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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…

Development of an MS-based Top-Down High-Throughput Approach for Characterization of NBE and Biosimilar Candidates 2019 Poster

Fast screening and assessment are essential during development of new biological entities
(NBEs) and biosimilar candidates. Top-Down mass spectrometry (TD-MS) analysis with high
mass accuracy quickly provides detailed information on key quality attributes such as
glycosylation, oxidation, deamidation and disulfide linkages.

Development of an MS-based Top-Down High-Throughput Approach for Characterization of New Biological Entities and Biosimilar Candidates Poster

Fast screening and assessment are essential during development of new biological entities (NBEs) and biosimilar candidates. Top-Down mass spectrometry (TD-MS) analysis with high mass accuracy quickly provides detailed information on key quality attributes such as glycosylation, oxidation, deamidation and disulfide linkages.

Accelerated CE Methods for Process Development and Clone Selection as a Medium Throughput Approach 2019 Poster

The development and production of recombinant biopharmaceuticals is a challenging field due to their structural complexity. When implementing a manufacturing process for new biopharmaceuticals or biosimilars, variations in the protein structure or post-translational modifications are likely to occur. Therefore, a characterization program is required. Capillary electrophoresis methods such as cGE (capillary gel electrophoresis) or cIEF (capillary isoelectric focusing) support the characterization of physicochemical properties. While cGE provides information on purity, impurity and size…

Evaluation of aggregation propensity and thermal stability in formulation screening applied to a market-authorized mAb Poster

Formulation development intends to improve the integrity of a therapeutic protein, which is essential for required efficacy, shelf life and safety. During storage, chemical modifications and structural changes may impair the API’s potency and pharmacodynamics. The thermal stability is a suitable indicator for a protein’s long-term stability. Moreover, the formation of aggregates activating undesirable immune responses poses a serious threat to patient safety. Therefore, aggregation propensity and thermal stability are crucial critical quality attributes which need to be addressed in early…

Biopharmaceutical Formulations Analysis 2019 Poster

The integrity of an API is essential for its required efficacy and safety. This integrity depends on the stability, secondary and tertiary structure, aggregation behavior and concentration of the developed molecule. All these factors are highly influenced by the formulation of the API. We support our sponsors in reaching the optimal formulation and address the influence of formulation on critical quality attributes by applying state of the art analysis techniques.

Protagen Protein Services Corporate Brochure Brochure

In working together with its pharmaceutical partners, Protagen Protein Services (PPS) teams generate best-in-class analytical data packages and provide scientific, technical and regulatory support to advance, de-risk and accelerate all stages of biopharmaceutical development including biosimilar development at highest quality from clone through clinic. The analytical reports have been accepted by multiple regulatory authorities worldwide including e.g. FDA (USA), EMA (EU), ANVISA (Brazil) and MFDS (Korea) during all stages of development.

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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

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