How Drug Developers Use a Feasibility Study to Protect Their Investment
Pharmaceutical manufacturers use feasibility studies to ensure the solution they would implement (equipment, system, process…) meet their expectations in compliance with highest standards. Consider it “a trial run”. This process is used to test, fine-tune, and ultimately solidify manufacturing steps, materials and equipment. Without a feasibility study, discrepancies are exposed and lead to wasted time and resources. Therefore, investing in the proper equipment upfront, thanks to feasibility data, contributes to time and money savings.
bioMérieux can offer pharmaceutical manufacturers peace of mind in their QC and IPC testing investment by proposing feasibility studies thanks to customized approach expertise, accuracy, and ease of workflow to facilitate compliance.
What is a Feasibility Study?
First, let’s begin with the basics. A feasibility study is designed to help decision makers determine whether a proposed project or investment is likely to be successful. It identifies both the known costs and the expected benefits. The study tries to determine whether the project is technically and financially feasible.
In the United States, it wasn’t until 2011 that the U.S. Food and Drug Administration (FDA) issued guidance for feasibility tests to be conducted. Up to then, this was not described and standardized.
Today, similar to the FDA, the European Medicines Agency (EMA) draws guidelines to address registry-based studies to support regulatory decision-making, data collection, data quality management and data analysis to active higher quality evidence.
Top Recommendations for Feasibility Studies
Whatever the project before investing, a feasibility study, helps a drug manufacturer determine technical and financial compatibility with their project. They need to prove relevance and efficiency of the potential investment to contribute to process success. Product feasibility helps to take a decision.
Other recommendations for a feasibility study are:
- Use a supplier's partner or the supplier to carry more weight in the analysis in term of process/equipment knowledge and expertise.
- Perform an early-stage feasibility study (during the pre-development stage), as this would be more advantageous
Although the development and manufacturing steps are sometimes similar, the final process used for each pharmaceutical product is entirely unique, especially for biological products. Hence the reason for customized feasibility studies.
Quickly Confirm Your Product Compatibility and Method
A feasibility study is probably the single most important consideration when it comes to changing your method of application. One will quickly confirm your product compatibility and method.
To save time, resources, and energy, it’s a vital aspect of ensuring compatibility that meets every calculated need of a manufacturer’s process.
Proving compatibility requires resources and expertise, so partnering with bioMérieux for customized studies helps you undertake the necessary feasibility studies, giving you the time to focus on your priorities.
bioMérieux provides high-quality products and applies these exact standards to our feasibility studies, thus ensuring the same meticulous attention to regulatory compliance and quality of results. These experimental studies are performed in our application laboratory using your samples and microbial strain(s).
Depending on the scope of your project, we will assemble a team of experienced scientists with the right expertise (e.g. expertise in Mycoplasma detection, Endotoxin detection, Sterility testing, etc).
We can also offer a non-demand study for any specific needs or requirements you may have. Our experts can design, perform and provide you with all the necessary documentation for your peace of mind. bioMérieux offers:
- Product compatibility assessment
- Service includes 1 product and up to 2 strains
- Additional products and/or strains can be quoted as an option
- Duration: 4 to 6 weeks
- Deliverable: customized presentation and/or study report
We can develop the feasibility study you need. In doing so, we’ll prove the compatibility of your matrices with a validated bioMérieux platform regarding your microbiological specification(s).
Proving compatibility requires resources and expertise. We are here to help you undertake the necessary feasibility studies, giving you the time to focus on your priorities.