Search results for " laboratory"
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Challenges in Analytical Method Development and Validation
Technologies, such as FDA’s quality-by-design (QbD) initiative, may have a positive impact on analytical method development and validation according to Paul Smith, EMEAI laboratory compliance producti…
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Using Quality by Design to Develop Robust Chromatographic Methods
In the case examples discussed in this article, following such a discussion between R&D and receiving laboratory analytical scientists, reversed-phase high-performance liquid chromatography (RP-HPLC) …
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
During this time, he's developed scalable synthesis and utilized process analytical technology to monitor reactions and crystallization from the laboratory to the pilot plant. In 2016, he moved to the…
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The Importance of Partnering for Bioanalytical Studies
BioPharm International spoke with Robert Kernstock, PhD, director, Immunoassay Laboratory Services at ICON, and Neelanjan Bose, PhD, director of Bioanalytical Chemistry at Emery Pharma, both contract …
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Evaluating Surface Cleanliness Using a Risk-Based Approach
A risk-based approach, supplemented with laboratory studies and information from published literature, can be leveraged in the justification to reduce testing during cleaning qualification and continu…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
… of the research and publication process: biological reagents and reference materials, study design, laboratory protocols, and data analysis and reporting (3). Although each contributes to a systemic…
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Setting Standards for Biotech Therapeutics in India
• Lack of in-house laboratory. While IPC has a laboratory for characterization of reference standards related to pharmaceutical products, it is in the process of creating a state-of-the-art laboratory…
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Emerging Therapies Test Existing Bioanalytical Methods
These technologies are challenging to validate and therefore are typically performed in a non-good laboratory practice fashion. There currently are no regulatory guidance documents that govern this bo…
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Putting Viral Clearance Capabilities to the Test
“Even though few model viruses represent the biophysical characteristics of a broad range of mammalian viruses of different virus families, they are still models prepared and kept under laboratory con…
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PDA's Technical Report for Biotech Cleaning Validation
49: Points to Consider for Biotechnology Cleaning Validation, well–designed laboratory-scale studies can be performed using design of experiments, and the data analyzed to understand the cleaning proc…