First-class partner in the field of pharmaceutical contract manufacturing of medicinal products and medical devices, we use our expertise in Pharmaceutical R&D, Aseptic Filling, Lyophilization and extensive knowledge of international requirements to enable your product meets the most demanding quality standards and customer needs. Liof Pharma offers development and preclinical supply services including flexibility on the manufacturing of small batch size pilot lots for preclinical trials for efficacy, safety as well as other complementary studies for technology scale up. We have extensive experience working with complex substances such as biologics, including monoclonal antibodies, peptides and other proteins. Lyophilization is one of our areas of expertise. Knowing how to design an appropriate manufacturing process is critical for both regulatory and efficiency purposes. Clinical manufacturing (Preclinical, Phase I, Phase II, Phase III) service is offered using NoncGMP/cGMP, semiautomated/automated filling processes matching all the customer needs. Manufacturing steps include sterile filtration, preparation of primary packaging materials (e.g., cleaning, sterilization), preparation of the formula and lyophilization if required – primarily biologics such as proteins and monoclonal antibodies. We have extensive knowledge manufacturing sensitive, high-value biologics and aseptic processing. Our aseptic filling technologies and lyophilization methods meeting the latest state-of-the-art are among the most advanced in the medicinal product and medical devices contract manufacturing industry incorporating HVAC automatic control, continuous particle monitoring, automatic cleaning, sterilization and other automatic processes and testing. Our analytical quality control capacities are focus on testing of raw materials, packaging materials, bulk solutions, in-process controls and finished products for lot release, according to Eur. Ph. or international Pharmacopoeias.