R&D Design / Lead Molecule Development / Preclinical Development
R&D Design researches targets of a disease with high potential for treatment, designs candidate substances specific to those targets, and sets the target product profile of the substances. Preclinical Development and Lead Molecule Development then selects and optimizes a substance that displays the targeted efficacy, safety, and development potential though in vitro and animal model experiments. With comprehensive understanding of the pharmacokinetic and toxicological properties of the optimized substance, the plasmid used for the production cell line is created and the basis and rationale for clinical development of the substance is established.
- Novel Target Discovery / Product Profile Establishment
- New Biological Entity Design / Production
- Entity Selection
- Entity Optimization
- PK/PD Analysis
- Toxicity Analysis
Cell Line Development
A Cell Line is critical in determining a biological drug's quality, safety, and productivity. Cell Line Development bridges the gap from research to production, serves as a starting point of all production, and lays the foundations of production through transfection, cell cloning, cell selection, cell line stability and ultimately to securing a highly productive cell line for commercial production.
- Pool Selection of Transfected Cells
- Clonal Screening and Selection
- Cell Line Characterization
- Cell Line Stability
- Cell Banking
Upstream Process Development
Reaching a desired target product profile and productivity with only a superior cell line is very difficult. Each cell line is unique, hence, requires a compatible and optimized cell culture process is essential for success. Through extensive analysis and understanding of the characteristics of each cell line, Upstream Process Development designs, develops, selects, and optimizes the cell culture process with respect to various elements to maximize the potential of each cell line.
- Cell Culture Process Design
- Secondary Clonal / Media Screening and Selection
- Product Profile Optimization
- Cell Culture / Production Strategy Development
- Process Scale up / Tech Transfer
- Upstream Process Support
Downstream Process Development
The number on concern in developing a purification process is to ensure the safety of the drug. From raw materials to the manufacturing environment, there are many sources where a safety compromising impurity can originate from. Downstream Process Development assesses the risks of those impurities, designs, and develops a purification process capable of eliminating the impurities and optimizes the process to yield high-purity drugs to ensure consumer safety.
- Purification Process Design
- Chromatography Strategy Development
- Virus / Impurity Control Strategy Development
- Product Structural Analysis
- Process Scale up / Tech Transfer
- Downstream Process Support
An exhaustive analysis of the complex molecular properties, mechanism of action, and binding activity of biological drugs is absolute to understand a drug’s pharmacological, pharmacokinetic, and toxicological properties and in protecting patient safety. Analytics designs, develops, and qualifies accurate, precise, and robust analytical methods used for such drug quality analysis.
- Analytical Method Development / Qualification
- Comparability / Similarity Analysis
- Product Quality Analysis
- Physicochemical Analysis
- Biological Analysis
- Analytical Support