Principal Scientist Merck and Co Inc Kenilworth, New Jersey
Host cell proteins (HCPs) are process-related impurities that are commonly associated with the development and manufacturing of biopharmaceuticals. If not adequately removed, they can impact the quality, safety, and efficacy of biopharmaceutical products with their immunogenicity, biological activity and/or enzymatic activity. Therefore, it is critical to control residual HCPs in the final drug substance to be within an acceptable limit during the biopharmaceutical manufacturing process. However, despite being a general regulatory expectation to minimize the presence of residual HCPs in final drug product, there is no clear regulatory guidance on the allowable limit, which is often determined on a case-by-case basis taking into consideration of dose, dosage form, route of administration, disease indication, patient population, process capability, preclinical and clinical experience of the product etc. The heterogenic nature and complex composition of HCP impurities, the different analytical methods used to detect and quantify HCPs, and the different modalities where HCP control may be applied make it very difficult to establish a single control limit. In this presentation, I will present cross-modality consideration for HCP control from our experience working on HCP impurity and control in biologics, vaccines, and small molecule chemical drugs synthesized through biocatalytic route. HCP control consideration in cell and gene therapy products will also be briefly touched upon.
Learning Objectives:
Upon completion, participants will be able to describe what are host cell proteins, and their potential impact to patient safety and product quality if not adequately removed during biologics manufacturing process.
Upon completion, participant will be able to learn the different analytical technologies commonly used to detect and quantify residual host cell proteins in biologics drug substance and process intermediates for the purpose of release testing and characterization testing.
Upon completion, participants will also be able to learn some practical considerations for host cell protein control and risk assessment across different modalities that involve biomanufacturing process.
Upon completion, participants will also be able to learn how to leverage the HCP analytics and control strategy developed for biopharmaceuticals and apply them to new modalities such as cell and gene therapy.