Search results for " design"
Article
Using Multiple Techniques in Biosimilar Analysis
It also illustrates that exploring orthogonal techniques, and indeed, letting them ‘compete’ with one another, can enhance experimental design, especially for products challenging the resilience of a …
Article
A Plastic Pipeline for Commercial Bioprocessing?
Olivier Loeillot, general manager, global product bioprocess, Cytiva—which supplies both single-use and traditional stainless-steel equipment—says up to 70% of new plants are being designed to use sin…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
CBER had granted the RMAT designation to 24 products as of June 30, 2018, and more new products seek to qualify for that treatment.
CBER also is working with the National Institute of Standards…
Article
Understanding Validation and Technical Transfer, Part 2
It is convenient to break down equipment qualification into several steps such as design, installation, and operational as described below for the coffee brewing example.
Tasting studies may ha…
Article
Gain Efficiency in Process Development
By carefully designing and evaluating your experiments, sufficient information for optimizing your process can be obtained with a minimal number of experiments. However, process development still dema…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
The map then was designed to target these drivers using various metrics. While the most relevant metrics are still evolving, they will be useful in identifying specific deficiencies and eventually est…
Article
Platform Technologies Improve Protein Expression
…latform technologies for protein expression ranging from the choice of cell line, expression plasmid design, cultivation medium, growth conditions, equipment, scalability, stability, and matching pur…
Article
Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
Several years ago, we started a development project to design and validate the next-generation protein A resin, MabSelect PrismA, which was just introduced to the market. Now, 1M NaOH can in fact be u…
Article
From Darwin to Recombinant Fc Multimers
In the era of QbD, there has been a lot of focus on Design of Experiment (DoE) approaches. Though considered as a good and established approach, Sejergarrd pointed out several of the inherent drawback…
Poster
Evaluation of Protein A resin lifetime during extensive use (overloading) in continuous chromatography mode
This application note compares the performance of MabSelect SuRe pcc resin designed for continuous capture of mAbs, with the conventional high-capacity Protein A resin MabSelect SuRe LX. The study was…