SMAT Consultants (South Mountain Advanced Therapies Consultants, LLC) is a specialized AAV gene therapy CMC practice providing strategy, execution, and senior leadership to drug developers, manufacturers and CDMOs, as well as investors. SMAT Consultants supports clients in the U.S. and Europe, with expanding activity in Japan.
Clients work directly with founder Franz Gerner, PhD, who brings more than 30 years of AAV gene therapy CMC experience, spanning hands-on process and analytical development, CMC leadership, as well as service as Chief Technology Officer at Excision BioTherapeutics, an AAV-CRISPR company. Earlier roles include Vice President of Technical Operations at Sio Gene Therapies and Senior Director at REGENXBIO. He holds three granted patents in AAV manufacturing and purification and serves on the ASGCT CMC Steering Committee, as well as the Cell & Gene Therapy Insights Editorial Advisory Board.
Drug developers. SMAT Consultants combines CMC strategy with hands-on execution in one senior resource, supporting programs from early development through commercial readiness. Services span vector design and manufacturability, plasmid and cell line development, upstream and downstream processing, drug product and formulation, analytical development and potency assay strategy, CDMO selection and management, stability and comparability, technology transfer, as well as CMC support for IND and CTA submissions.
Manufacturers and CDMOs. Support includes facility and equipment design from an operational manufacturing perspective, including manufacturing suite layout, cleanroom classification, equipment selection, as well as utility requirements. Analytical support includes method selection, assessment of platform and product-specific testing needs, as well as selection of equipment required to support those methods. SMAT Consultants also supports process and analytical development, troubleshooting, technology transfer, as well as transfer of materials. Where useful, SMAT Consultants can work directly with the drug developers a manufacturer serves to resolve technical issues, establish realistic expectations, and support efficient program transfer.
Investors and strategic partners. Services include technical due diligence and COGS analysis for gene therapy assets, covering manufacturing strategy, scalability, analytical readiness, technical risk, as well as cost per dose. Post-investment support can include CMC strategy review, improvement planning, review of technical and investor materials, as well as service as a board director, board observer, or Scientific Advisory Board member.
Flexible engagement. Engagements are sized to the client’s needs rather than to a predetermined consulting model. Support can range from a few hours for a focused question, data review, or technical challenge up to recurring support several days per week. Options include hourly or retainer-based advisory, focused projects, fractional CMC leadership, as well as interim CTO engagements. Support can expand or contract as program needs change, giving clients direct access to senior AAV CMC expertise without requiring a full-time hire or a large consulting team.