Aseptically filled vials prepared in trays for lyophilization

Aseptic Fill Finish & Lyophilization

By partnering with LSNE for your aseptic fill finish and lyophilization needs, you are leveraging our versatile 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.

aseptic vial filling

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 life-cycle of the product. LSNE is here for you at every phase. 

With seven aseptic automated 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.

Aseptic formulation suite preparation
Hull lyophilizer for large scale production

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 for manufacturing 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

Pre-filled syringe examined by manufacturing technician

Visual Inspection

After your batch is complete, LSNE’s certified technicians will perform 100% manual visual inspection of the finished product.

Liquid finished vials being passed through line for labeling.

Labeling and Packaging

LSNE can manage your labeling and packaging needs and perform non-blinded clinical labeling, ink-jetting, packaging and kitting.

Scientist at clinical formulation bench

Analytical Testing

Take advantage of our in-house GMP analytical testing services to speed turnaround and expedite your timelines.

Nested prefilled syringes held by manufacturing tech

Terminal Sterilization

We have the capability to terminally sterilize your pre-filled syringes.

ICH stability validated chambers

Controlled Temperature Storage

We have the capability to terminally sterilize your pre-filled syringes.

Scientist at computer

Regulatory Support

We have the knowledge and expertise to support your regulatory submissions through every phase of product development.