Search results for " skill" in Articles / App Notes
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Biopharma Advances Demand Specialized Expertise
Maintaining a focus during early development on eventual commercial manufacturing requirements, while balancing limited development resources requires a broad base of coordinated, organizational skill…
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Modular Manufacturing Platforms for Biologics
Challenges associated with modules and pods
“Building one module is easy; building an integrated modular facility takes a lot more skill and expertise,” observes Almhem. Some of the oft-mentioned …
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Drug Discovery and Development in India
… says, “They include insufficient innovation, limited access to high risk funding, short supply of skilled professionals, and specialized equipment.”
Low levels of intellectual protection continu…
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Finding Opportunities in Brazil
…n attracted by scientific and technological development, rising domestic demand, and an increasingly skilled workforce. Struggling infrastructure, extreme bureaucracy, and corruption, however, remain…
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DoE Provides Benefits, but Preparation Is Necessary
It is all of the extra training to develop my applied statistics skills, including six-sigma training and seminars, that helps me on the job,” he states.
About the Author
Cynthia A. Challener …
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Challenges in Analytical Method Development and Validation
Consideration should be given to the availability of required analytical and supporting equipment, software, critical reagents, standards, controls, and analysts who are skilled in the relevant analyt…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Of these three options the reliability approach (Option 3) is the most robust, but requires sophisticated statistical skills. This option may be reserved for only very high risk CPPs.
…
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Operational Excellence: More Than Just Process Improvement
Deviation reports were made the responsibility of a single investigator with specific analytical and investigation reporting skills. The reports were then designed to connect the event and its root ca…
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Flexibility in Biopharmaceutical Manufacturing
Many CMOs have become skilled at this and trade on their flexibility. Innovator firms are heading in the same direction.
STAINLESS STEEL VERSUS SINGLE USE
For many, the use of disposable or…
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A Look Ahead at BioPharma Manufacturing and Regulation
Additionally, agency reviewers have also had the opportunity to maintain their scientific and medical skills by participating in clinical work, research, or teaching opportunities at UMD and GU CERSI.…