Search results for " market" in Articles / App Notes
Article
Taking a “Development-by-Design” Approach to Cell Therapies
More CDMOs are entering cell therapy market niche
Demand for specialized cell therapy manufacturing and development services is also growing, and has attracted Lonza Bioservices, Cognate BioServic…
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Drug Discovery and Development in India
India registers a low score on BMI’s Pharmaceutical Risk/Reward Index (RRI)’s measure of Patent Respect (an index providing a globally comparative and numerically based assessment of a market’s attrac…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
The very nature of aggregation is challenging, says St John Skilton, senior global market manager of biologics at SCIEX, a life-science analytical technologies company. The fact that aggregation is “d…
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What Drove Biopharma Development in 2014?
And while QbD may be a federal requirement, the technique has emerged as a tangible tool to speed time to market, reduce recalls and rejects, minimize post-approval changes, streamline data flows acro…
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Manufacturers Struggle with Breakthrough Drug Development
Chemistry, manufacturing, and control (CMC) issues are not considered at this point, although they are important for the product to come to market. Consequently, FDA officials urge manufacturers with …
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Early Communication with Regulators is Essential for SMEs
…s, evaluation, and above all, scientific advice that can raise the chances of a new medicine gaining marketing approval.
The importance of early dialogue with regulators
Companies a…
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Climate Change in Outsourcing
…e gains on their bio/pharmaceutical companies’ investments and encouraged investors to reenter the market.
Rising opportunities
As these forces reshape the bio/pharmaceutical industry, they a…
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Bioprocessing Advances in Vaccine Manufacture
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few major, long-established players that primarily manufacture aging, long-marketed, non-recombinant (nonge…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
The industry needs to be prepared to also serve these markets with new business models and novel manufacturing processes. Most likely beyond the more classical Cohn derived processes. Julie Kim also p…
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Prescribing Caution for Biosimilars
They are also a necessary measure to ensure that patients and their physicians remain in control of their medical treatment decision-making as the market for complex biologics evolves over the next se…