At the moment BioLyo is not GMP certified, but our pilot lyophilizer can be used to generate lyophilized reference material, material to be used in toxicology studies or a variety of other applications. All data generated is generated under a QA system to ensure that all data generated is captured and correct. The capacity of the lyophilizer is approximately 2300 DIN 2R vials, i.e. suitable for relatively small batches of product.
Alternatively, bulk lyophilized material can be generated in Lyoguard trays. The resulting cake can be processed to generate powder that can be used for further processing such as formulation development, filling capsules, vials or another suitable container.
