Search results for " biopharms"

Article Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments. Following the 2009 outbreak of the H1N1 pandem…

Article Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle. With the most recent FDA …

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…

Article Operational Excellence: More Than Just Process Improvement
By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work. Life-sciences companies face more pressure than ever to reduce costs and increase eff…

Article Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends. With the dawn of the 2…

Article Welcome to the new Process Development Forum
August 15, 2013 Welcome to the new Bioprocess Development Forum (PDF) website. We launched www.ProcessDevelopmentForum.com two years ago as a new channel for information relevant to research…

Article Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results. By: Simon Chalk BioPharm International There is a high degree of consensus in the biomanuf…

Article Quality Considerations for Using AI in Bio/Pharma
The use of artificial intelligence (AI) is seeing a surge in a variety of industries. But does the regulated nature of bio/pharmaceutical development, manufacturing, and commercialization ser…

Article Downstream Process Developers: What are Your Antibody Processing Challenges?
Process developers, we want to hear from you! We're asking PD scientists to tell us about their biggest challenges developing downstream processes for mAbs and their variants.  Take this …

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