Frequently Asked Questions
1. What are the core functions of biopharmaceuticals?
The main concern of biopharmaceuticals is with the research, development, and commercialization of specific functioning formulations. That means we do lots of research work in determining and understanding the pathophysiology of a disease. Then, we set out to develop a biological treatment for it. After the period of testing and we have taken all the right steps, we make the drug available for use.
2. What capability does Synageva have to enable these functions?
Synageva has a team of dedicated researchers and healthcare professionals. Our team is committed to the avid discovery and following due process to ensure profound success. Also, we have well-equipped laboratories that are available for every procedure that we need to carry out. They’re all necessary and together contribute to the resources for our success.
3. Are the medicines safe, and do they have side effects?
As a biopharmaceutical company, we must ensure that any medicine we produce is efficacious and safe for use. It’s then we can carry out other tests that can determine the other properties. However, like pharmaceuticals, there are particular side effects for specific formulations. That’s where the risk to benefit ratio comes into play. We make sure the benefits outweigh the risk.
4. How does the company test the drugs manufactured?
The drug products and formulations Synageva manufactures undergo a lot of preliminary tests. The first set of tests involve various assays, including in-vivo and in-vitro assays. We test things like bioavailability, the onset of drug action, peak plasma time, half-life, shelf life, efficacy, and lethality. These tests are significant in determining if the drug can move to clinical trials.
5. Does Synageva conduct clinical trials?
Presently, our company doesn’t single-handedly conduct clinical trials. That’s because we’re generally more focused on the discovery and development stages of the drug production. These are the most crucial stages, and without them, there’ll be no drugs to test. Therefore, we focus our time and resources to ensure that we develop these drug molecules that serve as treatments.
6. Are these products regulated?
The CBER-Center for Biologics Evaluation and Research, a subsidiary of the Food and Drug Association (FDA), is responsible for biologics regulation. Firstly, besides establishing efficacy, the production process must be in line with Good Manufacturing Practices. Then, before they approve the product, it passes through years of clinical trials.
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