Excipients for solubilization and aggregation issues
Therapeutic Biological Products, such as monoclonal antibodies, are a growth driver of the pharmaceutical industry. Unfortunately, biological formulations raise several challenges, including aggregation and solubilization issues for proteins.
Challenges in the formulation of biological products
Aggregation has emerged as a major issue for biological formulations, underlying multiple deleterious effects, including loss of efficacy and unwanted immunogenicity.
Additionnaly, a rising number of therapeutic biological drugs currently in preclinical or clinical development for injectable administration are poorly water soluble. SEPPIC addresses these issues with its range of high quality standard surfactants specifically dedicated to parenteral use, the MONTANOX™ PPI.
SEPPIC has also developed an innovative excipient that offers a breakthrough alternative, SEPICLEAR™ 01 PPI.
SEPPIC excipients are manufactured with the same high quality standards as for Active Pharmaceutical Ingredients. They comply with Good Manufacturing Practices (GMP Part II) and current pharmacopoeias.