New Hampshire
Just an hour north of Boston, LSNE was founded in the Granite State and we have built a campus, through organic growth, that meets a versatile set of pharmaceutical development and manufacturing capabilities.
LSNE-Bedford
CORPORATE HEADQUARTERS
23 Commerce Drive Bedford, NH 03110
603.668.5763
MULTI-PRODUCT MANUFACTURING
Clinical and Commercial Manufacturing Services
25 Commerce Drive Bedford, NH 03110
- Clinical labeling, ink jetting and packaging services
- Commercial labeling, packaging and serialization – third part management
CAPABILITIES
- Established in 2009
- cGMP manufacturing initiated in 2011
- Drug product manufacturing of biologics & small molecules
- Medical device manufacturing
- Batch sizes of hundreds of units up to 20,000 vials (liquid/lyophilized)
- FDA & EU commercial products
- Type V Drug Master File (DMF)
- Formulation volumes up to 200 L; custom configurations available
- On-site WFI production
- Peristaltic pump for low shear product transfer and filtration of sensitive products
- Complex formulation including ISO 5 or Grade A formulation suite
QC LABORATORY & CENTRALIZED WAREHOUSE
7 Commerce Drive Bedford, NH 03110
CAPABILITIES
- Established in 2018
- cGMP raw material and finished product testing
- In-process, release and stability testing
- Phase appropriate method validation
- Validated storage
- Stability protocol development and management
19 Harvey Road
COMMERCIAL ASEPTIC FILL FINISH & LYOPHILIZATION FACILITY
The Harvey Road facility commercially manufactures a lyophilized aseptic drug product for the US market since 2011.
29 Harvey Road
COMMERCIAL ASEPTIC FILL FINISH & LYOPHILIZATION FACILITY
The NEW Harvey Road facility will manufacture the same commercial product as the original Harvey Road site, however, the new facility is designed to meet Rest of World (ROW) requirements. This new Harvey Road site will supply global demand of our client’s lifesaving technology. Process validation is set to begin in Q4 2020.
LSNE-Manchester
Medical Device Manufacturing Facility
Commercial Manufacturing Services
1 Sundial Avenue, Manchester, NH 03103
CAPABILITIES
- Established in 1997
- Diagnostic filling and lyophilization
- Collagen device processing/manufacturing
- Batch sizes up to 15,000 units (liquid/lyophilized)
- Primary and secondary packaging
- Lyophilizers ranging from 4 ft2 to 180 ft2
- An on-site purified water system
- Peristaltic pump technology
- Labeling and packaging services
- Class I, II, III and CE Mark devices
- FDA & ANVISA Inspected
- Several Notified Body Inspections
