A5005811932- Biosimilars and Bioanalytical Methods
- CAR-T cell therapy research
- Biosensors and Analytical Detection
- Viral Infectious Diseases and Gene Expression in Insects
- Neurological diseases and metabolism
- SARS-CoV-2 detection and testing
- Higher Education Learning Practices
- Education Systems and Policy
- Molecular Biology Techniques and Applications
- Clinical Laboratory Practices and Quality Control
- Parkinson's Disease Mechanisms and Treatments
- Biomedical and Engineering Education
- Neonatal and fetal brain pathology
- Advanced biosensing and bioanalysis techniques
- Neuroscience of respiration and sleep
- Anesthesia and Neurotoxicity Research
- Amyotrophic Lateral Sclerosis Research
- Cardiovascular Health and Risk Factors
WuXi AppTec (United States)
2022
WuXi AppTec (China)
2019-2022
Gene therapy, cell therapy and vaccine research have led to an increased use of qPCR/ddPCR in bioanalytical laboratories. CROs are progressively undertaking the development validation qPCR ddPCR assays. Currently, however, there is limited regulatory guidance for a complete lack any guidelines newer support regulated bioanalysis. Hence, Global CRO Council Bioanalysis (GCC) has issued this White Paper provide; 1) consensus on different parameters required assays; 2) harmonized approach their...
The 13th GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5th, 2019. This meeting organized to discuss the contents of 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published February and consolidate feedback members. In attendance were 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies/sites. event represented a unique opportunity experts share their opinions concerns regarding build unified comments...
Gene therapy, cell therapy and vaccine research have led to an increased need perform cellular immunity testing in a regulated environment ensure the safety efficacy of these treatments. The most common method for measurement has been Enzyme-Linked Immunospot assays. However, there is lack regulatory guidance available discussing recommendations developing validating types Hence, Global CRO Council issued this white paper provide consensus on different validation parameters required support...
Abstract In the absence of regulatory guidelines for bioanalysis new drug modalities, many which contain multiple functional domains, bioanalytical strategies have been carefully designed to characterize intact and each domain in terms quantity, functionality, biotransformation, immunogenicity. The present review focuses on challenges considerations RNA-based drugs, bispecific antibodies multi-domain protein therapeutics, prodrugs, gene cell therapies, fusion proteins. Methods ranging from...
Objective To establish the 2-day-old SD rats model of periventricular leukomalacia (PVL) model. Methods A total number 84 2-day postnatal were randomly divided into 2 groups: The control group and PVL group. Rats in subjected to ligation right carotid artery, then they kept a box with 6% oxygen 94% nitrogen for 4 h animal model. Morphological observation, assessment neural behavior appraisal growth development have been made. Results The pathological changes was not obvious,...
Objective To develop a core information index system of disability for the elderly, which is suitable elderly in China and has educational guiding significance universal application value. Methods The framework was established through an extensive literature review expert discussions, constructed by Delphi consultation method. Results A total 74 experts (84 person-times)from various fields participated consultations.The positive coefficients five rounds consultations were...