Bulk Lyophilization

Source: PCI Pharma Services

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 include:

  • Bulk Freeze-Drying

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 lyophilizer, 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 and provide long-term savings.

  • 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 technical transfer to an 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.

  • Solvent Lyophilization

If your manufacturing process requires the aid of organic solvents to increase solubility, we can evaluate such solvents as tert-butyl alcohol, acetonitrile, DMSO, or ethanol. We work closely with our Environmental Health and Safety team to fully understand the maximum volumes we can safely handle.