Our Services
Proprietary Cell Line Development Services
The CELLTHEON SMART Platform has been used to date in 60+ biologics from oncology to neurobiology and RA programs, including five (5) biosimilars.
- 12-14 weeks to RCB
- High titers: 6-8g/L
- >120 gen. stability
- Scalable, commercial fed-batch platform
- Built in QbD
- Low metabolic waste
- No gene amplification
- No pool enrichment
- No automated colony selection equipment
Bio-Development Services
- 30,000 Sq. Ft. cGLP Mid-Size Bioprocessing Facility
- Perform Process Development, Process Scale-Up & Process Characterization Operations up to 200L
- Perform Analytical Method Development
Future Partnering Services
- Large-Scale Bioprocessing Operations including Fill/Finish Operations & Packaging/Labeling
- Pre-Clinical (Animal) Studies
- Toxicology Studies
- Human Clinical Trial Management including Patient Recruitment
- Drafting & Submission of Regulatory Applications
- Regulated Marketing/Advertising Services
- Prescription Formulary Placement with Medical Payers (Health Insurers)
- Pharmacovigilance
- Amendments & Annual Filings to Support Your Post-Commercial Regulatory Commitments including PDUFA Fees
Our Facility
COMING SOON in Q4-2021: Large-Scale cGMP Bioprocessing Facility (BSL-2) in/near Philadelphia, PA
Features
- 60,000 Sq. Ft. iCON Facility
(BSL-2) – built by IPS-Integrated Project Services, LLC in partnership with G-CON Manufacturing
- PALL Biotech Platform Single-Use Equipment
- 30,000 Sq. Ft.: Suspension Cell Bioprocessing
- 30,00 Sq. Ft.: Adherent Cell Bioprocessing
- Cloud Software/E-Documentation
- Proprietary Mobile/Web Applications
- Strategic Partnership with HelaPlex: Commercial Co-Working for Life Science Start-Ups & Virtual Biotech Companies