Manufacturing & Technical Operations
Process development, scale-up, technology transfer, GMP readiness, and operational troubleshooting.
Dianthus Biopharma Consulting, LLC
Integrating CMC strategy, manufacturing insight, and quality systems expertise to accelerate groundbreaking therapies to patients.
Our mission is to empower biopharma organizations across the development spectrum with clear, science-driven strategic guidance that accelerates development, strengthens decision-making, and advances therapies that improve patient lives.
Diane I. Blumenthal helps biopharma organizations across the development spectrum with practical support in process development, analytical development, technology transfer, manufacturing, quality control, and Regulatory CMC.
- President-led advisory support with direct senior-level access
- Independent consulting backed by a trusted network of proven experts
- Focused on clear decisions, compliant execution, and patient impact
Mission
Clear, science-driven strategic guidance across the development spectrum.
Empowering biopharma organizations to accelerate development, strengthen decision-making, and advance therapies that improve patient lives.
March 2021
Founded
Nearly 40
Years of experience
6
Well-known products
About
End-to-end support across all phases of biopharmaceutical development.
Founded in March 2021, Dianthus Biopharma Consulting, LLC provides end-to-end support across all phases of biopharmaceutical development, with deep expertise in process and analytical development, technology transfer, manufacturing, quality control, and Regulatory CMC support.
The company partners with organizations to advance programs from early development through commercialization and lifecycle management. With a focus on scientific rigor and operational excellence, Dianthus Biopharma Consulting helps clients build robust, compliant, and scalable manufacturing processes to deliver high-quality medicines to patients.
Dianthus Biopharma Consulting is a sole-proprietor consultancy, strengthened by a trusted network of proven industry experts who can be engaged to meet program demands.
Capabilities
Core Areas of Expertise
Quality Control & Analytical Strategy
Analytical method development, qualification/validation planning, quality control oversight, and lifecycle management.
CMC Strategy & Execution
Development planning, regulatory-aligned CMC strategy, and phase-appropriate program design.
Regulatory CMC Capabilities
Focused expertise in Regulatory CMC, including preparation and refinement of CMC content for INDs, IMPDs, BLAs, and MAAs. We develop phase-appropriate strategies, align data packages with global expectations, and guide teams through regulatory interactions to ensure clear, cohesive, and defensible submissions.
Together, these capabilities enable clients to build efficient, compliant, and scalable processes from concept through clinical development and into commercialization.
Bio Synopsis
Diane I. Blumenthal is a CMC executive with nearly 40 years of experience.
President
Diane I. Blumenthal, MSE
President of Dianthus Biopharma Consulting, LLC, and a CMC executive with nearly 40 years of experience leading teams across process and product development, clinical and commercial manufacturing, quality control, scientific facilities operations, program management, and CMC regulatory.
Bio Synopsis
Diane is a CMC executive with nearly 40 years of experience leading teams across process and product development, clinical and commercial manufacturing, quality control, scientific facilities operations, program management, and CMC regulatory.
Before founding Dianthus Biopharma Consulting, she served as Senior Vice President and Head of Technical Operations at Spark Therapeutics. At Spark, she set the strategic direction and provided operational leadership that enabled regulatory approval of Luxturna®, the first gene therapy approved for the treatment of a genetic disorder, including the first viral vector manufacturing facility licensed in the United States.
Prior to Spark, Diane was Vice President of Manufacturing Sciences and Technology at Eli Lilly and Company, following its acquisition of ImClone Systems. In this position, she played a key leadership role in the approvals of Erbitux® and Cyramza®, two monoclonal antibody therapies to treat cancer.
For a full view of Diane's earlier leadership roles and career milestones, links to her CV and LinkedIn profile have been provided.
Contact
Start a conversation with Dianthus Biopharma Consulting.
Send a short note about your program, timeline, and the support you need. Diane reviews each request directly and will reply to you shortly.