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

2.8. Challenges with monoclonal antibodies and other biologic products

3. Interpretation of results 3.1. Selection of reference standards and controls 3.2. Determination of cut-points 3.3. How do you work out if your results are significant or not – are the detected neutralising antibodies relevant in vivo? 3.4. How do results correlate with efficacy? 3.5. How to generate positive controls 3.6. How to prepare a calibration serum for an ELISA 3.7. Quantification of results: mass units v. titres 3.8. Dealing with drug interference with antibodies

4. Validation of neutralising assays 4.1. What needs to be validated in each clinical phase including pre-clinical. 4.2. Ensuring detection of low affinity as well as high affinity antibodies

5. Characterisation of antigen/antibody response and isotype determination 5.1. What do the antibodies bind to? 5.2. How do you identify the isotype? 5.3. What are the benefits of this? 5.4. Secondary characterisation

6. Comments on US White paper and EU guidelines to date 6.1. Guidelines on presentation of data

6.2. Risk-based assessment

7. Case studies if possible 7.1. Challenges with monoclonal antibodies and other biologic products

Chapter 5 Evaluation of Immunogenicity for Preclinical and Clinical Investigations

Dr Ingrid Caras, Senior Director, Preclinical and Clinical Development Sciences, PDL BioPharma, Fremont, CA, USA 1. Introduction

2. Preclinical immunogenicity safety assessment 2.1. Other options for pre-clinical immunogenicity assessments

3. Pre-clinical studies in animals

4. Clinical immunogenicity issues 4.1. Immunogenicity risk assessment 4.2. Implication of immunogenicity for the clinical program 4.3. Significance of low level immune responses 4.4. Incorporation of assays into the clinical program 4.5. Phase 1 studies 4.6. Drug interference and study design 4.7. Endpoints 4.8. Validation 4.9. When and how often should samples b
'/>"/>

