A5103221355- Viral Infectious Diseases and Gene Expression in Insects
- Protein purification and stability
- Monoclonal and Polyclonal Antibodies Research
- Microbial Metabolic Engineering and Bioproduction
- Advanced Proteomics Techniques and Applications
- CAR-T cell therapy research
- Advanced biosensing and bioanalysis techniques
- Glycosylation and Glycoproteins Research
- RNA and protein synthesis mechanisms
- Advanced Control Systems Optimization
- Virus-based gene therapy research
- thermodynamics and calorimetric analyses
- Spectroscopy and Chemometric Analyses
- Spectroscopy Techniques in Biomedical and Chemical Research
Roche Pharma AG (Germany)
2017-2024
John Wiley & Sons (United States)
2015-2016
Hudson Institute
2016
Bioengineering Center
2015
National Center for Genetic Engineering and Biotechnology
2015
Roche (Switzerland)
2013-2014
CS Diagnostics
2012
Abstract Raman spectroscopy is a very promising tool for monitoring key analytes in mammalian cell culture fermentations real time. However, major challenges are associated with this technology aqueous bioprocessing matrixes such as strong background fluorescence, which typically addressed by computational preprocessing of the raw spectra. In study, we present an extensive combinatorial assessment various machine learning algorithms numerous popular methods on performance and robustness...
Sequence variants in recombinant biopharmaceuticals may have a relevant and unpredictable impact on clinical safety efficacy. Hence, their sensitive analysis is important throughout bioprocess development. The two stage analytical approach presented here provides quick multi clone comparison of candidate production cell lines as first stage, followed by an in-depth including identification quantitation aberrant sequence selected clones second stage. We show that the differential suitable...
Novel biotherapeutic glycoproteins, like recombinant monoclonal antibodies (mAbs) are widely used for the treatment of numerous diseases. The N-glycans attached to constant region an antibody have been demonstrated be crucial biological efficacy. Even minor modifications N-glycan structure can dictate potency IgG effector functions such as antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent (CDC).Here, we present development a glycoengineered CHO-K1 host cell line...
Abstract Engineered mammalian cells are key for biotechnology by enabling broad applications ranging from in vitro model systems to therapeutic biofactories. cell lines exist as a population containing sub-lineages of clones that exhibit substantial genetic and phenotypic heterogeneity. There is still limited understanding the source this inter-clonal heterogeneity well its implications biotechnological applications. Here, we developed genomic barcoding strategy targeted integration...
ABSTRACT In‐depth characterization of high‐producer cell lines and bioprocesses is vital to ensure robust consistent production recombinant therapeutic proteins in high quantity quality for clinical applications. This requires applying appropriate methods during bioprocess development enable meaningful CHO clones processes. Here, we present a novel hybrid approach supporting comprehensive metabolic clone performance. The combines metabolite profiling with multivariate data analysis fluxomics...
In-depth analytical characterization of biotherapeutics originating from different production batches is mandatory to ensure product safety and consistent molecule efficacy. Previously, we have shown unintended incorporation tyrosine (Tyr) leucine/isoleucine (Leu/Ile) at phenylalanine (Phe) positions in a recombinant produced monoclonal antibody (mAb) using an orthogonal MASCOT/SIEVE based approach for mass spectrometry data analysis. The misincorporation could be avoided by sufficient...
Interleukin-2 (IL-2) is a potent molecule in cancer therapy. Clinical application, however, limited due to its strong side effects during the treatment. We developed an IL-2 variant (IL-2v) immunocytokine circumvent drawbacks of current During production IL-2v Chinese hamster ovary (CHO) cells, molecules with fragmented and therefore reduced cytokine activity can be observed. To control product fragmentation different process conditions were investigated. By shifting temperature or pH after...
In mammalian cell culture, especially in pharmaceutical manufacturing and research, biomass metabolic monitoring are mandatory for various culture process steps to develop and, finally, control bioprocesses. As a common measure biomass, the viable density (VCD) or volume (VCV) is widely used. This study highlights, first time, advantages of using VCV instead VCD as depiction combination with an oxygen-uptake- rate (OUR)-based soft sensor real-time estimation single-use bioreactor (SUBs)...
Abstract The use of high‐throughput systems in cell culture process optimization offers various opportunities biopharmaceutical development. Here we describe the potential for acceleration and enhancement product quality de novo bioprocess design regarding monoclonal antibody N‐glycosylation by using an iterative statistical Design Experiments (DoE) strategy based on our automated microtiter plate‐based system suspension culture. In example, combination initial screening trace metal building...
New chemically defined platform media (basal and feed) were developed by leveraging data knowledge from the two Genentech Roche legacy processes, through a series of experiments including high-throughput systems for cell culture, shake flasks, 2L bioreactors pilot-scale bioreactors. An average increase in final titer 30% was achieved compared to platforms. The process resulted product quality attributes (glycans, charge variants, size) that comparable historical data. No new variants...
We present a detailed mass spectrometric analysis of three 2 + 1 T-cell bispecific monoclonal antibodies (TCB mAbs), where an unexpected +15.9950 Da shift in tryptic peptides was observed. This modification attributed to the occurrence 5R-hydroxylysine (Hyl) using hybrid LC–MS/MS molecular characterization and CRISPR/Cas9 gene deletion approach. The found at various sites within TCB mAbs, with conspicuous hot spot motif mirroring prior observation Hyl mapped C H 1–VH Fab domain interface...
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