Search results for " safety"
Article
Preclinical Evaluation of Product Related Impurities and Variants
Despite their success, the adoption of biotherapeutics is marred by issues around affordability as well as risks associated to the challenges in assessment of their safety and efficacy arising from th…
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Eliminating Residual Impurities Starts with a Strategic Plan
…reduce the amount of testing needed while still meeting regulatory requirements and ensuring patient safety. It does require, however, a thorough understanding of the process combined with appropriat…
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Labeling of Biosimilars
Instead, a biosimilar has to demonstrate similarity to the reference product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exerc…
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Critical Quality Attributes Challenge Biologics Development
While CQAs of small-molecule drugs can affect the purity, strength, drug release, and stability of a drug, the complex nature of biologics can create additional quality attributes that can affect the …
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Genetic Vaccine Platforms Demonstrate Their Potential
Alternatively, vaccines can be classified into live and non-live vaccines, which is important when considering safety profiles.
Traditional vaccines and viral subunit/proteins directly elicit …
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Updating Viral Clearance for New Biologic Modalities
… used to ensure virus removal are well established and their effectiveness has been confirmed by the safety record of the therapeutics they were used to manufacture, adds Darren Verlenden, head of Bi…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Biotech therapeutics, particularly complex products such as monoclonal antibodies (mAbs), can have numerous quality attributes that can potentially impact safety and/or efficacy of the product (2). Id…
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Elucidating Biosimilars Characterization
Thus, a classical randomized crossover design as used for small molecules is not appropriate on safety and logistics grounds. Such studies, therefore, are most likely to use a parallel-group design, i…
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Regulatory Challenges in the QbD Paradigm
The key steps for QbD implementation include: identification of the product attributes that are of significant importance to the product's safety or efficacy (i.e., target product profile and critical…
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A Look Ahead at BioPharma Manufacturing and Regulation
The most common definition of regulatory science is a discipline that creates new tools, standards, and approaches for use in assessing the safety, effectiveness, quality, and performance of products.…