Injectable Drug Manufacturing

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