Search results for " patients"
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Reviewing the Importance of Biosimilarity and Interchangeability
Immunogenicity of the biosimilar product is also assessed in patients who undergo repeated switching between the biosimilar and the reference product.
Clinical relevance of switching. Regulator…
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Maximum Output Starts with Optimized Upstream Processing
“This approach has enabled us to adjust much of our internal manufacturing activities to maximize our ability to produce REGEN-COV while still ensuring patients get the other FDA-approved Regeneron me…
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Genetic Vaccine Platforms Demonstrate Their Potential
Bleck adds, however, that the new vaccines still need to be evaluated in detailed clinical studies to confirm that the new mutated epitopes do not elicit unwanted immune responses in patients.
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Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Cells collected from patients with illness display significant physiological differences compared to those collected from healthy donors. Cell subset composition, cell phenotype expression, and the pr…
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Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
In addition, given that autologous cell therapy products often lead to a single dose for patients with limited treatment options and time, redundancy in manufacturing capability to proactively mitigat…
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Biosimilars to Drive Modern Manufacturing Approaches
As new biosimilars emerge for patients, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), is emphasizing the importance of building public trust in biosimilar safety and …
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Biopharma Advances Demand Specialized Expertise
This requires a robust integrated supply chain to deliver high value products to patients, on-time and at the right quality. Doing this reliably and efficiently with long production lead times and unc…
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Biosimilars Development and Supply: How Complex Can the Process Be?
High-quality, reliably supplied biosimilars offer additional therapeutic choices to patients and other key stakeholders; however, development and supply of these complex medicines are scientifically c…