Search results for " information" in Articles / App Notes
Article
Current Techniques and Challenges Presented in Scaling Between Bioreactors
…nizations which includes CMOs have acquired elaborated template available that captures the critical information, and operating parameters for the transfer process related information. FMEA are the c…
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Assessing Manufacturing Process Robustness
The assessment focuses on analyzing the information and knowledge gained from the three stages of the process validation lifecycle: process design, process performance qualification, and continued pro…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
Especially if you're going to a CDMO, make sure you have all the requisite information that the company needs to actually start manufacturing that product.
With that said, sometimes all the inf…
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Reimagining Affordable Biosimilars
European Medicine Agency (EMA) biosimilar guidance provide recommendations for such predictive tools as supportive information for biosimilarity (17).
Thus, establishing biosimilarity requires an…
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Methods Accelerate Biosimilar Analysis
Intact mass analysis by HR-MS can provide an abundance of information about the integrity of the molecule and glycoforms comprising the protein product or the presence of oxidation, truncation, or oth…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA further outlined in new guidance [3] issued in July 2018 what manufacturing information is needed to support clinical development on chemistry, manufacturing, and control (CMC) information for inv…
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CoAs Help Secure the Supply Chain
This document has a comprehensive list of information suitable to be included in a CoA. The model CoA was developed in conjunction with the Guidelines on the Implementation of the WHO Certification Sc…
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Roadmap Leads to Innovative Biomanufacturing Strategies
Roadmap Leads to Innovative Biomanufacturing Strategies
The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.
By Feli…
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Handbook: Design of Experiments in Protein Production and Purification
The technique allows us to use a minimum number of experiments, in which we systematically vary several experimental parameters simultaneously to obtain suf cient information. Based on the obtained da…
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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…