Search results for " drug" in Articles / App Notes
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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 …
Article
The New World of Biopharmaceutical Manufacturing
Companies are implementing end-to-end single-use platforms for monoclonal antibody, antibody drug conjugate, and vaccine production. Flexible facilities are likely to become an important part of large…
Article
Being Thorough When Transferring Technology
During tech transfer, methods, skills, technologies, and importantly, knowledge is transferred from the drug developer to another site or group, often a contract manufacturing organization (CMO). It’s…