Staying ahead in biotech requires fast access to clear, reliable, and actionable information
The Harmony Biotech Resource Hub brings together valuable content - blogs, case studies, and videos - so leaders can quickly find answers, explore best practices, and learn proven approaches used across the life sciences industry.
Whether you're planning your next development milestone, evaluating partnerships, or preparing to scale, these resources provide the strategic context and operational guidance needed to make smarter decisions.
Biotech insights & expert analysis
Our blog delivers concise, evidence-based insights on the topics shaping today's biotech environment. Each article breaks down complex challenges in areas like R&D strategy, regulatory navigation, operational scale-up, and commercialization planning. The goal: provide biotech leaders with practical, actionable guidance they can apply immediately.
Trends in BARDA Funding and What They Mean for Emerging Biotech Companies
The Biomedical Advanced Research and Development Authority (BARDA) plays a vital role in supporting innovative biotech companies that develop products to protect public health. BARDA funding has shaped the life sciences landscape by accelerating vaccines, therapeutics, diagnostics, and medical countermeasures. For emerging biotech firms, understanding current trends in BARDA funding is critical to securing grants…
Is Your Biotech Company Eligible for BARDA Funding? A Step-by-Step Assessment
Biotech companies aiming to develop medical countermeasures often wonder if they qualify for funding from the Biomedical Advanced Research and Development Authority (BARDA). This article will provide a detailed, step-by-step guide to help you assess your company’s eligibility for BARDA funding. Understanding this can open doors to critical financial support for advancing vaccines, drugs, diagnostics,…
Understanding BARDA Funding: Grants, Contracts, and Partnerships Explained
Public health emergencies and biothreats require fast, focused innovation. The Biomedical Advanced Research and Development Authority (BARDA) plays a critical role in this space. If you work in biotech, pharmaceuticals, or public health, knowing how BARDA funding works can open doors to funding that accelerates your development. This article provides a clear, detailed guide to…
Biotech case studies: Real strategies, real results
Explore how biotech organizations have worked with Harmony Biotech to overcome operational challenges, accelerate timelines, and prepare for key inflection points. These case studies highlight proven frameworks, collaboration models, and measurable outcomes that support faster development and more effective decision-making.
Harmony Biotech Consulting
Featured case study: Drug development project
A commercial-stage biopharma company needed to scale its lyophilization process to meet EMA/FDA Requirements without major capital investment. Harmony redesigned upstream equipment and single-use technologies, developed and defended a robust validation strategy, and enabled a 10x scale-up using existing infrastructure. The solution avoided $10M in costs, prevented an 18-month delay, reduced regulatory risk, and ensured supply chain continuity.
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.
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.
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.
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.
Biotech FAQ videos: Fast answers to common leadership questions
Our FAQ videos offer quick, high-value explanations to the questions biotech leaders ask most. Each short video provides clear, practical guidance on topics such as resource planning, partnership strategy, operational excellence, and growth readiness. Ideal for teams needing reliable answers - fast.
