Search results for " drug"
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
The need for harmonized standards was emphasized, but lacking any immediate consensus, the panelists recommended that drug companies take a risk-based approach to evaluating single-use system componen…
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Technologies and Practices Must Evolve to Meet Demand
3, 2014, nearly 30% of FDA’s new drug approvals for 2014 were for biologic-based therapies, up from 7% in 2013 (1). As the percentage of large-molecule drugs grows, bioprocessing capabilities must kee…
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Single-Domain Antibodies for Brain Targeting
Immunogenicity concerns in relation to these strategies are still under investigation by drug regulatory agencies. Favorable properties, such as good expression, thermal stability, and solubility, are…
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Challenges in Analytical Method Development and Validation
Analytical testing can provide the data needed to produce a safe and effective drug product. The development and validation of analytical methods is crucial in drug development. While the biopharmaceu…
Article
Predicting Progress in Protein Aggregation
…pectrometry (HDX MS), are enabling the improved design, production, and formulation of protein-based drugs. As the development of biologic drugs based on antibodies and other protein/peptide molecule…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. Ther…
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Sterilization Trends for Single-Use Consumables
Several sterilization process essentials
Contamination poses a huge risk to the production of biologic drug substances and drug products, making sterility assurance imperative, states Christy Eatmon…
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Virus-like Particles as Therapeutic Moieties of the Future
Further, drug molecules such as anticancer drugs, Adriamycin (doxorubicin hydrochloride), and aleomycin can also be loaded and delivered to target cell types (3,4). Encapsulation of drug molecules wit…
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Using Software in Process Validation
Software systems have become instrumental as validation expands from analytical methods used for the quality control of drug substances and drug products to computerized systems for clinical trials, l…
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Tools and Processes for Mature and Emerging Therapies
By Rita Peters
Conference sessions and new technology introductions at recent trade shows addressed ongoing and emerging trends in the development and manufacture of biologic-based drugs. While …