Lifecore Biomedical

Lifecore Biomedical partners with pharmaceutical and biotech companies to manufacturer difficult to formulate and fill injectable drug products for clinical trials and commercial production that help improve patient lives. Our expertise stems from decades of experience manufacturing highly viscous pharmaceutical grade sodium hyaluronate.Lifecore Biomedical is the global leader in manufacturing and supplying sodium hyaluronate (NaHy) for highly viscous injectable drug products. Over the past 30 years, more than 90 million patients have benefited from our certified pharmaceutical grade NaHy. Now we are using our expertise to expand our contract development and manufacturing services to solve the most complex drug development challenges.Development• Formulation and Process Development• Analytical Method Development• Stability Testing• Technology Transfer• Equipment Design and Procurement• Pilot Batch Sizes for Syringe and Vial Configurations• Quality Systems Experience in Pharmaceutical and Medical Device Regulations• Regulatory SupportClinical and Commercial Manufacturing• Formulation• Sterile Filtration of Highly Viscous Solutions• Aseptic Filling into Syringes or Vials• Secondary Sterilization• Final Packaging• Global Supply Chain Management• Large, Efficient Batch SizesPharmaceutical and Research Grade Sodium Hyaluronate• Hyaluronan is a physiological substance that is widely distributed in the extracellular matrix of connective tissues in both animals and humans. • Lifecore’s sodium hyaluronate is produced by an efficient microbial fermentation and purified by a highly effective purification process. It is produced in large batches to promote consistency in supply and customer convenience. • Pharmaceutical grade sodium hyaluronate is available as a powder in a broad range of molecular weights for use in various medical applications (150KDa – 1.8MDa). Sterile pharmaceutical grade sodium hyaluronate is available in select molecular weights.• Primary medical applications include: Ophthalmology, Orthopedics, Aesthetics, Tissue Engineering, and Veterinary Medicine Our robust Quality System has been forged from our extensive experience with producing drugs and medical devices for a diverse group of partners over the last 25 years. We continue to learn from our industry partners and global regulatory authority audits to improve and implement best practices in our Quality System.The Lifecore facilities are US FDA Drug and Device Registered and have GMP (EU, Japan, and Brazil) and EN ISO 13485 certifications. Our facilities are conveniently located in the central United States just outside of Minneapolis, Minnesota.