Bulk Lyophilization
With more than twenty years of experience in freeze-drying bulk products, LSNE can efficiently and expertly handle large-scale bulk lyophilization, harvesting, and packaging of your medical device, drug intermediate or API.
Endless Bulk Freeze-Drying Possibilities
LSNE offers flexible bulk lyophilization services across three cGMP facilities. Our bulk freeze-drying capacity ranges from a few trays in a small scale lyophilizer up to 260 ft2 lyophilizer that can accommodate up to 195 disposable Lyoguard® trays.
For long term savings, we can design and fabricate dedicated reusable stainless steel lyophilization trays to maximize the throughput of each freeze-drying cycle.
Procuring dedicated trays will require cleaning method development and validation and can greatly reduce the repeated costs of procuring disposable trays for each individual production run. Additionally, we have a proven record of shortening and optimizing lyophilization cycles to reduce costs over a product’s lifespan.
Harvesting
If bulk lyophilization is an intermediate process step within your supply chain, we can efficiently transfer the bulk freeze-dried product to you, or eliminate the need for a tech transfer to a different CMO by utilizing LSNE for fill finish in vials, prefilled syringes or dropper bottles.
For bulk lyophilization processes that use disposable Lyoguard® trays, we can easily package the freeze-dried trays into pouches in preparation for further processing. Should your process need dedicated trays, we can work with you to design a process to harvest the lyophilized material, and if required, utilize containment systems for the harvesting of more-potent compounds.
Solvent Lyophilization
If your formulation process requires the use of organic solvents, such as tert-butyl alcohol, acetonitrile, DMSO or ethanol, we have experience with developing and transferring the manufacturing processes to our GMP facilities. We work closely with our Mechanical and Environmental Health and Safety teams to fully understand the maximum volumes we can safely handle.
Client Success
Senior Director of Operations for Mid-Sized Pharmaceutical CompanyLSNE really works with its clients, not all CMO’s are willing to do that.