cGMP Aseptic Fill Finish (Liquid or Lyophilization)
LSNE has a long track record of success in supporting our clients’ pre-clinical, clinical and commercial aseptic filling, with hundreds of aseptic batches produced. We offer a full range of services across four cGMP aseptic fill finish facilities, including everything from process development to aseptic fill finish and lyophilization to analytical testing. Our four aseptic filling facilities are located in Bedford, NH, Madison, WI and León, Spain.
- 7 aseptic filling lines for vials, pre-filled syringes and dropper bottles for ophthalmics
- 2-100 mL vials
- 0.5-100 mL fill volume
- Pre-filled Syringes
- 1 mL, 1 mL long, 2.25 mL, 3 mL syringes
- 0.5-3 mL fill volume
- Dropper bottles
- 5 mL and 10 mL bottles
- 0.5-10 mL fill volume
- 8 aseptic lyophilizers capable of handling aqueous solutions and organic solvents
- Batch sizes up to 60,000 units
- On-site WFI production
- Peristaltic pump with low shear
- Aseptic formulation suite
- Complex formulation experience
- Lyophilization of organic solvents
- Secondary packaging services
- FDA/MHRA inspected
Standard formulation procedure using glass carboys, stainless steel vessels, or multiple-sized LevMixTM systems with temperature control units for high- or low-temperature formulation. With the use of jacketed vessels we can maintain the temperature of your product in both the formulation and fill suites between 2°C and 50°C. If a product cannot be sterile filtered or terminally sterilized, we offer aseptic formulation activities for complex products in our dedicated aseptic formulation suite.
Our automated fill lines have the flexibility to handle a wide range of vial-syringe-dropper bottle sizes and fill volumes. Batch sizes can range from several hundred vials to over 35,000, for both solutions and suspensions, as well as liquid and lyophilized presentations. Our multiple-product facilities deal regularly with hormones, steroids, small molecules, biologics and high value active pharmaceutical ingredients (APIs); we take extreme care at each step to minimize line loss and preserve every gram of material.
We have the experience to provide valuable support and guidance at every phase — starting with our Process Development and Manufacturing Science & Technology teams that can assist with all stages of development and technology transfer throughout the lifecycle of your product. Our Engineering and Validations teams work together to ensure a smooth scale-up from research and development to clinical and commercial manufacturing, with all of the supporting cGMP documentation.
We can perform or manage all QC analytical testing and packaging and labeling activities, including ink jetting on over seals.