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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…

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 HCPs 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. 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 little is published about identities of HCP present in marketed biopharmaceutical products.

Advanced Analytical Approaches for Accelerated Development of Gene Therapy Products 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…

Host Cell Protein Analysis in Biologic Drug Development Whitepaper

Host cell proteins (HCPs) are common impurities in biologic drug products and are an
obligatory critical quality attribute (CQA). The individual protein contaminants that make
up the HCP profile, however, may vary significantly among individual biologic products
and expression systems. As such, the HCP profile must be analyzed to identify even low
levels of potentially concerning species in a biologic drug to ensure safety and efficacy.
This whitepaper reviews fundamental aspects of HCPs pertaining to biologic drug
development and current and emerging…

A comparison of UPLC and CE-based approaches for glycan profiling of biotherapeutic proteins 2018 Poster

The characterization of biopharmaceuticals such as new biological entities (NBEs) and their biosimilars is a challenging field due to their structural complexity. When implementing a manufacturing process, variations in the protein structure or post-translational modifications occur. Therefore, a characterization program is required according to the guidelines of national authorities. When characterizing proteins from scratch, glycosylation is a central modification that has to be taken into account, as it can affect the half-life and the stability of the protein.

A Quantitative MS-based Multi-attribute Method (MAM) Approach for New Biological Entities and Biosimilar Candidates Presented by a Full Method Qualification for an IgG1 Market Product 2018 Poster

• Development of an MS-based multi-attribute method (MAM) for monitoring
the product quality attributes (PQA) on a biotherapeutic protein IgG1
market product
• Characterization and quantification of PQAs: amino acid sequence,
terminal processing, truncation, deamidation, oxidation and glycosylation
• Introduction of a concept for full method qualification of a MAM approach
using reversed-phase chromatography in combination with high resolution
mass spectrometry
• Evaluation of the qualification parameters: analyte autosampler…

Host Cell Protein analysis with Mass Spectrometry The power of impurity identification 2018 Poster

Developing and producing recombinant biopharmaceuticals in mammalian cells requires unambiguous monitoring of HCPs 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. However, peptide analysis by MS has been proven to be a powerful tool by providing complementary data for HCP characterization.

Development of a quantitative mass spectrometry-based multi-attribute method (MAM) 2018 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…

In Vivo CQA Mapping/Biotransformation Analysis — Opportunities in De-risking and Advancing Biologic Drug Development Scientific Paper

As a key element of biologic development today, precise characterizations of a drug candidate’s structures, post translational modifications (PTM’s) and determinations of its Critical Quality Attributes (CQA’s) are essential in defining, optimizing and controlling development programs from early candidate design through bioproduction scale-up, CMC package development, clinical trials, BLA submission and post-launch commercialization.

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