Company Description:
LSNE is a privately held CDMO with five cGMP facilities; four located in New England and one in Madison, WI. For more than two decades, LSNE has been dedicated to providing comprehensive aseptic fill/finish, lyophilization and development services. LSNE’s proven track record of regulatory execution and compliance, along with the technical expertise and infrastructure allows LSNE to be your end-to-end development and manufacturing partner.
Services & Capabilities:
Aseptic Fill Finish Capabilities
- Preclinical through commercial
- Three automated fill lines; filling, stoppering and crimping in ISO 5 environment
- Batch sizes ranging from a couple hundred vials to 35,000 vials
- Vial sizes from 2 cc to 100 cc
- Peristaltic pump technology for low shear stress processing and minimized line loss
- Six aseptic lyophilizers ranging from 36 ft² to 270 ft²
- Lyophilizers designed to handle organic solvents
- Lyophilizers include redundant compressor and vacuum pump systems to protect high value products
Development Capabilities
- Formulation development, lyophilization cycle development, and accelerated R&D stability
- Extensive experience with proteins, mAbs, peptides, oligonucleotides, and small molecules
- Eight dedicated development lyophilizers
- Developed over 500 lyophilization cycles
- Tech transfer and scale up support available QC Capabilities
- Full QC laboratory to support in-process, release and stability testing
- ICH stability programs
- Analytical method development
- Photostability
Bulk Lyophilization
- Bulk drug intermediates
- 260 ft² lyophilizer
- Up to 400 L capacity
- Disposable Lyoguard trays or dedicated SS trays
- Harvesting options available
Facilities:
LSNE’s five fully integrated cGMP facilities span over 100,000 ft² and can produce drug product and medical devices for preclinical through commercial use.
- 3 Parenteral Drug Product Manufacturing Facilities – 2 located in Bedford, NH and 1 located in Madison, WI
- QC Laboratory located in Bedford, NH
- Medical Device Manufacturing Facility in Manchester, NH