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Molecular Biology, Cell Biology, Histology, Pathology, Microbiology, Protein Chemistry, Biochemistry, Microscopy, Nanotechnology, Glycobiology, Pharmaceutical Formulations
Product Development, Process Development, Scope, Schedule, Budget, Documentation Control, Design Control, Market Analysis, Trends Analysis, Competitive Landscape, Tech Transfer, Regulatory Compliance
Biomarkers are disease indicators. They are found in cells, tissues and body fluids and can be used as disease predictors. They can be proteins, nucleic acids, or other biomolecules. Their biochemical diversity will determine the methodology used for testing and analysis.
Biopharmaceutical and diagnostic applications are based on well-defined assays. It is important to understand what molecule is analyzed and what property is measured. Assays can vary from one analyte in one sample to many analytes in multiple samples.
Biotech laboratories, from early R&D to manufacturing, can have very different operational guidelines. They need to consider technology and equipment characteristics, personnel training, regulatory rules, and business operations.
1.
This is the first part of the process and as any beginning, it needs to be treated with spatial care. Good planning requires good information. Among others, think of customer requirements, business needs, resources, regulations, competitive landscape, trends, risks, and benefits. This information is the basis of the effective development plan.
2.
A feasibility study often stands at the beginning of the development process. It is important to understand if the intended product or technology is capable of delivering intended benefits. In later development, the focus shifts to making sure that it can be made in a reliable, reproducible, and cost-effective way that complies with regulatory requirements.
3.
At this stage, the goal is to advance the prototype or technology to a commercial product. It involves different business departments, such as manufacturing, quality control, or marketing. This complexity is addressed by cross-functional teams and effective project management. The goal is to coordinate different departments and have timely product launch.
4.
Post-launch activities are just as important in the life cycle of a product. Quality control is continuously monitored. Collected data is used to improve processes. Good customer supports is essential. Customer feedback is used to ensure that the products maintain good fit with customer requirements. It is also used for the planning of the next generation of products.