Injectable Drug Manufacturing
Source: Lifecore Biomedical
From the production floor to the shipping door, your unique clinical or commercial requirements will be fulfilled at each step of the process.
Lifecore’s experts have gained the know-how to build processes around your requirements for smooth scale-up and high-quality manufacturing. Whether we’re your primary partner or a secondary source for manufacturing, we ensure you’re fully satisfied with the final product that bears your brand.
Fill and Finish Capabilities
Formulation – ISO 7 (Grade C)
- Sterile and non-sterile formulation
- Highly viscous solutions
- Chemical transformations, hydrogel cross-linking, and purification unit operations, all under sterile conditions
- Standard and custom Krieger and DCI mixing equipment
Filtration – ISO 7 (Grade C)
- Sterile filtration capability of highly viscous materials in excess of 100,000 cP
- Filtration into sterile containers for bulk material shipment, or intermediate vessels for filling
Filling – ISO 5 (Grade A)
Aseptic filling for multiple sizes and configurations of vials, syringes, and cartridges.
- Flexicon Vial Filler (2R-100R) – Peristaltic Pump
- Optima 5-Head Syringe Filler for 0.5mL – 10mL, Rotary Piston Pump
- Optima 5-Head Flex Filler – 0.5mL – 10mL syringes or 2mL – 50mL vials, Rotary Piston Pump
- Groninger in SKAN Isolator 5-Head Flex Filler – GMP-ready Q2 2024
- Groninger in SKAN Isolator 10-Head Flex Filler – GMP-ready Q2 2025
- COLANAR – Benchtop Pilot filler for scalable fill parameter optimization
Packaging, Handling, Sterilization
- Supply chain expertise to identify, source, and procure all raw materials
- Assistance with non-standard components such as enhanced plunger rods or ergonomic finger grips
- Ambient and cooled storage for incoming raw materials and finished products
- Label development
- Automated labeling (PFS)
- Automated plunger rod insertion
- Automated flange extender application
- Customized syringe components
- Trays (blisters), pouches
- Secondary sterilization via 3rd party
- Cartoning
- Single unit and bulk packaging
- Final product labeling and serialization
Lifecore Biomedical
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