Navigation Links
Reportlinker Adds Immunogenicity to Biologics
Date:11/3/2010

e collected for immunogenicity assessments? 4.10. Reporting of clinical immunogenicity results

5. Post-marketing immunogenicity commitments

6. References

Chapter 6 Regulatory Recommendations when dealing with the FDA

Dr Bonita Rup, Senior Director, Bioanalytical R&D, Drug Safety and Metabolism, Wyeth Research, USA

1. Recent White Papers on development, validation and implementation of immunogenicity testing and on risk assessment 1.1. Background to the papers, why produced, which companies and people made recommendations, their significance to the industry. 1.2. Recommendations for the design and optimisation of immunoassays 1.3. Report on neutralising antibody white paper 1.4. What is the benefit of the FDA-requirement for neutralising assays in phase II (they are difficult to develop and are only relevant at phase III) 1.5. Report on validation of immunoassays 1.6. Report on risk based strategies 1.7. Advice on methods to use for specific products 1.8. Sensitivity of screening assays 1.9. Dealing with low-affinity antibodies 1.10. Evaluation of drug interference 1.11. Confirmatory assays required: how effective are they as a predictive marker? 1.12. Immunogenicity method validation 1.13. Interpretation of the results: How do they correlate with the clinical outcome? 1.14. Assays for T-cell activation

2. Practical advice on dealing with the regulators at the various stages of development 2.1. Experiences of the industry 2.2. When to design the immunogenicity programme 2.3. Advice on selection of assays for the type of product 2.4. Acceptable levels of assay sensitivity 2.5. Ensuring assay results are not questionable 2.6. Proper validation and characterisation of assays 2.7. Requirements before going into patients 2.8. Validation for each stage 2.9. Amount of pre-clinical and clinical immunogenicity data required 2.10. Advice on dealing with impurities with host cell protein 2.11. How much information is enough an
'/>"/>

SOURCE Reportlinker
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related biology technology :

