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
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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