Injectable Drug Manufacturer | Fill Finish | Clinical to Commercial Scale Up

Manufacturing that flexes
to fit unique needs.

Never a one and done.

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, fill volumes up to 100mL
Optima INOVA Filler (5 Head Syringe Filler- 0.5mL – 10mL) – Rotary Piston Pump (2 Machines Available); fill volumes up to 10mL
Optima INOVA Filler (5 Head Flex Filler – 0.5mL – 10mL syringes or 2mL – 50mL vials) – Rotary piston pump
Groninger in SKAN Isolator Filler (5 Head Flex Filler) – 2023 installation
Groninger in SKAN Isolator Filler (10 Head Flex Filler) – due 2024
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, pouches
Secondary sterilization via 3rd party
Cartoning
Single unit and bulk packaging
Final product labeling and serialization

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; fill volumes up to 100mL
Optima INOVA Filler (5 Head Syringe Filler- 0.5mL – 10mL) – Rotary Piston Pump (2 machines available); fill volumes up to 10mL
Optima INOVA Filler (5 Head Flex Filler – 0.5mL – 10mL syringes or 2mL – 50mL vials) – Rotary piston pump
Groninger in SKAN Isolator Filler (5 Head Flex Filler) – arriving Q4 2023; GMP-ready Q2 2024
Groninger in SKAN Isolator Filler (10 Head Flex Filler) – arriving Q1 2024
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