GMP services - preclinical /clinacal Batches - Peptides, Small molecules

APIGENEX s.r.o. Offers a wide range of products which includes custom GMP synthesis. Feature: it is syntheses of various organic compounds on a scale of 100 mg to kgs, whether according to known procedures or through the development of new synthetic routes. We also have scale-up capacity, allowing us to produce up to 10 kg of a desired compound. Our service represent a complete package of services associated with technology transfer from laboratory scale to cGMP production. This includes the development and validation of analytical methods for input materials, intermediates, final products, including optimization process and impurity profile. Synthesis and isolation of impurities by preparation of standards, stability studies (long-term and stress), through synthesis and purification (large-volume HPLC) of technical, pilot and validation batches of our own GMP product for use in clinical evaluation, including all necessary documentation.