Medical Device Manufacturing & Lyophilization
With two licensed facilities that support non-aseptic fill finish and lyophilization, we’re adept at providing low cost and reliable production. LSNE has over twenty years of experience manufacturing a wide variety of medical devices and will work with you to optimize batch sizes for your clinical and commercial needs.
Medical Device Manufacturing
LSNE specializes in commercial production of diagnostics, collagen and biomaterial sponges, resorbable implants, wound healing and tissue engineering applications, and more. We have proven our ability to support technology transfers from our development labs to our cGMP FDA inspected facilities through scale-up and process validation. Efficient technology transfers and rapid batch release allow for a streamlined pathway to commercialization.
- Formulation and filling of solutions and viscous slurries
- Non-Aseptic fill finish and lyophilization of vials and syringes
- Expertise in collagen processing and lyophilization
- Thermal and chemical crosslinking
- Milling and grinding
- Primary and secondary packaging
LSNE can formulate aqueous solutions as well as viscous slurries. We have a variety of formulation vessels and mixing technologies that can be utilized to formulate your raw materials prior to filling and lyophilization, and if temperature control is required, we can maintain the temperature of your product throughout the formulation and filling process.
Vial and Syringe Filling and Lyophilization
LSNE has three automated non-aseptic fill-finish lines which can fill vials and syringes in quantities up to 15,000 units per batch. We utilize peristaltic pump technology to fill aqueous solutions and positive displacement pumps for viscous slurries such as chitosan or cellulose materials. Our cGMP non-aseptic freeze-drying capacity ranges from 30 ft² to 260 ft² across ten lyophilizers.
Collagen and Biomaterials Processing
We have expertise in formulating and lyophilizing collagen and biomaterials for a variety of indications including:
- Wound care
- Dural repair
- Tendon repair
- Nerve repair
We utilize either disposable or dedicated stainless steel trays and molds for lyophilizing collagen or biomaterial-based materials to maximize the yield of each batch.
We work with our clients to develop a variety of thermal and chemical crosslinking processes to strengthen the collagen devices we manufacture
LSNE can mill your lyophilized material as an intermediate step of the manufacturing process to facilitate further processing of the milled material.
Our services labeling and kitting, heat sealing pouches and custom blister trays with Tyvek® lids, final kitting with product specific cartons, labels, gamma indicators and more.