Lyophilization Services of New England, Inc.

LSNE Contract Manufacturing is a privately held company with three manufacturingfacilities located in New England. LSNE has been providing cGMP services to thepharmaceutical, biotechnology and medical device industries since 1997; specializing in a wide range of services including process development, fill/finish and lyophilization. With on-site development services, we canpartner with our clients to optimize their current formulation and lyophilization cycle or develop a cycle from scratch and perform the necessary feasibility work. Once development activities are complete, LSNE can formulate, fill, lyophilize and package finished products. Our highly skilled personnel coupled with our automated equipment, work to provide consistent, quality material. LSNE offers both the flexible approach commonly required with preclinical projects, as well as the cGMP framework necessary for late stage clinical and commercial manufacturing. Specializing in the production of high-quality small to medium size batches, LSNE is perfectly suited for orphan indications or products with modest annual volumes. Our experienced development, operations, quality and project management teams work in unison to evaluate our client’s project objectives and recommend an optimal path forward to achieve easier regulatory submissions and a faster time to market.

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Locations


United States
LSNE Contract Manufacturing
25 Commerce Drive
Bedford, NH  03110
United States, North America

GMP Experience
Aseptic Fill/Finish & Lyophilization, Bulk Lyophization, Medical Device Manufacturing, Process Development, ICH Stability Studies Established in 2011 Producing clinical and commercial product
United States
LSNE Contract Manufacturing
19 Harvey Road
Bedford, NH  03110
United States, North America

GMP Experience
Aseptic Fill/Finish and Lyophilization Established in 2005 Producing clinical and commercial product
United States
LSNE Contract Manufacturing
1 Sundial Avenue
Manchester , NH   03103
United States, North America

GMP Experience
Medical Device Manufacturing Established in 1997

Contacts


Christine Palus
VP of Sales & Marketing
Katie Chase
Senior Sales Associate
Jeff Clement
Director, Business Development

Production Lines

LSNE Contract Manufacturing   Aseptic Liquid Filling
Location: Bedford, NH, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  20,000-50,00020,000-50,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
Supported Vial Size:  20+ ml20+ ml
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 02JUN17

Send Inquiry about this Production Line
LSNE Contract Manufacturing   Aseptic Lyophilization
Location: Bedford, NH, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LyophilizedLyophilized
Batch Size:  20,000-50,00020,000-50,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
Supported Vial Size:  20+ ml20+ ml
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 02JUN17

Send Inquiry about this Production Line

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