Aseptic Fill Finish & Lyophilization
By partnering with LSNE for your aseptic fill finish and lyophilization needs, you are leveraging our versatile contract manufacturing capabilities and successful regulatory history. No matter your batch size or presentation, we will make every effort to minimize process loss and maximize the overall yield of your valuable drug product. Our goal is to help get your product to market and in the hands of patients in need.
Our clients help patients. We help make it happen.
Clinical and Commercial Fill Finish
We work in harmony with our clients at every step of the manufacturing process, from early development through the entire lifecycle of the product. LSNE is here for you at every phase.
With seven automated aseptic fill finish lines to meet your demands, we have the flexibility to sterile fill a range of dosage forms with batch sizes from a few hundred units up to 60,000 units. We have a solution for whatever your manufacturing needs may be.
Formulation
Our standard aqueous formulation process takes place in an ISO 7 or Grade C controlled environment. Based on your product’s unique characteristics we can employ the use of:
- Glass Carboys
- Stainless Steel Vessels
- Disposable Biobags
Temperature Control
When products are heat sensitive and require cooling or need to be warmed to fully solubilize the API, LSNE can provide tight temperature control with one of our temperature control units and jacketed vessel options. We can maintain the temperature of your product between 2°C and 50°C during both formulation and filling.
Complex Formulation
LSNE has experience with a wide variety of novel drug products and complex formulations, such as polymer nanoparticles and Lipid Nanoparticles (LNPs). If your product cannot be sterile filtered or terminally sterilized, we can develop and qualify an aseptic formulation process in our dedicated ISO 5 aseptic formulation suites.
Clinical and Commercial Lyophilization
We understand you are placing an extreme amount of trust in us to deliver your drug product.
LSNE works with many high value APIs and we have designed our freeze-dryers with redundant vacuum pumps and compressors to increase reliability during the lyophilization of every lot of your precious drug product.
Our eight aseptic GMP lyophilizers range from 36 ft² to 270 ft² and are capable of freeze-drying aqueous solutions and organic solvents. With over thirty lyophilizers across our global network, we have the capacity to meet your clinical and large-scale commercial demands.
Manufacturing Support
Visual Inspection
After your batch is complete, LSNE’s certified technicians will perform 100% manual visual inspection of the finished product.
Labeling and Packaging
LSNE can manage your labeling and packaging needs and perform non-blinded clinical labeling, ink-jetting, packaging and kitting.
Analytical Testing
Take advantage of our in-house GMP analytical testing services to speed turnaround and expedite your timelines.
Terminal Sterilization
We have the capability to terminally sterilize your pre-filled syringes.
Controlled Temperature Storage
We have the capability to terminally sterilize your pre-filled syringes.
Regulatory Support
We have the knowledge and expertise to support your regulatory submissions through every phase of product development.
Client Success
Director of CMC for Mid-Sized Pharmaceutical OrganizationThey’re extremely good at what they set out to do. I don’t think they’d take anything on if they didn’t think they could be perfect at it.
Here for You at Every Phase
Our flexibility and GMP framework positions LSNE to support early clinical as well as commercial projects.