The Biosimilars Alliance – leverage 20 years of biologics drug development experience to enable early assessment viability of biosimilars, and bridge the gap between newly sourced products and patient studies.
Celerion has partnered with Ricerca Biosciences to form “The Biosimilars Alliance” and bring together the specific expertise required to guide clients through the complex development process.
• Early safety and PK assessment of biologic drug candidates in animals and humans
• Extensive experience in assays of human insulins, interleukins, interferons, pegylated interferons, erythropoetins, monoclonal antibodies and fusion proteins
• Immunotoxicology expertise within Europe’s largest Non Human Primate (NHP) research facility
• Extensive expertise in the monitoring and quantification of antigenicity (anti-drug antibodies) in animal and human samples from clinical studies
• PK/PD assessment of biological products in patients and healthy volunteers
• Regulatory expertise to guide full biosimilar development programs
• Full program development leadership and/or ad hoc consulting services spanning preclinical to pivotal clinical studies