Search results for " therapeutic"
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
On the smaller scale, Masser also notes that scrutiny by FDA and internal quality control becomes more intense the closer a process step is to the final therapeutic, and as a result there have histori…
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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
• Invest in targeted therapeutics/personalized medicine based on biomarkers with the goal of drug-diagnostic companions with the ability to demonstrate high value in small subsets of the population.
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EMA Collaborates with HTA Assessment Networks
…ders (KOLs), mainly comprise appraisals of clinical trial data to ensure that a medicine gives added therapeutic value. But they are also starting to cover types of formulation and manufacturing proc…
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2014 Manufacturing Trends and Outlook
About 20% said capacity was added due to the acquisition of another company or in-licensing of a drug product
Almost 45% of the respondents reported that their organizations manufacture therape…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Continuum of CQAs
Prior to the development of a new drug, companies frequently decide and document a therapeutic need in the marketplace for a new pharmaceutical. It is through this effort that th…
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Climate Change in Outsourcing
Announcements of plant and laboratory closures, layoffs, and narrowed therapeutic focus still occur almost monthly, and it doesn’t look like they will end any time soon.
In recent years, the globa…
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Trends in Downstream Bioprocessing
Downstream processing involves the recovery and purification of protein therapeutics for biopharmaceuticals, vaccines, and other biologics. It involves the removal of insoluble cell debris and parti…
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Operational Excellence: More Than Just Process Improvement
The pressures are many and relentless: price constraints, global competition, product complexity, and more challenging therapeutic areas. In response, many companies have embarked on operational excel…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
…s should be considered as a major risk reduction factor with respect to the safety of plasma derived therapeutic proteins.
Perhaps one of the next focus areas in product safety will be how to bet…