About Natalia Zisman
Natalia Zisman, founder of Minami Consulting, is an accomplished biopharma professional with over 20 years of specialized experience in drug development. She is particularly focused on the early-stage formulation and process development of Lipid Nanoparticle (LNP) Drug Products. Natalia’s expertise spans essential aspects of Chemistry, Manufacturing, and Controls (CMC), guiding projects from preclinical stages to Phase 2 clinical trials. Known for her hands-on approach, she provides strategic insights and technical leadership in the formulation development, technology transfer, and scalable manufacturing of LNPs and other lipid-based delivery systems. Her deep understanding of encapsulated modalities (including small molecules, peptides, and nucleic acids) makes her an invaluable partner in advancing innovative therapeutics.
Services Offered
Minami Consulting offers a suite of services tailored to early-stage drug development, with a focus on Lipid Nanoparticles (LNPs) and other lipid-based delivery systems:
- Product Development Consulting for Lipid-Based Delivery Systems: Specialized consulting for early-stage formulation and process development of various encapsulated modalities, including LNPs, liposomes, micelles, and polymer nanoparticles, to meet diverse delivery and therapeutic needs.
- LNP Manufacturing: Expert support in scaling up LNP formulations, from R&D to clinical manufacturing. This includes product characterization, equipment setup, production troubleshooting, and technology transfer to Contract Development and Manufacturing Organizations (CDMOs).
- CMC Strategy and Regulatory Documentation: Guidance in the preparation of essential GMP documentation such as SOPs, Batch Records, Deviation Reports, and Process Risk Assessments, ensuring compliance and seamless production workflows.
- Strategic Project Planning and Budgeting: Assistance in project planning, budgeting, and forecasting to streamline drug product development and optimize resource allocation.
Why Minami Consulting?
Minami Consulting merges scientific precision with practical expertise, supporting clients from research through to GMP manufacturing. With experience spanning both technical and client-facing roles, Natalia brings a well-rounded approach to biopharma development, balancing innovation with a focus on regulatory compliance and market preparedness.
Contact Natalia
To discuss how Minami Consulting can support your project, connect with Natalia on LinkedIn: