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.

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…

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.

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.

The development and production of recombinant biopharmaceuticals and their biosimilars
is a challenging field due to their structural complexity. While demonstrating batch to batch
comparability is a demanding analytical task, demonstrating biosimilarity is even more
challenging as it is already performed during early development with limited knowledge of
the structural features of the biosimilar candidate and limited molecule specific method
experience. Additionally analytical methods in biosimilar development need to be applied
for different aspects…

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.

A thorough understanding of drug metabolism and disposition can aid in the assessment of efficacy and safety.
However, analytical methods used in pharmacokinetics (PK) studies of protein therapeutics are usually based on
ELISA, and therefore can provide a limited perspective on the quality of the drug in concentration
measurements. Individual post-translational modifications (PTMs) of protein therapeutics are rarely considered
for PK analysis, partly because it is technically difficult to recover and quantify individual protein variants from
biological…

Characterization of biopharmaceutical proteins and assessment and understanding of the critical
quality attributes (CQAs) is a significant part of biopharmaceutical product development and is routinely
performed in vitro. In contrast, systematic analysis of the quality attributes in vivo is not as widespread,
although metabolism and clearance of multiple variants of therapeutic proteins administered to nonhuman
primates and human subjects may have a different impact on safety, efficacy and exposure. The
major hurdles of such studies are usually sample…

The development of biosimilars is a challenging field due to the need of achieving highest similarity to a structural highly complex molecule. The establishment and development of a high
productive and robust production process represents a challenging and critical path prior to the biosimilar comparability demonstration. When implementing a process for the synthesis of
new biological entities (NBE) or biosimilars, variations in the protein structure or post-translational modifications can occur. A subset of qualified and robust analytical methods are
required to monitor…

The development and production of recombinant biopharmaceuticals and their biosimilars
is a challenging field due to their structural complexity. While demonstrating batch to batch
comparability is a demanding analytical task, demonstrating biosimilarity is even more
challenging as it is already performed during early development with limited knowledge of
the structural features of the biosimilar candidate and limited molecule specific method
experience. Additionally analytical methods in biosimilar development need to be applied
for different aspects…