For several years, our expertise in lyophilisation (freeze-drying) has been used by clients from around the world to assist with the manufacture of investigational bulk intermediates and Active Pharmaceutical Ingredients (APIs) by lyophilisation.
Our facilities enable us to deliver such a lyophilisation service by either aseptic or low bioburden clean room dispensing of up to 100 litres of bulk product per batch. Whether you require a one-off batch or the ongoing bulk lyophilisation of API or finished product, our technical experts can support your supply needs and your product development.
Following the initial sharing of your technical product information pack, a typical bulk lyophilisation project would involve our team taking the bulk intermediate API into our GMP facility prior to transfer into our cleanroom suite. The complexity of this initial stage of the project would very much depend on the needs of the product.
Our team would then proceed to lyophilise the product in appropriate freeze-drying trays. At present, we can accommodate up to 45 standard GORE LYOGUARD trays per cycle or as little as one tray if that meets your needs.
Whether the lyophilisation cycle has been fully developed and is ready to be transferred to us or if there is a need for our team to assist with the development or optimisation of cycle, we are experienced in handling a range of technical lyophilisation challenges successfully.
As with all of the manufacturing services provided by Symbiosis, bulk lyophilisation projects are performed under GMP conditions with Quality Assurance (QA) release of each batch.
Analytical or Microbial Testing
If analytical or microbial testing is required for a batch, we have in the capability to manage this in a highly time-efficient way. Our team can also assist with labelling, controlled temperature storage and distribution of the batches as required.
Operating from an MHRA-licensed manufacturing facility, regulatory compliance and the highest levels of technical capability are at the heart of everything we do.
If you have a specific manufacturing timeline in mind, then we are proud of our ability to be flexible in allocating a dedicated manufacturing slot to your project to ensure your product is manufactured and delivered where, when and how your project demands it.
If you require a specialist manufacturing partner to bulk lyophilise materials for your drug development project, then rest assured you will be in safe hands at Symbiosis. Feel free to contact our team today.