Search results for " efficiency" in Articles / App Notes
Article
DoE Provides Benefits, but Preparation Is Necessary
An added benefit of this efficiency, Yang notes, is the reduced quantity of material needed for formulation development, which can be important early in the development of a biopharmaceutical product …
Article
Continued Process Verification for Biopharma Manufacturing
A manufacturer may also wish to include measures of process efficiency, but beyond these two categories, adding additional measures to those taken during processing will not add significant value to t…
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Challenges and Trends in Biopharma Facility Design
Flexibility, cost efficiency, and speed are characterizing the new generation facilities. High-yield processes, single-use equipment, and modular concepts are tools contributing to the ability to meet…
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Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
Can you tell us why that is?
Eric: Based on our 11th Annual Report, this focus on productivity is changing the way companies outsource, For example, there’s been a real push for more efficiency …
Article
Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility.
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Flexibility and speed
Novavax’s recombinant protein nanoparticle vaccine technology combines the flexibility and speed of genetic engineering with the efficiency of single-use disposable technol…
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Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
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The Affordable Care Act's Impact on Innovation in Biopharma
Despite this spending increase, Americans’ average life expectancy and the efficiency of the US healthcare system are ranked near the bottom of countries with advanced economies (2). These cost increa…
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EMA Collaborates with HTA Assessment Networks
Important to the success of Glybera will be the efficiency of the process at its Amsterdam plant for producing gene cassettes for delivering transgenes into the body’s cells. Chiesi’s strategy is to o…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…