Search results for "buffers"
Article
Trends in Downstream Bioprocessing
Downstream processing involves the recovery and purification of protein therapeutics for biopharmaceuticals, vaccines, and other biologics. It involves the removal of insoluble cell debris and parti…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
The following ar…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
A team of scientists collaborated on a project to transfer a conventional manual concentration/diafiltration process for siRNA production.
ABSTRACT
The use of small-interf…
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Evaluating the Use of Continuous Chromatography
When used with a perfusion or fed-batch bioreactor, continuous chromatography can help reduce the amount of resins and buffers needed. It also provides greater flexibility for processes and uses a sma…
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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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Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…
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What If You Could Remove Your Antibody Aggregates Already in the Protein A Step?
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In this study, the potential of Protein A chromatography to separate antibody monomer from HMW species was investigated. A design of experiments approach…
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Process Development: 2020 Reflections and 2021 Possibilities
These approaches include pre-weighed, ready-to-dispense solid packaging systems, ready-to-use diluted buffers, and others.
Bioprocess Development Forum readers also focused on upstream predictabil…
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Scaling Up Novel Therapies
Prime examples, he says, are recipes with long and shallow linear gradients, as well as pH specifications for process buffers that can only be achieved off-line in the lab. Developers may also use a w…
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Reducing Cross-Contamination Risks in Process Chromatography
Changes in extractable and leachable profiles for contact materials when exposed to process buffers for several days, weeks, or even months in a fully continuous process workflow must also be addresse…