Our aseptic vial fill finish services take place at four of our five cGMP clinical and commercial manufacturing facilities. We offer both liquid and lyophilized presentations for non-cytotoxic biologics and small molecule parenterals.
Aseptic Vial Filling
With five aseptic automated fill-finish lines to meet your demands, we have the flexibility to sterile fill a range of batch sizes from a few hundred units to 200,000 units. Starting in Q3 2021, LSNE will be expanding its capacity for Phase I and II clinical programs with the addition of a new fill line and lyophilizer. Ideal for batches 5,000 units or less this new ready-to-use aseptic fill line will utilize fully disposable formulation and manufacturing materials and manage in-line weight checks to limit valuable product loss.
Our experience includes:
- Monoclonal antibodies
- Small molecules
|Vial Size||2 – 100 mL||2 – 50 mL||2 – 30R|
|Fill Volume||0.5 – 100 mL||0.5 – 50 mL||0.5 – 30 mL|
|Batch Size||Up to 25,000 units||Up to 30,000 units||Up to 200,000 units|
|Lyophilization Capacity||30 – 270 sq ft||54 – 144 sq ft||150 sq ft|
No matter your batch size or presentation, we will minimize process loss and maximize overall yield of your valuable drug product. Our cGMP fill finish processes are designed to reduce shear stress as much as possible to prevent aggregation / degradation issues. Extreme care is taken to minimize line loss, which is very attractive to our clients developing very expensive API. Our goal is to help get your product to market and in the hands of patients in need.
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.
Take advantage of our in-house GMP analytical testing services to speed turnaround and expedite your timeline.
Controlled Temperature Storage
LSNE offers cGMP validated storage at controlled room temperature, refrigerated and frozen conditions for incoming raw materials and finished product.