Development Processes
Biotech Development Process
Discovery
Identify potential biological targets (e.g., proteins, genes) and compounds that can interact with these targets. This often involves high-throughput screening and bioinformatics.
- Clinical
- Bioanalytics & Single Cell
- In silico screening, medicinal chemistry
- Bioinformatics
- Additional testing:
Mammalian cell and biological therapies development
Microbial fermentation
Testing (concurrent with steps 1-3)
Bioanalytical, immunology, cell-based assays, immuno assays
Process Development (concurrent with steps 1-4)
Small Volume Manufacturing
Preclinical Research
Scale up
Clinical Trials (click logo for link)
Quality/Regulatory (click logo for link)
Pharma Development Process
Target discovery and validation
RNAi knockdown screening and CRISPR knockout screening: Target Discovery Core
Knock in and overexpression reporter cell line generation
High Throughput Screening
Computer-aided and structure-guided drug design
Lead optimization by medicinal chemistry
ADME/DMPK studies
Formulation and Chemistry Manufacturing Control
Small volume manufacturing
Preclinical testing and IND enabling studies
Regulatory Approval
Clinical Testing (click on logo for link)
Phase 1:
Phase 2:
Phase 3:
Medtech Development Process
Development of initial concept design
Initial prototype
Prototype bench testing
Cadaver surgical method testing
Redesign
Small volume manufacturing
Stress testing
Biocompatibility testing
Wear testing
Usability testing (click on logo for link)
Clinical Testing (click on logo for link)
Regulatory/Quality (click on logo for link)