Search results for " market"
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Based on this forecast, the industry expects cell and gene therapy products to surge in the market and remain a prominent part of the pharmaceutical industry for years to come (2).
FDA has devel…
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Biosimilar Quality Requirements
…imilars and marks significant action taken by the agency to help promote competition in the biologic market. In May 2019, the agency published the draft guidance Development of Therapeutic Protein Bi…
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Driving Improved Access to Biosimilars
He suggested that biosimilar versions of insulin would be likely to reach the market over the next few years.
Almost a year after FDA formally issued its Biosimilars Action Plan (3), with the c…
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A Plastic Pipeline for Commercial Bioprocessing?
Pressure to get drugs to market faster, the smaller batch sizes characteristic of targeted therapies, and the comfort level biopharma companies and contract manufacturing organizations (CMOs) have wit…
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Industry Adoption of Single-Use Systems Remains Low
The market for single-use technology is growing, however, as capacity needs evolve.
Conservative attitude
Conservative attitudes tend to dominate the pharmaceutical and biop…
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Process Development: What May Lie Ahead in 2018?
Markets and Markets recently projected single-use bioreactors will be a $1.09-billion market by 2021 (up from $408.4 million in 2016), according to the same article.
In 2017, Process Development F…
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Patenting Prospects for Cell-Based Therapies
Indeed, it may be the case that regulatory exclusivity—analogous to the 12-year market exclusivities for biologic drugs provided by the Biologics Price Competition and Innovation Act (BPCIA)—will be m…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Therefore, a biophysical potency measurement plays a much bigger role in the biosimilar market as opposed to [the market for] the original molecule.”
Daniel Galebraith, who is chief scientific off…
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A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Similar to the single-use system advances, continuous manufacturing for the production of biologics is showing some step-by-step advances, but still trails advances on the small-molecule market.
I…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Alternatively, it should be possible to consider what quantity (in kilograms) of the bulk API needs to be produced for each product within the facility per year to meet clinical trial or commercial ma…