For several years, our expertise in bulk lyophilization (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 lyophilization.
Our facilities enable us to deliver such a lyophilization service by either aseptic or low bioburden clean room dispensing of up to 100 liters of bulk product per batch. Whether you require a one-off batch or the ongoing bulk lyophilization 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 lyophilization 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 lyophilize 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 lyophilization 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 lyophilization challenges successfully.
As with all of the manufacturing services provided by Symbiosis, bulk lyophilization service is 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 in Europe, 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 lyophilize materials for your drug development project, then rest assured you will be in safe hands at Symbiosis. Feel free to contact our team today.