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:2/27/2015)... 2015 Bionomics Limited (ASX:BNO, ADR:BMICY) is to ... BNC105 in patients with metastatic renal cancer at the ... . The data will be presented by Dr. ... Comprehensive Cancer Center in California ... data identifies Ferritin and IL-8 as two baseline biomarkers ...
(Date:2/27/2015)... South San Francisco, CA (PRWEB) February 27, 2015 ... it is joining forces on February 28 with patients ... globally to raise awareness for Rare Disease Day®. ... of rare diseases and calling attention to the special ... support community around them. , “Cytokinetics is proud to ...
(Date:2/26/2015)... NEW YORK , Feb. 26, 2015 ... commenced Factual Stock Report coverage on MabVax Therapeutics ... Inc. (MBVX) is a clinical stage biotechnology company focused ... address unmet medical needs in the treatment of cancer. ... products based on the protective immune responses generated by ...
(Date:2/26/2015)... - SQI Diagnostics Inc. ("SQI" or the "Company") (TSX-V: ... and commercializes proprietary technologies and products for advanced microarray ... the fiscal first quarter ended December  31, 2014. All ... (CAD), unless otherwise stated. "During the ... our existing customers and add to our sales pipeline," ...
Breaking Biology Technology:New BNC105 Biomarker Data to be Presented at US Cancer Conference 2New BNC105 Biomarker Data to be Presented at US Cancer Conference 3New BNC105 Biomarker Data to be Presented at US Cancer Conference 4New BNC105 Biomarker Data to be Presented at US Cancer Conference 5Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases 2Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases 3Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases 4Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases 5Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases 6S&P Capital IQ Initiates Coverage on MabVax Therapeutics Holdings Inc. in S&P Capital IQ Factual Stock Reports 2S&P Capital IQ Initiates Coverage on MabVax Therapeutics Holdings Inc. in S&P Capital IQ Factual Stock Reports 3S&P Capital IQ Initiates Coverage on MabVax Therapeutics Holdings Inc. in S&P Capital IQ Factual Stock Reports 4S&P Capital IQ Initiates Coverage on MabVax Therapeutics Holdings Inc. in S&P Capital IQ Factual Stock Reports 5SQI Diagnostics Reports First Quarter Financial Results 2SQI Diagnostics Reports First Quarter Financial Results 3SQI Diagnostics Reports First Quarter Financial Results 4SQI Diagnostics Reports First Quarter Financial Results 5SQI Diagnostics Reports First Quarter Financial Results 6
... March 3-9, SAN CARLOS, Calif., March 4 ... According to the National Sleep,Foundation,s Sleep in America poll, ... interest in sex because of sleepiness due to working,an ... per week at home. Many,may also suffer from Obstructive ...
... quality, on-demand content for medical ... ... Healthcare professionals who use,Advanstar,s ModernMedicine.com will experience enhanced Web search ... the medical professional,s search engine.,ModernMedicine.com is an innovative, online clinical ...
... FRANCISCO, Calif., March 4 Sunesis,Pharmaceuticals, Inc. (Nasdaq: ... anticancer therapeutics, will present data at the,upcoming 39th ... Society of,Gynecologic Oncologists (SGO). This year,s conference will ... Center in Tampa, Fla., Interim data from ...
Cached Biology Technology:SleepQuest Raises Awareness of Sleep Disorders 2Partnership With SearchMedica.com to Enhance Web Searches on ModernMedicine.com 2Partnership With SearchMedica.com to Enhance Web Searches on ModernMedicine.com 3Sunesis Pharmaceuticals to Present Interim Phase 2 Data for SNS-595 at the 39th Annual Meeting on Women's Cancer 2
(Date:2/5/2015)... TRIANGLE PARK, North Carolina , 5. ... sein 35. Jahr als spezialisiertes Logistikunternehmen und ... Position als einzige klinische Logistikfirma (Clinical Logistics ... Die Kernbotschaft der neuen Kampagne lautet ... und Lieferungen. Foto: http://photos.prnewswire.com/prnh/20150205/173753 ...
(Date:2/5/2015)... 26, 2015   Epic Sciences , a precision diagnostics ... that Murali Prahalad , Ph.D., president and CEO, is ... (PMWC) 2015: Silicon Valley, which is taking place at ... on January 26-28, 2015. Dr. ... as Biomarkers." Last year, Epic Sciences was a finalist in ...
(Date:2/5/2015)... IRVINE, Calif. , Jan. 27, 2015 ... trusted provider of globally deployed, innovative test ... today announced the delivery of its ... Martin Space Systems Company (LMSSC). GENASYS is ... the demands of mission-critical applications that require ...
Breaking Biology News(10 mins):Marken startet Kampagne mit Patienten im Mittelpunkt 2Marken startet Kampagne mit Patienten im Mittelpunkt 3Epic Sciences to Present at Personalized Medicine World Conference 2015 on the Use of Circulating Tumor Cells as Cancer Biomarkers 2Marvin Test Solutions' GENASYS Platform Advances Mission-Critical Aerospace Production Test 2Marvin Test Solutions' GENASYS Platform Advances Mission-Critical Aerospace Production Test 3Marvin Test Solutions' GENASYS Platform Advances Mission-Critical Aerospace Production Test 4
... University of Colorado at Boulder indicates biologists trying to ... the past several decades through hatchery propagation and restocking ... fish. According to a sophisticated DNA analysis, five ... be greenback cutthroat trout living in isolated pockets of ...
... Neurons, or nerve cells, communicate with each other ... damaged, communication breaks down, causing the messages that would ... our mind locate our car keys to fall short. ... at Chapel Hill School of Medicine have shown that ...
... Initiative, has signed a $7.8 million, two-year contract with ... establish a collection of DNA samples for autism studies. ... have a single autistic child. The Simons Simplex ... core resource for a new and different line of ...
Cached Biology News:New study shows greenback cutthroat trout involved in recovery effort misidentified 2New study shows greenback cutthroat trout involved in recovery effort misidentified 3Specific brain protein required for nerve cell connections to form and function 2Rutgers Genetics receives $7.8 million for autism research 2Rutgers Genetics receives $7.8 million for autism research 3
Mouse polyclonal antibody to BTAF1 - BTAF1 RNA polymerase II, B-TFIID transcription factor-associated, 170kDa (Mot1 homolog, S. cerevisiae)...
... PHD2000 syringe pump series combines Harvard Apparatuss best ... and a wide range of configuration options. A ... dimensions of syringes from all the major manufacturers. ... all the pertinent information from across the lab. ...
ACS Reagent Grade C 19 H 14 O 5 S Formula Weight: 354.38 PRODUCT SPECIFICATIONS Form: Rust/red crystalline powder Clarity of Solution: Passes test Visual Transition Interval: pH 6.8 - Yellow pH 8.2...
... NTI allows you to store and manage ... in a secure central relational database. Storing ... an invaluable resource for clone tracking and ... for immediate analysis. LabShare software integrates seamlessly ...
Biology Products: