Contract Manufacturing Campus in Bedford, NH

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 campus includes headquarters in addition to multi-use and dedicated facilities for sterile fill finish and lyophilization in addition to a QC analytical testing suite

LSNE-Bedford

CORPORATE HEADQUARTERS

23 Commerce Drive Bedford, NH 03110
603.668.5763

LSNE Contract Manufacturing Headquarters and multi-use aseptic fill finish and lyophilization manufacturing facility
Bedford

MULTI-PRODUCT MANUFACTURING

Clinical and Commercial Manufacturing Services

25 Commerce Drive Bedford, NH 03110

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

LSNE Bedford

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

Sundial

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