With more than twenty years of experience in freeze-drying bulk products, PCI is able to efficiently and expertly handle large-scale bulk lyophilization, harvesting, and packaging of your medical device, drug intermediate or API.
Our Bulk Lyophilization Services
We offer 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 l, able to accommodate up to 195 disposable Lyoguard® trays. We can design and fabricate dedicated and reusable stainless steel lyophilization trays to maximize the throughput of each freeze-drying cycle.
Procuring dedicated trays will require cleaning method development and validation while reducing the overheads of disposable trays for each individual production run. Additionally, we have a proven record of shortening and optimizing lyophilization cycles.
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 technical transfer to a alternative CDMO by utilizing our abilities 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 require 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.
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 cGMP facilities working closely with our Environmental Health and Safety (EHS) teams to fully understand the maximum volumes we can safely handle.