For analytical development, method/assay validation and qualification, quality control for release testing to ensure compliance with IND-enabling and BLA/NDA filings, it is led by Dr. Saikat Chakraborty, who previously had experiences in leading analytical development teams and Quality Control from Novartis, Genezen (CDMO), and Elanco.
Saikat Chakraborty, Ph.D.
Biography
Life Science and CMC Analytical Development Consultant with 10+ years of experience advising and leading analytical strategy across monoclonal antibodies and advanced therapies, including AAV9, lentiviral vectors, and retroviral vectors. Proven expertise in assay development, qualification/validation, analytical control strategy, tech transfer, and reference standard lifecycle management within GLP/GMPregulated environments. Strong track record supporting biotech startups, CDMOs, and sponsors through clinical development, CRO/CDMO oversight, and regulatory-aligned documentation. Adept at building teams, establishing laboratories, and delivering fit-for-purpose analytical solutions from early development through commercialization.
CONSULTING & TECHNICAL EXPERTISE
• CMC Analytical Strategy & Analytical Control Strategy (ICH Q2(R2), Q6B)
• Monoclonal Antibody & Protein Characterization
• Gene Therapy Analytics (AAV, LVV, RVV)
• Assay Development, Qualification, Validation & Lifecycle Management
• SEC-HPLC, CE-SDS (R/NR), cIEF Method Development
• ddPCR/qPCR, VCN Titer, Potency & Binding ELISA, Cell-Based Assays
• Corporate Reference Standard Generation & Lifecycle Management
• Tech Transfer to QC, CRO/CDMO Oversight
• Stability Study Design & Data Interpretation
• Startup Lab Setup, Talent Mentoring & Team Leadership
• Client-Facing Scientific Leadership & Regulatory Support