Mr DNA
International Standardization of Biological Drugs Used in Gene Therapy Treatments. DE
Seiten
2025
Editions Notre Savoir (Verlag)
978-3-330-51238-2 (ISBN)
Editions Notre Savoir (Verlag)
978-3-330-51238-2 (ISBN)
- Titel nicht im Sortiment
- Artikel merken
The manufacture of biological active substances and medicinal products involves certain specific considerations dictated by the nature of these products and the processes used. The methods by which biological medicinal products are manufactured, controlled and administered require certain special precautions. Unlike conventional medicinal products, which are manufactured using physical and chemical techniques capable of a high degree of reproducibility, the manufacture of biological active substances and medicinal products involves biological processes and materials such as cell culture or extraction from living organisms. These biological processes may have inherent variability, so that the range and nature of by-products may vary. The principles of quality risk management (QRM) are therefore particularly important for this class of materials, and must be applied to develop a control strategy during all stages of manufacturing, so as to minimize variability and reduce the risk of contamination and cross-contamination.
Abdoul Hamid Derra - Information systems engineer, entrepreneur, researcher, strategic studies developer, education advisor, maternal-child health, nutritionist.
| Erscheinungsdatum | 19.04.2025 |
|---|---|
| Sprache | englisch |
| Maße | 150 x 220 mm |
| Gewicht | 745 g |
| Themenwelt | Medizinische Fachgebiete ► Radiologie / Bildgebende Verfahren ► Kernspintomographie (MRT) |
| Medizin / Pharmazie ► Studium | |
| Schlagworte | Active Substance • Active Substance Gas • adjuvant • Allergoids • antibodies • Antigens • application • Armored Enclosures • biological drugs • Biosafety level • Blinding • Blood Component • Blood Transfusion Establishment • Bottle Frames • bottles • Campaign Manufacturing • Cell Bank • Cell Storage • change control • check valve • clinical trial • Compressed Gas • Confirmation • Critical Process Parameter • Critical Quality Characteristics • cryogenic gas • Design space • Drug Specification File • Drug Used As Reference • excipients • experimental drug • experimental medicines • Ex vivo • Factor Agents • Feed Cells • Finished Product Batch Certification • Fractionation Laboratory • Gas • Gene • Genetically modified organism • Hapten • Hot Cells • Human Blood or Plasma Derived Drug • Hybridome • Hydraulic Test • Importer • Insulation • investigator • In vivo • IT Infrastructure • knowledge management • Life Cycle • Liquefied gas • Manufacturer/Importer • Manufacturing • Matrix or Framework Approach • Maximum Theoretical Residual Impurity • Medicinal Gas • Microbial Load • Mobile Tank • Mono Aseptic • monoclonal antibodies • Mother Cell Bank • Multi-Product Facility • Ordering • Parametric Release • Plasma for Fractionation • Plasma Master File • polyclonal antibodies • Preparation • Process owner • Qualified Person • Quality Risk Management • Randomization Code • Responsible Person • shipping • Somatic Cells • Specifications • Specified Pathogen Free • Surveillance Status • System Owner • traditional approach • Voluntary Release • Working Cell Bank |
| ISBN-10 | 3-330-51238-5 / 3330512385 |
| ISBN-13 | 978-3-330-51238-2 / 9783330512382 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
| Haben Sie eine Frage zum Produkt? |
Mehr entdecken
aus dem Bereich
aus dem Bereich
Lehrbuch und Fallsammlung zur MRT des Bewegungsapparates
Buch | Hardcover (2020)
mr-verlag
CHF 306,55
