Biopharma Group’s freeze drying set-up is designed for flexibility in terms of size, type, duration and scheduling of processing runs. This flexibility has proven ideal for start-ups or smaller organizations whose manufacturing runs are not yet large or consistent enough to justify the capital expense of onsite production facilities. It also provides an ideal fall-back capability for those whose existing manufacturing capabilities become temporarily insufficient, in the event of sudden large orders or equipment failure.
Our production freeze drying capabilities are also utilized by customers whose development work has just been completed by Biopharma. This provides an immediate production capability, particularly useful where equipment has not been purchased or alternative arrangements have not yet been finalized. It also enables the product and process to be road-tested under expert scrutiny.
Biopharma has several pilot-scale freeze dryers with which we are able to perform freeze-drying runs on a contract basis. Our lyophilizers feature shelf area of 0.5m2—1.42m2 each and up to 35 litres condenser capacity. This would allow, for example, ‘1760 10ml ‘DIN10’ vials, or 2112 5ml ‘DIN6’, or 5016 2ml ‘DIN2’ vials to be processed in one machine at a time. Stoppering and backfill is available where required. PC control also provides in-cycle monitoring and post-process analysis.
We are able to handle small molecules, nucleic acids, proteins, bacteria and biomaterials. We also able to provide the necessary containment for genetically modified organisms (GMOs). We have a separate standalone facility with dedicated equipment to allow us to handle cytotoxic products. Filling and labelling services are also available, as well as post-process moisture analysis and validation.