Protein-based drugs are characterized with a plentitude of different analytical approaches and methods. Each of these methods provides insight into a certain aspect of the molecule. For example, capillary Gel Electrophoresis (cGE) provides detailed information about the relative impurity content and the purity of an analyte. Especially for low molecular weight species, cGE shows high resolving power and a reproducible relative quantification.

One of the key aspects is not simply just to quantify the different detected signals but also to identify if they originate from the drug…

Host Cell Proteins (HCP) are critical quality attributes and must be monitored during the manufacturing processes by an adequate control strategy.

Protagen Protein Services (PPS) developed an approach for qualitative and quantitative control of HCPs applying shotgun LC-MS. This approach enables us to gain knowledge about HCP level, clusters and species and allows for risk assessment in HCP control.

In this webinar, experts from PPS will discuss the USP and DSP parameters of four different biopharmaceutical products, two different process variants, and one mock…

The development of a biopharmaceutical consists of R&D, CMC manufacturing and clinical trial phases. The quality of the biopharmaceutical product and its assessment via biophysical and biochemical analysis are essential components of this process. The requirements for the protein content determination method are thus very strict, and there is an eminent need for high precision and accuracy. We present a concept for developing, qualifying and validating a precise, accurate and robust method for protein content determination, one that can be adapted to the specific requirements of the product…

Target engagement is a critical factor in drug efficacy. Understanding and controlling how drug candidates interact with their expected targets can be enhanced using combined profiling approaches, specifically high-resolution analyses that provide details about the interaction. Hydrogen-Deuterium Exchange Mass Spectrometry (HDX-MS) and Native Mass Spectrometry (Native MS) are powerful, information-rich approaches that are increasingly used for binding site profiling and analysis of stoichiometry.

Host cell proteins (HCPs) are impurities present in all therapeutics derived from biological sources, and as a critical quality attribute (CQA), they must be characterized in detail and controlled through the manufacturing process and in the final drug product.

Despite substantial efforts utilizing a diverse set of biologic evaluation and highthroughput techniques to select candidates with the best chance of success in preclinical development, the vast majority of biologic drug molecules fail in clinical trials. With most biologic drugs, including gene therapies, failures are realized in late-stage development, after substantial investment has been made in a candidate. Here, we discuss the potential for improving identification of potentially successful biologic drugs and de-risking CMC and clinical designs earlier through strategic application of…

Cell and gene therapies have the potential to provide long-term therapeutic efficacy, but their development is both risky and cost-intensive. Obtaining a better understanding of the specific structural attributes of vector proteins that influence clinical delivery and outcomes is essential for advancing both individual candidates and the platforms on which they are based.

Stability programs are mostly conducted over several years. It is vital that all analytical techniques perform in a robust manner, in order to prevent out-of-specification (OOS), out-of-expectation (OOE), or out-of-trend results (OOT), which would put the study or a potential product release at risk. PPS qualifies and validates all applied methods, including a profound robustness assessment for critical methods (e.g. by DoE approaches).

The characterization of modern biopharmaceuticals is challenging, as the proteins show a large heterogeneity not only regarding modifications, but also in charge, conformation and microheterogeneity. Changes within this composition can have a large impact on efficacy and safety. In particular for the prove of biosimilarity the knowledge about quality attributes is crucial. Current methods are able to monitor single attributes of the complex composition (HPLC, CE, CGE, CZE). Combination of methods like SEC-MS, IEX-MS promise to monitor multiple critical quality attributes at one time and might…