Simply addressing these risk factors as part of product development will not eliminate immunogenicity. Preclinical studies are not yet capable of assessing the clinically relevant immunogenicity potential of these product-related factors. Aggregation carries the greatest concern as a risk factor for immunogenicity, but the impact of aggregates is likely to depend on their structure as well as on the functionality (e.g., immunostimulatory or immunomodulatory) of the therapeutic. No report could be found that clearly de-convolutes the clinical impact of the product attributes on patient susceptibility. However, a critical examination of the available data shows that clear unequivocal evidence for the impact of these latter factors on clinical immunogenicity is lacking. Product-related factors such as the molecule design, the expression system, post-translational modifications, impurities, contaminants, formulation and excipients, container, closure, as well as degradation products are all implicated. Several factors, including patient characteristics, disease state, and the therapy itself, influence the generation of an immune response. Setting the standard for biopharmaceutical education in the 21st century, this title complements and is cross-referenced to the latest editions of the three major pharmacotherapy textbooks used by pharmacy schools in North America – linking the pharmaceutical aspect of biotechnologically derived drugs with their pharma-cotherapeutic application for easy integration into existing curricula…discusses general concepts in the production, and clinical pharmacology of monoclonal antibodies, as well as their therapeutic application in cancer treatment, immuno-suppressive therapy related to organ transplantation, and anti-inflammatory therapy…describes regulatory requirements of biotechnology drug products to receive approval to market… presents challenges and approaches for overcoming an undesired immune response to protein therapeutics… addresses the discovery and clinical development of the new biotechnology-produced drugs.Īll protein therapeutics have the potential to be immunogenic.
#BIOTECHNOLOGY BY R.C.DUBEY PDF PROFESSIONAL#
A chapter containing self-assessment questions has also been added to reinforce understanding of practical pharmaceutical applications, making this an indispensable volume for classroom use, as well as a professional reference used within the clinic or pharmaceutical industry. New chapters cover evolving areas regarding biopharmaceuticals, including oligonucleotides, siRNA and various monoclonal antibodies, immunogenicity, gene therapy, and the regulatory issues factoring into the biopharmaceutical approval process. This Third Edition provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, including drug development, production, dosage forms, indications, administration, and therapeutic developments. NC nM nY nK about the book… Educators and students will benefit from a completely revised text that reflects the emergent trends and cutting-edge advances in pharmaceutical biotechnology.
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