Enhancing Specificity and Efficiency
HCPs are process-related impurities clearly being considered as critically relevant and undesirable in the final drug substance. By their very nature, HCPs have the potential to provoke destructive reactions within the Drug Substance and/or to elicit an immune response in humans. However, current bioprocess technologies cannot produce absolutely HCP-free material from a living organism like commonly used Chinese Hamster Ovarian cell cultures (CHOs). Determining not only the quantity but also the identity of HCPs during any biopharmaceutical’s production is of utmost importance for patient safety and massively influences the product’s approval timelines. The application of MS to the detection and identification of HCPs significantly enhances the specificity and efficiency of your testing methods and minimalizes the risk of critical HCPs in the final product to an acceptable level.
Guidelines Mirror Growing Sensitivity
Undetected HCPs can have serious effects on a product’s character ranging from lipase and endoprotease activities or protein denaturation to unwanted immune responses and other direct impacts on the patient. Health authorities, knowing about the importance of evaluating HCPs, have been developing a growing sensitivity for HCP monitoring within the last few years, not least because of recent incidents having led to the complete withdrawal of clinical studies. The fundamental issue thus lies in establishing the best possible risk management based on an adequate 1. measurement, 2. monitoring, and 3. control of HCPs. Relevant guidelines, like USP, EP, and ICH, demand the highest possible degree of control for best detection and purification results.
Detection and Understanding: Increase Your Product’s Safety by Means of an Encompassing MS-based Risk Management
Most protagonists within the biotechnology industry currently use a combination of ready-made and customized ELISA immunoassays in order to reveal unwanted critical HCPs. Although these black box assays, based on the detection of antibodies, can come very close to it, they will provide neither a guarantee for an all-embracing disclosure nor for a complete understanding of process-related impurities. In order to fill the gaps to a complete detection and understanding of HCPs, an unbiased approach is necessary. PPS thus encourages you to apply MS technology in addition to the established immunoassay approaches to judge the safety of existing HCP control strategies.
Mass spectrometry can be widely applied and straightforwardly adjusted to different HCP related issues during product development.
As HCPs do not have to be known prior to analysis, mass spectrometry is the most reliable technology to meet up with the regulatory request for the application of orthogonal methods in the process of purifying the biological product from any cell-based impurities to a tolerable level before approval.
Dr. Thomas Flad, Head of Business Development
Most importantly, PPS has recently successfully identified and quantified HCP within several late stage development candidates and thereby substantially supported approval processes.
Protagen Protein Services partners you in establishing a comprehensive understanding of your product’s nature from harvest to approval. Applying mass spectrometry at an early stage as an additional tool to ELISA testing methods will significantly accelerate your product’s release process and enhance its chance of success. See also our service section HCP Analytics.
We will be happy to assist you with your project.