Progress in the use of biological assays during the development of biotechnology products

Pharmaceutical Research

Volumn 18, Issue 9, 2001, Pages 1239-1246

  Mire Sluis, A R ^a  

^a GENENTECH INC   (United States)

Author keywords

Analytical; Biological assays; Biotechnology; Immunogenicity; Therapeutics

Indexed keywords

DRUG; NEUTRALIZING ANTIBODY;

BIOASSAY; BIOSENSOR; BIOTECHNOLOGY; DRUG ANTIGENICITY; DRUG DETERMINATION; DRUG SCREENING; ENZYME ACTIVATION; IMMUNOGENICITY; NONHUMAN; PRIORITY JOURNAL; RECOMBINANT DNA TECHNOLOGY; REPORTER GENE; REVIEW;

ALLERGY AND IMMUNOLOGY; ANIMALS; BIOLOGICAL ASSAY; BIOTECHNOLOGY; DRUG DESIGN; HUMANS; PHARMACOLOGY;

EID: 0034840942     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1013067424248     Document Type: Review

References (41)

1. Biological assays: Their role in the development and quality control of recombinant biological medicinal products
2. The use of bioassays for the characterisation and control of biological therapeutic products produced by biotechnology
3. Challenges with current technology for the detection, measurement and characterization of antibodies against biological therapeutics
4. The biological characterization and assay of cytokines and growth factors
5. ICH Topic Q6b. Specifications: Test procedures and acceptance criteria for biotechnological/biological products
6. Quantitative biological assays for individual cytokines
7. Cytokines - Protein structure and biological activity: A complex relationship with implications for biological assays and standardisation
8. ICH Topic Q 2 A. Validation of analytical methods: Definitions and terminology
9. ICH Topic Q 2 B. Validation of analytical procedures: Methodology
10. The development of non-animal based bioassays for cytokines and growth factors
11. The peripubertal male rat assay as an alternative to the Hershberger castrated male rat assay for the detection of anti-androgens, oestrogens and metabolic modulators
12. Quality considerations for recombinant DNA-derived biological therapeutic products
13. Bioassays of gonadotrophins
14. Biological assays for haematopoietic growth factors
15. Laboratory protocols for the quantitation of cytokines by bioassay using cytokine responsive cell lines
16. Luciferase reporter gene assay in mammalian cells
17. A sensitive and versatile bioassay for ligands that signal through receptor clustering
18. Quantitative analysis of gene expression with an improved green fluorescent protein, p6
19. Use of a dual firefly and Renilla luciferase reporter gene assay to simultaneously determine drug selectivity at human corticotrophin releasing hormone 1 and 2 receptors
20. Correct evaluation of reporter gene assays in different cell lines by direct determination of the introduced plasmid amount
21. Control and statistical analysis of in vitro reporter gene assays
22. Analysis of neurotrophin/receptor interactions with a gD-flag-modified quantitative Kinase Receptor Activation (gD.KIRA) enzyme linked immunosorbant assay
23. Kinase receptor activation (KIRA): A rapid and accurate alternative to end-point bioassays
24. ELISA methods for the analysis of antibody responses induced in multiple sclerosis patients treated with recombinant interferon-beta
25. BIACORE: An affinity biosensor system for characterization of biomolecular interactions
26. Applications for the new electrochemiluminescent (ECL) and biosensor technologies
27. Mapping and characterization of the epitope(s) of Sch 55700, a humanized mAb that inhibits human IL-5
28. A fully human antibody neutralising biologically active human TGF-beta 2 for use in therapy
29. Validation parameters for a novel biosensor assay which simultaneously measures serum concentrations of a humanized monoclonal antibody and detects induced antibodies
30. Development and application of surface plasmon resonance-based biosensors for the detection of cell-ligand interactions
31. Detection and characterization of antibodies to peg-IFN-alpha2b using surface plasmon resonance
32. Expression of potency: Why units of biological activity not mass?
33. Facilitating the development of cytokines in research and as therapeutic agents: The WHO Cytokine Standardisation Programme
34. Evaluation of assay designs for assays using microtitre plates: Results of a study of in vitro bioassays and immunoassays for tumour necrosis factor
35. Validation of a rat pheochromocytoma (PC12)-based cell survival assay for determining biological potency of recombinant human nerve growth factor
36. Statistical analysis of results of biological assays and tests