CMC Strategy & Execution
Development planning, regulatory-aligned CMC strategy, phase-appropriate program design.
Integrating CMC strategy, manufacturing insight, and quality systems expertise to accelerate groundbreaking therapies to patients.
About
End-to-end support across all phases of biopharmaceutical development.
Dianthus Biopharma Consulting, LLC, founded in March 2021, provides end-to-end support across all phases of biopharmaceutical development, with deep expertise in process and analytical development, tech transfer, manufacturing, quality control, and CMC Regulatory 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 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
Manufacturing & Technical Operations
Process development, scale-up, technology transfer, GMP readiness, and operational troubleshooting.
Quality Control & Analytical Strategy
Analytical method development, qualification/validation planning, QC oversight, and lifecycle management.
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.
Diane I. Blumenthal, MSE
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.
- President of Dianthus Biopharma Consulting, LLC.
- Before founding Dianthus Biopharma Consulting, she served as Senior Vice President and Head of Technical Operations at Spark Therapeutics.
- Links to her full CV and LinkedIn profile are provided for earlier leadership roles and career milestones.
Leadership Highlights
- Senior Vice President and Head of Technical Operations at Spark Therapeutics, where her leadership contributed to the approval of Luxturna® and the first licensed viral vector manufacturing facility in the United States.
- Vice President of Manufacturing Sciences and Technology at Eli Lilly and Company following its acquisition of ImClone Systems.
- Played a key leadership role in approvals for 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
Connect with Dianthus Biopharma Consulting.
Send a brief note about your program, timeline, and support needs. Each inquiry is reviewed directly and followed up by email.