Ascil Biopharm | ASCIL Biopharm

1. Formulation, Process & Device Department

• Expertise in Controlled Release Formulations (CRF) and Ultra High Compositions (UHC) for small molecules, peptides, and biologics such as proteins or monoclonal antibodies (mAbs).
• Preformulation and formulation development to create ready-to-use (RTU) solutions tailored to specific needs.
• Platform technology for analyzing physicochemical properties of APIs and excipients, supporting the development of various technologies: In situ forming or pre-formed depot implants, highly concentrated suspensions, aqueous compositions, hydrogels, biodegradable implants and microparticles, and very low molecular weight polymers.

2. Analytical and Phy-Chem Department

• Stability studies and quality control during the development process.
• Advanced analytical characterization of formulations.

3. GMP Pilot Plant: Production of GMP clinical batches for Phase 1 and Phase 2.

• Freeze-dried products (aseptic process).
• Small volume liquids (terminal sterilization and aseptic process).
• Semisolids (terminal sterilization).
• Process scaling and validation for formats such as vials, syringes, and cartridges.

4. Regulatory, QA, and Clinical Department

• GMP Oversight: Management of activities, batch release, and regulatory authority interactions.
• Quality Assurance: Quality system management and internal/external audits.
• Clinical Support: Documentation management, clinical trials, and coordination with CROs.