article
N-Glycan Analysis of Biotherapeutic Proteins
The impact of glycosylation on protein function means that glycosylation can be a critical quality attribute (CQA), making the characterization of N-glycan structures an essential part of the biothera…