Search results for "analytical"
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Report from the 6th International HTPD Conference
Many of the challenges are the same with analytical technologies and data handling. However, when working in a cGMP environment, these challenges become even more important to tackle.
Analytics…
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Maximum Output Starts with Optimized Upstream Processing
Developing and scaling up manufacturing operations and analytical testing capabilities are, however, requiring major innovation and the courage to move away from conventional constructs, asserts Botto…
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Setting Up Bioprocessing Systems for Digital Transformation
Lenich says that with the increased complexity inherent in mAb manufacturing, there is a new focus on process analytical technology (PAT) to ensure that not only are measurements correct, complete, an…
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Driving Improved Access to Biosimilars
The agency also published draft guidance on the analytical methods to be used to establish biosimilar comparability and quality (12). According to reports on May 13 and May 21 in the Regulatory Affair…
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Development of Purification for Challenging Fc-Fusion Proteins
1]
Analytical techniques
Protein concentration was measured using a NanoDrop 2000 (Thermo Fisher Scientific). Microplate protein concentration analysis was measured using a S…
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Reconciling Sensor Communication Gaps
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors and probes. Single-use systems …
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Lessons Learned Accelerate Vaccine Development
“The lack of true platforms, with a few exceptions, means that there is a lack of standard cell lines with associated process and analytical frameworks for the manufacturing and release of products,” …
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Ligand-Binding Assays and the Determination of Biosimilarity
“Only a functional assay, such as an LBA or CBA, can fully address this issue,” says Michael Sadick, senior manager for large molecule analytical chemistry with Catalent Pharma Solutions.
For mono…
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2014 Manufacturing Trends and Outlook
Process analytical technologies
More than half of the respondents reported using process analytical technology (PAT) in manufacturing operations. High-performance liquid chromatography was th…
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A Look Ahead at BioPharma Manufacturing and Regulation
…s manufacturing, novel manufacturing technologies, excipients and complex dosage forms, and process analytical technology (PAT) and quality-by-design (QbD) approaches. What does FDA and the industry …