ISOGEN - CDMO

Contract Filling

• Potent and non-potent therapeutics including vaccines, mAbs, and other synthetic or biologically derived API’s.
• Vials or Syringe fills
• Liquids or Lyophilized
• Science Center Intermediate scale GMP filling for batch sizes up to 6,000 per shift for Sterile Clinical Supplies and orphan drugs. Transitional scale filling for batch sizes up to 100,000 coming in 2012.

ISOGEN - Pharmaceutical Sciences

Analytical Laboratory Support:

• Full service pharmaceutical analytical test and methodology development. Offered as part of a filling contract or as a standalone fee for service contract.
• API, Drug substance testing
• Pharm QC in process testing
• Pharmacokinetics
• Stability studies
• Physical chemical properties testing
• Limits testing
• Dosage form development
• Pre-formulation and excipient compatibility studies
• Pharmaceutical methods development and validation
• AND MUCH MORE

Pharmaceutical Tech Development:

• Pharmaceutical development sciences available as a standalone service offering or as part of an integrated project of preclinical or early stage clinical filling service, including:
• Materials compatibility
• Mixing and holding studies
• Filtration and single use fluid path development and validation
• Freeze drying development and validation
• Filling development and container closure development and validation
• Terminal sterilization development and validation
• Material handling and shipping development
• AND MUCH MORE

Pharmaceutical Tech Transfer:

• Application of above listed pharmaceutical development sciences to demonstrate process equivalency when a therapeutic is transferred in to ISOGEN for contract filling. Fully documented and validated.

ISOGEN - Advanced Barrier Process Consultancy

GMP Project Management for Aseptic Processing Equipment and Isolators

• Aseptic process equipment from concept through design, documentation, pre-val testing, validation, and licensing support.
• Incorporate GAMP4 type methodology to engineer quality systems into the final solution.
• Isolator and Barrier Systems (including RABs)
• Filling Lines: Washers, fillers, tunnels, cappers, lyophilizers, loading systems, vial ID, inspection, packaging
• Support Equipment: Stopper processors, CIP skids, autoclaves, dry heat ovens
• Support Services: Ready to sterilize and ready to use components (stoppers, overseals, and vials)
• Additional capabilities in bioprocess development, including cell culture and purification.

GMP Project Management - Objectives

• Establish early the project scope
• Maintain the project schedule and budget (early scope definition minimizes cost escalation)
• Establish the vendors as partners
• Allow people changes without affecting project integrity
• Minimize impact on internal resources through effective time management
• Build in 21CFR Part11 & Regulatory Compliance

GMP Project Management - Documentation Structure

• Process Description and URS: Sets foundation
• FS, HDS, SDS (DDS):
  • Design specifications by vendors w/ draft traceability matrices to URS.
• GMP Risk Assessment:
  • Provides key rationale for design and validation activities.
• Pre-Validation Testing:
  • Prioritize and leverage vendor internal testing, FATs, and
  • SATs where appropriate.
• Validation Testing: (IQ/OQ/PQ)
  • Execute tests on fully debugged and operational systems with great speed and efficiency.
  • Traceability Matrix: Tie testing to specifications.