Asymchem Inc

Injectables

Injectables

Reliable Clinical Supply, Rigorous Sterility Assurance

From pre-formulation, formulation design, process development and clinical supplies to commercial production of sterile solution and sterile lyophilized powder, Asymchem is ready to help. We specialize in the solubilization of poorly soluble drugs as well as sterilization either by aseptic processing or by terminal sterilization. We can deliver the final drug product in vials or ampoules, depending on the best option for your API and intended use. Our first-in-class integrated sterility and quality assurance systems can fully support your supply manufacturing quality and GMP compliance. In addition, our state-of-the-art analytical lab enables us complete in-house testing capability including microbial and particulate testing, as well as extractable and leachable testing for material compatibility.

Dosage Forms

• Sterile injections in ampoules or vials
• Sterile lyophilized powders in vials

Technology Platform

• Solubilization of poorly soluble drugs
• Development and optimization of lyophilization process cycles
• Development and evaluation of sterilization method
• Residual oxygen control in headspace of container
• Injectable formulation development for high potent APIs

Equipment Capacities

• Three injectable production lines
• Up to 66,000 units per batch
• Different injectable dosage forms from pre-IND, phase 1 and 2, and commercial stages can be manufactured
• Automatic compounding systems with on-line CIP/SIP
• Filling and sealing machine with online automatic sampling, pre- and post- nitrogen filing
• Mini KuFill sterile isolator with filling, freeze drying and capping