Personal Information
Entreprise/Lieu de travail
New Delhi Area, India, Uttar Pradesh India
Secteur d’activité
Government / Military
À propos
Working with National Institute of Biologicals, under the aegis of Ministry of Health & Family Welfare, Govt. of India
Ability to multitask across platforms (QC, Informatics & Accreditation services). About 20 years experience in QC/QA of Biologics (Biotherapeutics - mAbs, enzymes, Immunodiagnostics - Infectious disease marker testing) in a well regulated, fast paced environment for Biologics. Keen observer and follower in the global developmental studies & regulations in biologics. Application of BIOSTATISTICS & INFORMATICS to development of bio-therapeutics, QbD-GMPs.
Expertise includes development of in-house method validation protocols, SOPs, assistance in managing labs compliant wit...
Mots-clés
usp
biosimilars
cell culture
biologicals
biotherapeutics
biologics
chemical medicines
medicines
vaccines
who guidelines
evaluation
sbps
therapeutic monoclonal antibodies
similar bio therapeutic products
protein characterization biologics
therapeutic monoclonal antibodies approved
monoclonal antibody quality safety biologics
aggregation monoclonal antibody
cancer therapy
targeted therapy
target product profile
in-vitro diagnostics
ivds
biomarkers
molecular diagnostics
protein therapeutics
biosimilar industry
evaluation of biosimilars
biosimilar
biosimilar similarity
biosimilar development
who reference standards
who reference reagents
therapeutic monoclonal anti
clinical trials biosimilars
potency testing of cell based immunotherapy medici
monoclonal antibodies
media cell culture cho
media cell culture
raw materials
media improvement
cell culture raw material management
cell line
chemical medicines & excipients
validation
novel formulations
chemical medicines
novel formulations
united states pharmacopoeia
united states pharmacopoeia
status
global
current
quality control testing
innovators
reference standards
bio-banking
basic needs
bioassay - design of experiment
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