Search results for " laboratory" in Articles / App Notes
Article
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…
Article
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…
Article
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…
Article
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…
Article
Regulatory Challenges in the QbD Paradigm
The potential applications of quality risk management in quality systems, regulatory operations, development, facility and equipment design, material management, production, laboratory control, stabil…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
A summary of the production scale-up from laboratory scale is presented in this white paper. More detailed descriptions of the individual upstream and downstream processes are presented in separate ap…