Search results for "analytical" in Articles / App Notes
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Participants explored strategies for analytical method development, assay validation, product characterization, specification setting, and for establishing relevant manufacturing controls for these hi…
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Continuous Processing for the Production of Biopharmaceuticals
The success of continuous manufacturing technologies relies highly on the utilization of real time analytical tools coupled with superior control strategy. The implementation of process analytical tec…
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
The large number of samples produced challenges the throughput of existing analytical technologies. Assimilating all of the knowledge generated can be so overwhelming that the full benefit of the tech…
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Cleaning of Dedicated Equipment: Why Validation is Needed
…esidues are too low and therefore the potential residues would not be detectable with the available analytical methods (2).
• The acceptance criteria are too low and cannot be achieved (i.e., for…
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FDA Approves First Biosimilar
Christl said in January 2015 that a major drug development concern with biosimilars is addressing analytical differences. She said that some biopharma companies fail to establish a strong foundation o…
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Setting Standards for Biotech Therapeutics in India
The detailed study testing protocol should include validated method to be followed for analytical testing, storage, and handling along with the procedures for reporting and submission of results.
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DoE Provides Benefits, but Preparation Is Necessary
The solution for LaBrenz is to use an open, read-only database that can be shared between multiple groups, such as preformulation, formulation, and analytical development groups, so that each unit can…
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Challenges of Protein Aggregation During Purification
Benefits of PAT
Advances in process analytical technology (PAT) provide an opportunity for more effective control of protein aggregation in bioprocessing, according to Vedantham. “Dynamic light sc…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
But in some cases, powerful analytical tools such as mass spectrometry, can be employed to deconvolute the results of PK studies conducted with heterogeneous source materials. To study the effects of …
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Analyzing Proteins Using SEC, MALS, and UHPLC
The characterization of proteins involves identification of their complex chemical and physical structures and requires the use of a range of analytical techniques. Size exclusion chromatography (SEC)…