Laboratory and Testing
Outsourcing Facility
Full-service FDA Registered Outsourcing Facility/Compound Pharmacy
- Four Aspects of Compounding Capabilities
- USP 800 Sterile Hazardous
- USP 800 Non-Sterile Hazardous
- USP 797 Sterile Non-Hazardous
- USP 795 Nonsterile Non-HD
- 3 Production Suites
- Registered Pharmacist on Staff
- Key Activities
- Funding and Design – Completed
- Equipment (BSC/Hoods) Procurement – Completed
- Procurement of Materials/Space Buildout – Target May
- Clean Rooms/Equipment Qualification – Target May
- Establishment Application w/FDA & State Board Pharmacy – Pending
![Technical-Solutions](https://victogenpharma.com/wp-content/uploads/2021/08/Technical-Solutions.jpg)
Laboratory and Testing
Development Laboratory
- Formulation and Lyophilization Development
- Method Development
- Pilot Scale Manufacturing
![Development Laboratory](https://victogenpharma.com/wp-content/uploads/2021/08/Development-Laboratory.jpg)
Laboratory and Testing
Stability Testing
- Validated Stability Chambers
- Full UPS and Generator Backup
- 25C / 60% RH (long term)
- 30C / 65% RH (intermediate)
- 40C / 75% RH (accelerated)
- 2C to 8C (refrigerated)
- -20C (frozen)
- -80C (frozen)
- -140C (frozen)
- Photostability Chamber
![Stability Testing](https://victogenpharma.com/wp-content/uploads/2021/08/Stability-Testing.jpg)
Laboratory and Testing
Testing Laboratory
- Full scale GLP Testing Capabilities.
- Assay development across a variety of target types and therapeutic areas using a broad range of formats for low to high-throughput applications.
- Custom Cell and Molecular Biology Research Services.
![Laboratory Testing](https://victogenpharma.com/wp-content/uploads/2021/08/Laboratory-Testing.jpg)
Laboratory and Testing
Cancer Cell Development
- PhD scientist who is an expert in Cancer cell development
- Expertise in cell-based assays to support early-stage drug development
- Assay development across a variety of target types and therapeutic areas using a broad range of formats for low to high-throughput applications
- Preclinical Validation of Therapeutic Leads
- In Vitco efficacy testing
- Example Readouts
- Cytotoxicity & Cell Proliferation Assays
- Real-Time Apoptosis/Necrosis Detection
- Migration/Invasion Assays
- Transformation Assays
- Deconvolution of mode of action
- Cell Signaling Analysis
- Molecular and Genetic Analysis
- Biomarker Validation
- Custom Cell and Molecular Biology Research Services
- Full library/cell bank of human and mouse cells
![Cancer Cell Development](https://victogenpharma.com/wp-content/uploads/2021/08/Cancer-Cell-Development.jpg)