Search results for " formulation" in Articles / App Notes
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Furthermore, adjuvant-related adverse reactions are not an issue with this technology, and cellular responses are promoted because no adjuvants are used in the vaccine formulations.
The major t…
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The Affordable Care Act's Impact on Innovation in Biopharma
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
The Affordable Care Act (ACA) has elicited intense national debate and sent biopharm…
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EMA Collaborates with HTA Assessment Networks
But they are also starting to cover types of formulation and manufacturing processes particularly when gauging cost effectiveness. National bodies do not always carry out assessments but they are also…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
They should cover the whole formulation, including excipients and diluents because of their effect on the medicine’s safety and efficacy. A similar procedure was suggested for dealing with the issue o…
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Biotechnology Innovation and Growth in Israel
Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.
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Elucidating Biosimilars Characterization
While batches of drug product are often used, it should be considered that the formulation of the drug product may interfere in the subsequent comparability/similarity study and attempts to deformulat…
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The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
The following ar…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
These methods are among the most frequently used tests for lot release of drug substance and drug product,5 as well as during formulation and process development. Several multi-product analytical meth…
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Milestones and Moderate Progress in 2012 Drug Approvals
Zaltrap is approved for treatment of colorectal cancer, and the active ingredient is also marketed in a different formulation as Eylea, approved in 2011 for the treatment of age-related macular degene…
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Quality by design for biotechnology products—part 1
They include but are not limited to product-related variants, process-related impurities, formulation parameters, and essential attributes such as appearance. Examples of process-related impurities in…