Search results for " market"
Article
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…
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The Lifecycle Change of Process Validation and Analytical Testing
Reliance on complex and sophisticated sales algorithms in the stock market is an example of this type of error. On the other hand, humans can make simple errors. Therefore, finding a balance between r…
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The Future of Biopharma
The current situation in the biopharmaceutical industry is exciting enough, with biosimilars, new technologies, personalized medicines, and opportunities in emerging markets. The industry, however, be…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“First of all, there is the 12-year data exclusivity period which means that a biosimilar product in the US cannot come to market until 12 years after the reference product or innovator product was fi…
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Reviewing the Importance of Biosimilarity and Interchangeability
However, bringing a biosimilar to market has strict challenges because the biosimilar developer must have a large set of analytical similarity data compared to the innovator biologic. In addition, the…
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Developing oligonucleotide therapeutics with confidence
You will learn about:
• the oligonucleotide therapeutic market
• the therapeutics in development
• challenges you may face and key considerations to address those challenges
• how to …
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Principles of Cell Line Development
It also takes a closer look at where it fits into this wider process including:
Overall path to market
Key processes and methods
Tools and equipment
Key regulatory re…
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Innovative Chromatography Resins Can Improve Purity and Quality
Ongoing downstream challenges
Constraints still remain in downstream processing of mAbs, which continue to be the most successful segment of biological molecules in the market in terms of required…