Medical Device Manufacturing & Lyophilization
LSNE has over 20 years of experience in the manufacture and lyophilization of a wide range of medical devices. With two licensed cGMP facilities that support medical device manufacturing, we’re built from the ground up to provide low cost and reliable production for all of your medical devices products.
- Formulation and filling of viscous solutions and slurries
- Collagen processing and lyophilization for collagen bandages, strips, putty, etc.
- Thermal and chemical crosslinking options available
- Milling and grinding
- Non-aseptic fill finish and lyophilization in vials and syringes
- 10 cGMP lyophilizers across 2 facilities, ranging from 30-260 ft.²
- Equipment for formulating/processing including overhead/shear mixers
- Packaging including sealing into blister trays or pouches
- Final packaging including labeling and kitting
- FDA inspected; 3rd-party audited
- Regulatory support for 510(k), PMA and CE Mark submissions
By partnering with more than fifty medical device clients over more than two decades, LSNE has developed the knowledge and the capacity to offer a flexible approach to medical device manufacturing. With two non-aseptic medical device manufacturing facilities located in New Hampshire, we have extensive experience supporting both small and large companies, from virtual startups to some of the largest medical device companies in the world.
We have particular expertise in the lyophilization and processing of collagen-based medical devices for a variety of indications including spinal, dental, orthopedic, dural repair, tendon repair and nerve repair. LSNE is the partner you can rely on to complete a successful technology transfer, and our in-depth knowledge of collagen processing can help you optimize your manufacturing process no matter what stage your product is in.
We can also partner with you on your non-aseptic fill/finish and lyophilization needs for products that are formulated and filled into vials or syringes. LSNE’s non-aseptic fill/finish projects are supported by 10 GMP lyophilizers dedicated to medical device manufacturing. Our team ensures rigorous quality oversight, and we have in-house resources to support designing, fabricating, sourcing and validating client-dedicated equipment. We work directly with our clients to optimize batch sizes based on clinical/commercial needs and have proven our ability to support technology transfers to our cGMP FDA-inspected facilities through scale up for later stage products, process validation and commercial launch.