Test
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
https://uthscsa.edu/research/clinical-studies
https://www.pinnacleresearch.com/sponsors-cros/
https://lumabridge.com/capabilities/
https://flourishresearch.com/locations/san-antonio/about-us/
https://www.universityhealth.com/services/clinical-trials-research
https://bamc.tricare.mil/About-Us/Research-and-Education/Department-of-Clinical-Investigations
https://usaisr.health.mil/index.cfm/burn_center/clinical_research
https://iims.uthscsa.edu/clinical/clinical-research-services/bru/
Regulatory Approval
Pharma Development Process
Target discovery and validation
Using RNAi knockdown screening and CRISPR knockout screening (UT San Antonio)
Knock in and overexpression reporter cell line generation
For high throughput screening (HTS) (UT San Antonio)
High Throughput Screening
assay development and optimization and HTS (UT San Antonio)
Computer-aided drug discovery
(including druggable site identification, hit discovery by virtual screening, de novo drug design, and artificial intelligence-based analog searching for hit-to-lead optimization) (UT San Antonio and SwRI)
Lead optimization by medicinal chemistry and structure-guided drug design
ADME/DMPK studies
Formulation and CMC
Small volume manufacturing
Preclinical testing and IND enabling studies
Regulatory Approval
Clinical Testing
Phase 1:
https://uthscsa.edu/research/clinical-studies
https://www.pinnacleresearch.com/sponsors-cros/
https://lumabridge.com/capabilities/
https://flourishresearch.com/locations/san-antonio/about-us/
https://www.universityhealth.com/services/clinical-trials-research
https://bamc.tricare.mil/About-Us/Research-and-Education/Department-of-Clinical-Investigations
https://usaisr.health.mil/index.cfm/burn_center/clinical_research
https://iims.uthscsa.edu/clinical/clinical-research-services/bru/
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
https://uthscsa.edu/research/clinical-studies
https://www.universityhealth.com/services/clinical-trials-research
https://bamc.tricare.mil/About-Us/Research-and-Education/Department-of-Clinical-Investigations
https://usaisr.health.mil/index.cfm/burn_center/clinical_research
https://iims.uthscsa.edu/clinical/clinical-research-services/bru/
Clinical Testing
https://uthscsa.edu/research/clinical-studies
https://www.universityhealth.com/services/clinical-trials-research
https://bamc.tricare.mil/About-Us/Research-and-Education/Department-of-Clinical-Investigations
https://usaisr.health.mil/index.cfm/burn_center/clinical_research
https://iims.uthscsa.edu/clinical/clinical-research-services/bru/