Claudia Mueller
F Hoffmann La Roche, Switzerland
Title: Development of co-formulations of monoclonal antibodies and recombinant human hyaluronidase (rHuPH20)
Biography
Biography: Claudia Mueller
Abstract
For patients, subcutaneous (SC) administration represents a convenient alternative to i.v. infusion. However, SC application faces limitations with regards to the drug volume that can be administered. To enable delivery of the necessary doses, increase in the concentration of the drug and/ or temporary enlargement of the interstitial space at the injection site, e.g. by using recombinant human hyaluronidase (rHuPH20), are potential strategies to face this challenge. This presentation highlights the technical development approaches used at Roche for the drug product development of co-formulations consisting of concentrated monoclonal antibodies and rHuPH20. The presentation will focus on particular challenges for formulation and process development arising from combination of two very different proteins in order to maintain both stable and active within one formulation.