Search results for " efficacy"
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
…ssible to predict that any differences in quality attributes have no adverse impact on the safety or efficacy of the drug product (16). Manufacturing changes may be frequent and approval times for ch…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
Challenges with traditional vaccines
Traditional vaccines have a long track record of safety and efficacy. They have been shown, according to Charles Christy, head of com…
Article
The Importance of Partnering for Bioanalytical Studies
…rs, which are used to guide decisions on how often and how much of a therapeutic should be given for efficacy without undue toxicity.
Bioanalytical assays extend beyond simply measuring drug c…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Apheresis center capacity, donor network access, sample handling expertise, and quality control systems all contribute to the ability to achieve reproducible starting material quality and efficacy.
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Article
Impurity Testing of Biologic Drug Products
“Historically, contamination with trace amounts of metals was a problem leading to aggregation of therapeutic proteins, which can cause significant changes in efficacy, but understanding of the phenom…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…Pharmaceuticals for Human Use (ICH) Q6B (8), and could have potential implications on the safety and efficacy of the intended products. In addition, the integrated transgenes may be partially or comp…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Immunogenicity and efficacy
High levels of aggregates can reduce therapeutic efficacy of a biologic, or impair product quality or stability. This could increase the risk of an immunogenic response…
Article
The Bullish Outlook for Biosimilars
…just recently approved and implemented stricter regulatory guidelines that put a greater emphasis on efficacy and safety (6).
In contrast to these other markets, the United States has surprisin…
Article
Elucidating Biosimilars Characterization
…portant with regard to the structure-function relationship of the molecule, or whether for safety or efficacy purposes, it may be necessary to engineer out the modified amino acid.
Similarly for …
Article
Emerging Therapies Test Existing Bioanalytical Methods
Specialty assays used to understand the distribution, function, efficacy, and immunogenicity of gene- and cell-therapy drugs—including cell-based neutralizing assays, qPCR, flow cytometry and enzyme-l…