cGMP Aseptic Fill Finish (Liquid or Lyophilization) 2019-07-17T13:22:37+00:00
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cGMP Aseptic Fill Finish (Liquid or Lyophilization)

LSNE has a long track record of success in pre-clinical, clinical and commercial aseptic filling, with hundreds of aseptic batches produced over the past 22 years. We offer a full range of services across three cGMP aseptic fill finish facilities, including everything from process development to analytical testing to packaging.

  • 3 automated aseptic filling lines
  • 2-100 mL vials
  • 0.5-100 mL fill volume/vial
  • Batch sizes up to 35,000 units
  • On-site WFI production
  • Peristaltic pump with low shear
  • 5 aseptic lyophilizers ranging from 36-270 ft.2
  • Aseptic formulation suite
  • Complex formulation experience
  • Lyophilization of organic solvents
  • Secondary packaging services
  • FDA/MHRA inspected

LSNE has three aseptic filling facilities in Bedford, NH and Madison, WI. Standard formulation procedure takes place in an ISO 7 formulation suite using glass carboys, dedicated stainless steel vessels, or multiple-sized LevMix units with temperature control units for high- or low-temperature formulation. With the use of jacketed vessels (up to 200 L) we can maintain the temperature of your product in both the formulation and fill suites between 2°C and 50°C. If a product cannot be sterile filtered or terminally sterilized, we offer aseptic formulation activities for complex products in our dedicated ISO 5 formulation suite.

Our automated fill lines have the flexibility to handle a wide range of vial sizes and fill volumes. Batch sizes can range from several hundred vials to over 35,000, for both liquid and lyophilized presentations. Our multiple-product facility deals regularly with biologics and expensive APIs; we take extreme care at each step to minimize line loss and preserve every gram of material.

We have the experience to provide valuable support and guidance at every phase — including our Process Development and Manufacturing Science & Technology teams that can assist with all stages of development and technology transfer throughout the lifecycle of your product. Our Engineering and Validations teams work together to ensure a smooth scale-up from research and development to clinical and commercial manufacturing, with all of the supporting cGMP documentation.

We maintain a media fill program that supports 2-100 mL vials to keep your product in a validated state. We can perform or manage all QC testing and packaging and labeling activities, including ink jetting on crimp seals.

In short, LSNE can meet all of your aseptic filling needs, eliminating the need for cumbersome tech transfers and ensuring timely, trouble-free delivery.