LSNE has a long track record of success in pre-clinical, clinical and commercial aseptic filling, with hundreds of aseptic batches produced over the past 20 years. We offer a full range of services across three cGMP aseptic fill finish facilities, including everything from process development to analytical testing to packaging.
- 3 automated aseptic filling lines
- 2-100 mL vials
- 0.5-100 mL fill volume/vial
- Batch sizes up to 35,000 units
- On-site WFI production
- Peristaltic pump with low shear
- 5 aseptic lyophilizers ranging from 36-270 ft.2
- Aseptic formulation suite
- Complex formulation experience
- Lyophilization of organic solvents
- Secondary packaging services
- FDA/MHRA inspected
LSNE has three aseptic filling facilities in Bedford, NH and Madison, WI. Standard formulation procedure takes place in an ISO 7 formulation suite using glass carboys, dedicated stainless steel vessels, or multiple-sized LevMix units with temperature control units for high- or low-temperature formulation. With the use of jacketed vessels (up to 200 L) 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 ISO 5 formulation suite.
Our automated fill lines have the flexibility to handle a wide range of vial sizes and fill volumes. Batch sizes can range from several hundred vials to over 35,000, for both liquid and lyophilized presentations. Our multiple-product facility deals regularly with biologics and expensive 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 — including 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 maintain a media fill program that supports 2-100 mL vials to keep your product in a validated state. We can perform or manage all QC testing and packaging and labeling activities, including ink jetting on crimp seals.