Liof Pharma Bio Fill & Finish

First-class partner in the field of pharmaceutical contract manufacturing, we use our expertise in Pharmaceutical R&D, Aseptic Filling, Lyophilization, Micro/Nanoencapsulation processes 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 galenic development, preclinical development, production of pilot lots and design of 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 and micro/nanoencapsulation are some 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, semi-automated/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 pharmaceutical contract manufacturing industry incorporating HVAC automatic control, continuous particle monitoring, automatic cleaning, sterilization and other automatic processes and testing.

Our analytical quality control measures include testing raw materials, packaging materials, bulk solutions, in-process materials and finished products. We also offer the design and execution of stability studies.

At Liof Pharma as first-class CDMO partners in drug and medical device manufacturing, we use our expertise in pharmaceutical R&D, aseptic filling and finishing, freeze-drying of biologics (proteins, antibodies, etc.) and small molecules, for the small and medium-scale clinical and commercial manufacturing, while providing extensive knowledge of international requirements to enable your final product to meet the highest quality standards.

We specialize in the manufacture of small and medium-sized clinical batches, our facilities have been strategically designed for this, which allows us to reduce delivery times and the duration of the life cycle. We have experience and knowledge working with the main regulatory authorities, we have our own quality control system that complies with international GMP standards and we are regularly inspected by relevant national and international authorities.

Liof Pharma’s facilities, equipped with the latest technologies, are situated in a thriving biopharmaceutical region close to major research institutions and other relevant partners. We have a flexible, experienced team focused on customer satisfaction, and we have established our own systems for the continuous improvement of processes and procedures in accordance with our operational excellence guidelines.

Liof Pharma Development Service will provide clinical manufacturing expertise from early stage development to market launch, a project manager will carefully coordinate every step to ensure the success of your project.