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 works with several external vendors to form “The Biosimilars Alliance” and bring together the specific expertise required to guide clients through the complex development process.
- This includes:
- Extensive experience in assays of human insulins, interleukins, interferons, pegylated interferons, erythropoetins, monoclonal antibodies and fusion proteins
- Extensive expertise in the monitoring and quantification of antigenicity (anti-drug antibodies) in samples from animal and human clinical studies
- PK/PD assessment of biological products in patients and healthy subjects
- Regulatory expertise to guide full biosimilar development programs
- Full program development leadership and/or ad hoc consulting services spanning preclinical to pivotal clinical studies