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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…

Advanced HDX-MS Approaches for Target Binding Analysis in Biologics Development Brochure

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.

Mass Spectrometry-based Host Cell Protein Analysis in Biologics Development Brochure

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.

Advanced HDX-MS Native-MS Approaches for De-risked Biologic Candidate Selection and CMC Development Whitepaper

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…

Advanced Analytical Approaches for Improved Development of Cell and Gene Therapies Brochure

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 Testing Brochure

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).

Direct Characterization LMW Impurities HILIC-MS 2019 Poster

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…

Extensive sequence verification of biopharmaceuticals using LC-MSMS sequencing 2019 Poster

According to ICH Q6B guideline, in a physicochemical characterization program “The amino acid sequence of the desired product should be determined to the extent possible”. Furthermore, it is noted that “New analytical technology and modifications to existing technology are continuously being developed and should be utilized when appropriate”.

High-Throughput and Comprehensive Characterization of Antibody Drug Conjugates (ADCs) by LC-MS and -MSMS 2019 Poster

Antibody drug conjugates (ADCs) belong to a growing class of highly targeted biopharmaceutical drugs.
They combine a monoclonal antibody that specifically binds tumor surface antigen and a highly potent
cytotoxic drug, which is attached via a chemical linker (1). ADCs, that employ cysteine or lysine residues as
conjugation sites, are highly heterogenous and their characterization presents an analytical challenge (2).
Mass spectrometry is the tool of choice for the routine analysis in the ADC development process.
Here we describe two analytical workflows for…

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Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science regarding characterization, method development, validation and routine testing of antibodies, proteins, vaccines and other formates of biopharmaceuticals. Our sites are equipped with modern, state-of-the-art equipment for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, thermal stability e.g.. We offer service modules for analytcal support from research to approval regarding:

  • Developability
  • Clone Selection & Process Development
  • Extendend Characterization & Comparability
  • Stability & Release