1. Reportlinker Adds Infectious Disease Molecular Diagnostic Testing
2. Reportlinker Adds Smart Glass: Technologies and Global Markets Report
3. Reportlinker Adds Synthetic Biology: Emerging Global Markets Report
4. Reportlinker Adds Proteomics: Technologies and Global Markets Report
5. Reportlinker Adds Nanomedicine Report
6. Reportlinker Adds Small Molecule Kinase Inhibitors Report
7. Reportlinker Adds Nanoporous Materials Report
8. Reportlinker Adds Membrane Bioreactors Report
9. Reportlinker Adds The Future of Orphan Diseases Therapeutics - Market Forecasts to 2015, Pipeline Analysis and Reimbursement
10. Reportlinker Adds High-Tech Patient Monitoring Systems Markets (Remote and Wireless Systems, Data Processing, EMR Data Transfer) Report
11. Reportlinker Adds In Vitro Diagnostics in a Recession: IVD Market Forecasts, Analysis and Success Strategies Report
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/19/2014)... October 19, 2014 The Asia-Pacific Speech ... market in Asia-Pacific with analysis and forecast of revenue. ... in 2014 to $208 million by 2019, at a ... to 2019. , Browse through the TOC of the ... of the in-depth analysis provided. It also provides a ...
(Date:10/19/2014)... (PRWEB) October 19, 2014 According ... Products (Access Points; WLAN Controllers; Wireless gateways)]- Global ... and segments the global Outdoor Wi-Fi market with ... this report MarketsandMarkets also identifies the drivers and ... on the trends, opportunities and challenges. , Browse ...
(Date:10/18/2014)... October 18, 2014 The Asian arthroscopic ... Asia with analysis and forecast of revenue. The arthroscopic ... $712.3 million by 2018, at a CAGR of 6.5% ... of the Asian arthroscopic devices market, to get an ... a glimpse of the segmentation of arthroscopic devices market ...
(Date:10/18/2014)... 18, 2014 The Biomass Power ... the five years to 2014. The industry's expansion has ... tax credits that encouraged the use of biomass power. ... standards (RPSs), which require local utilities to generate electricity ... energy portfolio. Increased campaigning for green technology also influenced ...
Breaking Biology Technology:The Asia-Pacific Speech Analytics market is estimated to reach $208 million by 2019 - New Report by MicroMarket Monitor 2The Asia-Pacific Speech Analytics market is estimated to reach $208 million by 2019 - New Report by MicroMarket Monitor 3The Asia-Pacific Speech Analytics market is estimated to reach $208 million by 2019 - New Report by MicroMarket Monitor 4Outdoor Wi-Fi Market (by Access Points, WLAN Controllers, Wireless gateways) Expected to Cross $37.2 Billion by 2018 - New Report by MarketsandMarkets 2Outdoor Wi-Fi Market (by Access Points, WLAN Controllers, Wireless gateways) Expected to Cross $37.2 Billion by 2018 - New Report by MarketsandMarkets 3Outdoor Wi-Fi Market (by Access Points, WLAN Controllers, Wireless gateways) Expected to Cross $37.2 Billion by 2018 - New Report by MarketsandMarkets 4The Asian arthroscopic devices market is estimated to grow to $712.3 million by 2018 - New Report by MicroMarket Monitor 2The Asian arthroscopic devices market is estimated to grow to $712.3 million by 2018 - New Report by MicroMarket Monitor 3The Asian arthroscopic devices market is estimated to grow to $712.3 million by 2018 - New Report by MicroMarket Monitor 4Biomass Power in the US Industry Market Research Report from IBISWorld Has Been Updated 2Biomass Power in the US Industry Market Research Report from IBISWorld Has Been Updated 3
... Molecular Assays Should be Considered as an Adjunct to Standard ... GENEVA, and REDWOOD CITY, Calif., June 26 Genomic Health, ... St. Gallen International Consensus Panel on the Primary Therapy of ... multigene assays, such as Onco type DX(R), should be ...
... ... ... today announced it has made two cotton acquisitions in India to enhance its product ... purchased the cotton seed business of Nandi Seeds, based in Mehboob Nagar, Andhra Pradesh, India, ...
... , PALO ALTO, Calif., June 25 Varian Medical ... it has acquired the assets of Houston-based IKOEmed and ... of radiotherapy and radiosurgery treatments. The acquisition enables Varian ... to automate and accelerate the most time-consuming portion of ...
Cached Biology Technology:Genomic Health Reports Favorable Commentary on Value of Multigene Assays From the St. Gallen Expert Consensus Meeting on the Primary Treatment of Early Breast Cancer 2Genomic Health Reports Favorable Commentary on Value of Multigene Assays From the St. Gallen Expert Consensus Meeting on the Primary Treatment of Early Breast Cancer 3Genomic Health Reports Favorable Commentary on Value of Multigene Assays From the St. Gallen Expert Consensus Meeting on the Primary Treatment of Early Breast Cancer 4Genomic Health Reports Favorable Commentary on Value of Multigene Assays From the St. Gallen Expert Consensus Meeting on the Primary Treatment of Early Breast Cancer 5DuPont Adds Cotton to India Seed Product Lineup 2DuPont Adds Cotton to India Seed Product Lineup 3DuPont Adds Cotton to India Seed Product Lineup 4Varian Medical Systems Acquires Assets of IKOEmed and IKOEtech; Acquisition to Add Software for Accelerating Radiotherapy Treatment Planning 2Varian Medical Systems Acquires Assets of IKOEmed and IKOEtech; Acquisition to Add Software for Accelerating Radiotherapy Treatment Planning 3
(Date:10/18/2014)... Berlin, 19th October 2014 Psychological stress and stress-related ... for aging-related diseases, but the molecular mechanisms ... mechanisms may contribute to the development of ... treatments for these devastating diseases. This work ... Neuropsychopharmacology congress in Berlin., Now an international ...
(Date:10/17/2014)... of Copenhagen have shown for the first time how ... fibrosis patients, giving them the opportunity to get tremendous ... , The study also discovered the bacterial growth in ... halted or slowed down by the immune cells. The ... and helped "suffocate" the bacteria, forcing the bacteria to ...
(Date:10/16/2014)... on how the bowel lining develops and, in the ... starts. , The researchers produced evidence that stem cells ... are a feature of the bowel lining, and believe ... a controversial finding as scientists are still divided on ... Dr Chin Wee Tan and Professor Tony Burgess from ...
Breaking Biology News(10 mins):Researchers find why depression and aging linked to increased disease risk 2Scientists opens black box on bacterial growth in cystic fibrosis lung infection 2Cryptic clues drive new theory of bowel cancer development 2
... Eight supply chain professionals were elected in June by the membership of ... existing members of SCC,s board. Newly elected board members, whose terms ... , , , , ... , Jane Barrett, Research Director, AMR ...
... , , LONDON, July 10 IBM (NYSE: ... executive agency of the UK Home Office, have signed a seven-year agreement ... upgrade to biometric passports and enhance the security of the UK border. ... (UKBA) Immigration and Asylum Fingerprint System (IAFS) which holds biometrics collected from ...
... On the heels of his discovery in Montana of ... paleontologist Anthony Martin has found evidence of more dinosaur burrows ... in Victoria, Australia. The find, to be published this month ... shared by dinosaurs of different species, in different hemispheres, and ...
Cached Biology News:UK Identity and Passport Service and IBM Sign 7-year National Biometric Identity Service (NBIS) Contract 2Down Under dinosaur burrow discovery provides climate change clues 2Down Under dinosaur burrow discovery provides climate change clues 3
... (Cap Analog) is used for the synthesis ... vitro transcription reactions. Substitution of cap analog ... in an in vitro transcription reaction results ... into a large fraction of the transcripts. ...
... Incubator/Shaker HT is designed for ... Incubator/Shaker HT is ideal for ... and primer extension assays. The ... as a one-cabinet model, allowing ...
... Incubator/Shaker HT is designed for ... Incubator/Shaker HT is ideal for ... and primer extension assays. iEMS ... a one-cabinet model, allowing the ...
... Source: Pseudomonas atlantica Description: Beta-Agarase ... RNA fragments from low-melting-temperature agarose. Beta-Agarase ... disaccharides. Tested User Friendly Properties: Heat ... 30,000 Da Optimum pH: 6.5 Purity: ...
Biology Products: