Search results for " laboratory"
Article
Quality by Design and Extractable and Leachable Testing
He has more than 20 years of analytical laboratory management experience and has managed several extractable and leachable projects for drug manufacturers.
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BioPharm Internati…
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Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…
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Challenges and Trends in Biopharma Facility Design
These structures can be used for laboratory purposes, unit operations, or whole facilities, which then could become cloneable facility platforms or enter into new production needs, for example for the…
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Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
Smaller recombinant antibody fragments a…
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Quality by Design—Bridging the Gap between Concept and Implementation
A key issue with design spaces is that they are often developed at a small scale at the laboratory or pilot level. Despite that, design spaces have to show that they match the quality requirements nee…
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2014 Manufacturing Trends and Outlook
Survey respondents represented research, development, formulation, and process development functions, as well as quality control/assurance, validation, and laboratory management titles at branded and …
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
This binary designation was usually determined during early development for the purposes of regulatory filings, relying heavily on scientific judgment and limited laboratory studies.
Wi…
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Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
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Supplier-Change Management for Drug-Product Manufacturers
Testing Laboratory or Calibration Service Provider
• Failure or out-of-tolerance (OOT) condition of a standard or instrument used for calibration or testing of equipment or material
• Change i…
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Report from India
Pharma industry players brace for challenges as India’s new drug-pricing policy kicks in full gear.
(Dmitry Rukhlenko/Getty Images)
On July 1, India's new…