For several years, our expertise in 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). More recently we have developed the ability to freeze dry bacterial cultures to deliver lyophilised Live biotherapeutics in cGMP for our customers clinical trials.
We have a dedicated small-scale freeze dryer used for development work and a self-contained freeze-drying unit which is operated and maintained according to current TGA guidelines for GMP work. They can be operated in both aerobic and anaerobic mode thereby allowing us maximum flexibility when freeze drying a live biotherapeutic microorganism.
Our development freeze dryer closely mimics the behaviour of our Stokes GMP freeze dryer and allows us to investigate and develop cost effective and efficient lyophilization protocols. We can investigate a number of cryopreservatives and temperature profiles which allows us to target moisture contents well below 5%.
For the lyophilisation of API’s our facilities enable us to deliver such a lyophilization service by either aseptic or low bioburden clean room dispensing of up to 32 litres of bulk product per batch. This can then be transferred to a fill finish facility for sterilization.
For our Live biotherapeutics projects we can lyophilise the bacteria in both aerobic or strict anaerobic conditions. The anaerobic conditions have an atmosphere which can be proven to be consistently under 100ppm Oxygen. Together with our skill in choosing the right cryopreservative and developing the appropriate lyophilization profile this allows us to offer viabilities of between 15% and 85% of the original culture. This reduces the amount of culture needed and therefore positively influences the viability of the project.
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.