Search results for "analysis"
Article
Setting Standards for Biotech Therapeutics in India
To establish these standards, candidate materials can be sourced from multiple Indian manufacturers (with certificate of analysis) and calibrated against the originator product. Development of referen…
Article
Applying GMPs to the BioPharma Supply Chain
They need to have capabilities and processes for participating in (multi-company) root-cause analysis and investigations. Suppliers need to understand and apply the concept of corrective action preven…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
Cell counts, antibody titer, protein quality analysis, and qPCR array. Cell-culture samples were counted by a Vi-CELL (Beckman-Coulter) using the trypan blue exclusion method. The pH and metabolites i…
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FDA Seeks Metrics to Define Drug Quality
Yield analysis or abnormalities of product per batch over time can be an advance sign of other process or raw materials problems.
In its comments, Pfizer describes four levels of quality performan…
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Essentials in Establishing and Using Design Space
They can be organized as a factor/response type risk assessment relative to CQAs or they can be organized as a failure mode effects analysis (FMEA) type approach relative to CQAs. Either way, a clear …
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Downstream Processing and Purity Analysis
For downstream laboratory-scale purification, performed using standard, non-disposable equipment, approximately 10 L virus harvest from the upstream proce…
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The Smart Benefit of Digital Systems in Preclinical Studies
Data gathering and deep data analysis in the preclinical stages of development are growing increasingly crucial as the biopharmaceutical industry strategizes ways to better decrease costs while speedi…
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Optimizing your Cell Culture Process to Improve Productivity
This is a new area of research; however, we have found that the spent media analysis can help support this industry. We are also able to support regenerative medicine product development—as well as be…
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Webcast: Repeatable, automated SPR titer assay for adeno- and adeno-associated viruses in crude samples
Viral vectors are commonly used in clinical trials to evaluate gene therapies. Due to instability, these vectors are difficult to produce and analyze. Current assays lack the sensitivity requi…
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Setting Up Bioprocessing Systems for Digital Transformation
In both upstream and downstream manufacturing, the operating paradigm for many years has been batch-based processing, with final product analysis being carried out offline, at the completion of a batc…