IND enabling studies, preclinical development
After selection of the best and most promising pharmacological candidate the next step usually is the preparation of its subsequent testing in human beings.
Clinical trials have to follow strict regulatory rules and guidelines under well defined conditions. Before a new chemical molecule (a new chemical entity, NCE) is tested in humans, extensive toxicological testing in at least two different animal species is required for an assessment of potential adverse effects. Such studies are normally performed by specialized contract research organizations (CROs) under the supervision of the Biotech or Pharma company developing the molecule. Polyphor selects for such studies the premier CROs in the respective field to ensure high quality standards.
Such toxicology studies and the subsequent clinical studies in humans usually require that the study drug is available in the range of several hundreds of grams or even kilograms. Polyphor outsources these larger scale syntheses. The preferred partner is Bachem AG, specialized since decades in the field of peptide synthesis. Polyphor and Bachem have a long-lasting and successful collaboration for such syntheses according to “good manufacturing practice” (GMP).
After manufacturing, the raw chemical material the molecule needs to be formulated, i.e. transformed into a drug that can be given to humans. For Polyphor`s synthetic peptides this formulation is a clear aqueous solution in small bottles for infusions (POL6326, POL7080) or inhalation as aerosols (POL6014). For these formulations Polyphor also collaborates with expert companies in the field.