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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.

Mass Spectrometric Evaluation of Host Cell Protein Patterns in Biopharmaceutical Products 2019 Poster

Developing and producing recombinant biopharmaceuticals in mammalian cells requires unambiguous monitoring of host cell protein (HCP) impurities. Immunoassays are still the method of choice for release testing, for which it is recommended to demonstrate the suitability of antisera in a QM-regulated environment to meet regulatory demands from FDA or EMA. However, peptide
analysis by MS has been proven to be a valuable tool by providing complementary data for HCP characterization to identify and quantify HCP. In particular, only limited information is published about identities of HCP…

Mass Spectrometric Evaluation of Upstream and Downstream Process Influences on Host Cell Protein Patterns in Biopharmaceu 2019 Poster

For production of mAbs, biopharmaceutical companies often use related upstream and downstream manufacturing processes. Such platforms are characterized regarding influence of USP and DSP parameters on CQAs, which must be monitored strictly by adequate control strategies. One processrelated CQA is the content of HCP, which is typically analyzed by
immunoassays. The capacity of the immunoassay to detect a broad range of HCPs, relevant for the individual mAb-production process should be proven by orthogonal methods. In particular mass spectrometry has become a valuable tool to identify…

Mass spectrometric evaluation of upstream and downstream process influences on host cell protein patterns in biopharmaceutical products Scientific Paper

For production of different monoclonal antibodies (mAbs), biopharmaceutical companies often use related upstream and downstream manufacturing processes. Such platforms are typically characterized regarding influence of upstream and downstream process (DSP) parameters on critical quality attributes (CQAs). CQAs must be monitored strictly by an adequate control strategy. One such process-related CQA is the content of host cell protein (HCP) which is typically analyzed by immunoassay methods (e.g., HCP-ELISA). The capacity of the immunoassay to detect a broad range of HCPs, relevant for the…

Development of a quantitative MS-based multi-attribute method MAM approach for characterization of NBE and Biosimilar Candidates 2019 Poster

In the context of the production and development of biosimilar or new biological agents, it is necessary to analyze multiple samples of different process stages. Thereby differences to corresponding originator products as well as variances between the different samples must be viewed critically. We present an optimization of MAM in IgG1 biosimilar development using Thermo Scientific Q Exactive HF-X instrumentation and the software solution (Protein Metrics Inc.) for fast processing of product quality attributes (PQAs) like post-translational modification levels, terminal variants and…

Complete amino acid sequence verification of biopharmaceuticals using LC-MSMS and Edman sequencing 2019 Poster

The development of recombinant biopharmaceuticals requires intensive investigation of the different levels of structural organization, starting with the primary structure. The confirmationof the amino acid sequence is achieved primarily by mass spectrometry (MS)in combination with liquid chromatography (LC). However, distinction between the isobaric residues leucine(Leu) and isoleucine (Ile) is a major challenge in mass spectrometric peptide sequencing, requiring advanced tandem-MS and ion fragmentation techniques. As an alternative, peptidescontaining these amino acids can be sequenced by…

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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:

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