Search results for " efficacy"
Article
Bureaucratic Roadblocks Threaten Biopharma Growth
…e Court to deny patent protection for a novel therapy on the grounds it did not demonstrate enhanced efficacy. Furthermore, Brazil’s unprecedented review of patents by the health regulatory authority…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Cell-culture technology also enables more robust virus production, and therefore, the virus in the vaccine is more consistent and more closely resembles the seed strain, which leads to increased effic…
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EMA Collaborates with HTA Assessment Networks
First a drug has to be approved for its quality, safety, and efficacy by one or more regulatory authorities. This approval can be either by the central London-based European Medicines Agency (EMA) for…
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Brazil Emerges as Global Biopharm Collaborator
Brazil is also controlling the efficacy and safety of pharmaceutical products through market regulation.
According to Guimarães, considering government expenditures with health products, biophar…
Article
Climate Change in Outsourcing
…pt (POC) model, which calls for minimizing development efforts until there is evidence of safety and efficacy in human subjects. POC is leading to specialization in the CMC (chemistry, manufacturing,…
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Biotechnology Innovation and Growth in Israel
Key regulatory considerations
New drugs registered in Israel, including biologics, must meet European Union (EU) standard GMPs in terms of quality and efficacy to ensure public safety. In ad…
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Biosimilars Development and Supply: How Complex Can the Process Be?
Precision is so crucial that even small variations in the manufacturing process can potentially alter the medicine’s safety and efficacy (7). It takes significant expertise and experience to ensure a …
Article
QbD and PAT in Upstream and Downstream Processing
For mAbs, besides the afore-mentioned factors, concentration of critical nutrients has been known to affect the glycoxylation pattern of the product, thereby impacting product efficacy.
Vanden Boo…