For the past 18 years, I have lived and breathed the toughest challenges in advanced therapy CMC — with an unrelenting focus on mRNA-LNP platforms, adeno-associated virus (AAV), and lentiviral vectors (LVV).

I specialize in taking these modalities from early research all the way through Process Performance Qualification (PPQ) and commercial readiness — repeatedly, predictably, and under full regulatory scrutiny.

Services Offered

mRNA & LNP Platform Development

• End-to-end support from sequence design to commercial manufacturing, including non-hepatic targeting via ligand and antibody conjugation.

• Expertise in potency optimization, achieving up to 15x improvements for base editing and immunotherapy.

• CDMO selection, tech transfer, and IND/BLA authoring under QbD frameworks.

AAV & LVV Process Intensification

• Upstream/downstream optimization for serotypes 2–9, delivering 100x yield boosts through plasmid redesign and bioreactor scaling.

• Lysis-free harvest strategies and affinity-free purification for GMP compliance.

• PPQ execution, comparability protocols, and regulatory strategy for Phase 3 and beyond.

Analytical & Regulatory CMC Consulting

• Development of robust assays for capsid integrity, potency, and impurity profiling (e.g., residual DNA, host cell proteins).

• Preparation of CMC sections for FDA/EMA submissions, including pre-IND meetings and rolling BLAs.

• Risk-based validation for cleaning, equipment, and processes to ensure audit-ready operations.

Strategic Advisory & Tech Acquisitions

• Guidance on platform expansions, site development, and M&A evaluations in nucleic acids and gene therapy.

• Custom AI-driven modeling for process predictions and yield forecasting.

• Keynote consultations on emerging trends like extrahepatic delivery and hybrid modalities.

Reach out: 

aalok.shah@bioaiconsulting.com 

617.610.5840