Harmony Consulting
Case Studies
With over 25 years of experience in the biopharmaceutical industry from the bench to the boardroom, we have the expertise to solve your problem. We have included a few case studies from some of our recent projects.
Schedule a consultation with us to find out how we can assist you and help you accomplish your goals faster and more efficiently.
Cell Therapy Project
Entry into Phase 1 With New Technology
The Challenge:
A cell therapy company is looking to make the jump into first-in-human trials from R&D studies. They have no previous experience with filing and IND.
Why Harmony?
Harmony was chosen because of their track record of working with small companies in emerging technological areas such as cell therapy and gene therapy and their long record managing successful regulatory submissions.
The Solution:
Harmony staff rapidly came up to speed with the technology and conducted a gap assessment for the company to determine what was needed to achieve compliance for P1 standards for a new cell therapy product. A game plan for each area (non-clinical, clinical, CMC, regulatory) was created with consensus with company staff, and converted into a simple table of contents. Harmony collated input from company staff into an IND while providing strategic guidance. Questions and responses from FDA were handled efficiently during the review period. The result was a successful approval of the IND and a rapid start for the P1 trial.
Are you facing a similar challenge?
Small Molecule Oncology Project
New Operational Systems for GMP Compliance
The Challenge:
A company needed to create a GMP-compliant manufacturing system for its new small molecule product.
Why Harmony?
Harmony was chosen because of our depth and breadth of expertise in GMP operations. We were chosen because we offer a cost-effective, development-phase appropriate “Goldilocks” approach – do not do too much or too little – do the right amount of GMP compliance for the phase of development.
The Solution:
Harmony wrote an initial suite of 50 SOPs and batch records, along with an overarching Quality Manual. The company was audited and found to be compliant with GMP for clinical trial manufacturing.
Are you facing a similar challenge?
Biotech Product - Aseptic Filling Project
Validation of A New Commerical Plant
The Challenge:
A company needed to perform validation of a new pilot-plant / early commercial manufacturing facility for an aseptically filled biotech product.
Why Harmony?
Harmony was chosen because of its documentation creation and technical writing skills, and the ability to rapidly create documents that are “fit-for-purpose” and useful for end-users while still being GMP compliant.
The Solution:
Harmony developed Validation Master Plans (VMPs) for equipment, computers, utilities, cleaning/environmental monitoring , and processes in accordance with FDA guidelines. In addition, Harmony wrote the critical process SOPs and validation protocols and coordinated with the architect and engineering firms. The facility was operational on time and on budget.
Are you facing a similar challenge?
Monoclonal Antibody Project
Technology Transfer
The Challenge:
A company needed to transfer manufacturing of a radiolabeled monoclonal antibody product to a different facility.
Why Harmony?
Harmony was chosen because of our knowledge and extensive experience with antibodies and radionuclides.
The Solution:
Harmony sourced and audited prospective vendors. Within 6 months, the transfer was completed and submitted to FDA, saving the company $3 Million per year in manufacturing costs.
Are you facing a similar challenge?
