Search results for " market"
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Continuous Manufacturing: A Changing Processing Paradigm
While only a few approved biologic products in the market—less than 10%, according to estimates by Eric Langer, managing partner, BioPlan Associates—are manufactured through perfusion or continuous do…
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Setting Standards for Biotech Therapeutics in India
The biopharmaceuticals market has witnessed the fastest growth in the 2013 financial year as compared to other biotech markets (e.g., Bio-Agri, Bio-Services, and Bio-Informatics).
Growth in this s…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
Many of the largest branded biotech products in the US market today are now in biosimilar development by at least one company, Levesque says, and the pipeline is expanding. Blockbuster biotechs facing…
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Flexibility in Biopharmaceutical Manufacturing
This takes operational flexibility to a different level and provides options when capital investment is at risk because of marketing forecast changes and approval uncertainty. Long construction and st…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
There are three different types of flu vaccines on the market: split virus, subunit vaccines, and live attenuated. Live, attenuated influenza vaccine (LAIV) requires less virus particles per vaccine d…
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Advancing QbD in the EU
"But the regulatory adoption of the guidelines is clarifying what elements are considered essential to support the pharmaceutical development section of a marketing authorization application dossier."…
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Bracing for a Future Wave of Advanced Therapies
As a result, both regulatory and industry are strengthening their relationship with the goal of preparing the US healthcare market for the entrance of these new products.
State of the industry
…
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Maximum Output Starts with Optimized Upstream Processing
…rely on the manufacturing capacity, expertise, and flexibility of CDMOs to bring their candidates to market. “With most of the drug development pipeline being held by these emerging and small biotech…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
… sufficient capacity and removing the need for process change, says Marie Jourdan, vice-president of marketing and product management at Univercells Technologies.
The well-known limitations of fl…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
What are some key guidelines for biopharma companies to follow?
Steven Lynn: I think, first off, it depends on where the company is manufacturing and marketing their products. From the US persp…