High Potent & Oncology Development

Our Group with years of experience in pharmaceutical field, and handling of Highly Potent Intermediates and Active Pharmaceutical Ingredients (APIs) utilizes sophisticated technologies and the combined capabilities of multiple global facilities to produce Highly Potent pharmaceutical Drug Products and their APIs in collaboration with our manufacturing partners under Seatrack International Group in India.

Inthera PharmaMed is additionally experienced in the small-volume production of Highly Potent Peptide APIs (solid and liquid-phase) for commercial use, with containment safety systems and procedures suitable for the production of compounds with exposure limits as low as category 4, (<10 – 1 μg/m3) to <50 ng/m3.

Highly Potent & Oncology API Manufacturing

  • Manufacturing vessels with high flexibility in size (1-16,000 L), compatibility (Hastelloy, glass-lined, steel) and temperature (-110°C to +120°C)
  • QbD approach to development
  • Multiple filtration options (centrifuges, filter dryers, filter presses) and material compatibility (Hastelloy, stainless steel)
  • Multiple drying options (agitated & static dryers) and powder handling (isolator technology)
  • Complete focus on providing differentiated value to customers through our unique combination of technology and talent
  • Reliable supply to all regulated markets

Platform Capabilities

300,000 L of total manufacturing capacity containment principles:

  • Engineering Controls
  • Containment Culture
  • Process Development
  • Occupational Health Pre-planning
  • Containment Execution Cycle
2.30
2.31
2.32
2.33
2.34

Preparative HPLC Capability in High Potent & Oncology Facilities

Flexible capacity in manufacturing compounds up to Occupational Exposure Limits (OEL) of 1 ng/m³ (full cGMP pilot plant for process scale-up and development, LTSS batches, start-up batches, and full-scale cGMP manufacturing)

With our ability to develop and manufacture APIs, finished dosage Drug Products and Packaging in our network of facilities allows clients full access to integrated services, resulting in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines.