Specialized Services

Bioneer customizes solutions through-out all phases of early development and across all Bioneer expertise areas some of which are highlighted here.

 

Gene Editing & Reprogramming

We are experts in all aspects of gene editing and in using it to establish customized cell lines, including induced pluripotent stem cells (iPSCs) obtained by reprogramming of somatic cells.

Gene editing

We use gene editing to generate cell lines for in vitro modelling using CRISPR/Cas9 and verified by full QC analysis.

  • Gene Knock-out: precise removal of small parts of genes to create an out-of-frame deletion leading to a premature stop of protein expression.
  • Single base pair mutations: introduction or removal of single bases. Generation of perfect isogenic pairs.
  • Sequence specific deletions: specific removal or introduction of repeat structures or domains in endogenous genes.
  • Reporter cell lines: insertion of reporters (e.g. GFP, RFP, resistance markers) as transcriptional or translational fusions.
  • Controllable exogenous gene expression: insertion of gene-of-interest in expression controllable cassette in safe-site locus, AAVS1

During the last few years, we have built a large collection of isogenic cell lines to study the phenotype of disease-causing mutations. Many of these lines are stored at and available through the European stem cell bank, EBiSC.

Reprogramming (induced Pluripotent Stem Cells (iPSC) Technology)

We also have extensive experience in reprogramming of patient-specific primary cell types (fibroblast, Mesenchymal stem cells, PBMC) into iPS cell lines using non-integrative approaches.

We offer to establish iPSC libraries verified by full QC analysis.

  • Highly efficient reprogramming using episomal-based plasmids
  • Extensive quality control pipeline to ensure high quality iPSC lines
  • Extensive experience in differentiating iPSC/ESC lines into mature cell types of the three germ layers to model different disease phenotypes.

For further information, please contact Department Head Bjørn Holst by phone or email.

Gene editing

We use gene editing to generate cell lines for in vitro modelling using CRISPR/Cas9 and verified by full QC analysis.

  • Gene Knock-out: precise removal of small parts of genes to create an out-of-frame deletion leading to a premature stop of protein expression.
  • Single base pair mutations: introduction or removal of single bases. Generation of perfect isogenic pairs.
  • Sequence specific deletions: specific removal or introduction of repeat structures or domains in endogenous genes.
  • Reporter cell lines: insertion of reporters (e.g. GFP, RFP, resistance markers) as transcriptional or translational fusions.
  • Controllable exogenous gene expression: insertion of gene-of-interest in expression controllable cassette in safe-site locus, AAVS1

During the last few years, we have built a large collection of isogenic cell lines to study the phenotype of disease-causing mutations. Many of these lines are stored at and available through the European stem cell bank, EBiSC.

Reprogramming (induced Pluripotent Stem Cells (iPSC) Technology)

We also have extensive experience in reprogramming of patient-specific primary cell types (fibroblast, Mesenchymal stem cells, PBMC) into iPS cell lines using non-integrative approaches.

We offer to establish iPSC libraries verified by full QC analysis.

  • Highly efficient reprogramming using episomal-based plasmids
  • Extensive quality control pipeline to ensure high quality iPSC lines
  • Extensive experience in differentiating iPSC/ESC lines into mature cell types of the three germ layers to model different disease phenotypes.

For further information, please contact Department Head Bjørn Holst by phone or email.

Molecular Histology and Detection

We offer a broad range of services within molecular histology and detection with a special focus on meeting the demands of the biotech, pharma and ingredients industries related to the pre-clinical biomarker associated drug development and state-of-the-art molecular diagnostics tools.

We assist companies in their biomarker and diagnostic development studies with state-of-the-art molecular histology tools, including immunohistochemistry (IHC) and in situ hybridization (ISH). We develop combined assays that involve IHC and ISH, and perform image analysis. We are specialized in IHC and RNA ISH and in combined assays as specified below:

  • MicroRNA and antisense oligonucleotides (ASO): we now have 2 options for staining microRNA and ASO: Locked Nucleic Acids (LNA) modified probes (Qiagen) and miRNAscope™ probes (Advanced Cell Diagnostics). Our automated LNA probe assays run on our Ventana Discovery Ultra instrument (Roche), and the miRNAscope™ currently is a manual assay.
  • mRNA and lncRNA ISH: for the detection of messenger RNA (mRNA) and long non-coding RNAs (lncRNA), we use RNAscope® detection, which is a technology based on branched-DNA signal amplification. RNAscope assays (Advanced Cell Diagnostics), including duplex assays, convey high specificity and high sensitivity. The automated RNAscope® Assays run on our Ventana Discovery Ultra staining platform.
  • Circular RNA: Advanced Cell Diagnostics’ highly specific BaseScope™ probes are designed for detection of unique splice junctions, such as those in circRNA. BaseScope™ probes can also be designed for detection of mutations. The automated BaseScope™ Assays run on our Ventana Discovery Ultra.
  • Multiplex and combined assays: we develop 2, 3, and 4-plex automated IHC, as well as combined assays that involve IHC and ISH. We offer RNA ISH and combined assays that are multiplex fluorescence detection of RNA and proteins, e.g. detection of mRNA/lncRNAs, and/or microRNA ISH combined with immunohistochemistry.
  • Quantitative image analysis: the combined use of digital whole slides and image analysis provides opportunities to quantify ISH signals from both LNA-based assays and RNAscope-based assays. Image analysis is performed on both bright-field and multiplex-fluorescence digital slides.
  • DNA FISCH/CISH: we also perform chromosomal FISH analyses to determine gene amplifications, chromosomal rearrangements and aberrations.

Bioneer is a Certified Provider of Advanced Cell Diagnostics’ assays, miRNAscope™, RNAscope® and BaseScope™, for detection of microRNA, mRNA, lncRNA and circRNA. Bioneer is a Center of Qiagen Center of Excellence in microRNA ISH-based assays using LNA probes. For further information, please contact Molecular Histology Manager Boye Schnack Nielsen by phone or email.

We assist companies in their biomarker and diagnostic development studies with state-of-the-art molecular histology tools, including immunohistochemistry (IHC) and in situ hybridization (ISH). We develop combined assays that involve IHC and ISH, and perform image analysis. We are specialized in IHC and RNA ISH and in combined assays as specified below:

  • MicroRNA and antisense oligonucleotides (ASO): we now have 2 options for staining microRNA and ASO: Locked Nucleic Acids (LNA) modified probes (Qiagen) and miRNAscope™ probes (Advanced Cell Diagnostics). Our automated LNA probe assays run on our Ventana Discovery Ultra instrument (Roche), and the miRNAscope™ currently is a manual assay.
  • mRNA and lncRNA ISH: for the detection of messenger RNA (mRNA) and long non-coding RNAs (lncRNA), we use RNAscope® detection, which is a technology based on branched-DNA signal amplification. RNAscope assays (Advanced Cell Diagnostics), including duplex assays, convey high specificity and high sensitivity. The automated RNAscope® Assays run on our Ventana Discovery Ultra staining platform.
  • Circular RNA: Advanced Cell Diagnostics’ highly specific BaseScope™ probes are designed for detection of unique splice junctions, such as those in circRNA. BaseScope™ probes can also be designed for detection of mutations. The automated BaseScope™ Assays run on our Ventana Discovery Ultra.
  • Multiplex and combined assays: we develop 2, 3, and 4-plex automated IHC, as well as combined assays that involve IHC and ISH. We offer RNA ISH and combined assays that are multiplex fluorescence detection of RNA and proteins, e.g. detection of mRNA/lncRNAs, and/or microRNA ISH combined with immunohistochemistry.
  • Quantitative image analysis: the combined use of digital whole slides and image analysis provides opportunities to quantify ISH signals from both LNA-based assays and RNAscope-based assays. Image analysis is performed on both bright-field and multiplex-fluorescence digital slides.
  • DNA FISCH/CISH : we also perform chromosomal FISH analyses to determine gene amplifications, chromosomal rearrangements and aberrations.

Bioneer is a Certified Provider of Advanced Cell Diagnostics’ assays, miRNAscope™, RNAscope® and BaseScope™, for detection of microRNA, mRNA, lncRNA and circRNA. Bioneer is a Center of Qiagen Excellence in microRNA ISH-based assays using LNA probes. For further information, please contact Molecular Histology Manager Boye Schnack Nielsen by phone or email.

Drug Formulation & Characterization

We are specialized in oral drug delivery and have a strong track record helping companies turn active compounds into viable drug products.

We offer comprehensive know-how and solutions for analysis, pre-formulation and formulation of small molecules, peptides, and proteins using a broad range of in vitro models and characterization methods.

We simulate the behaviour of drugs and drug products in the gastro-intestinal tract and we assess drug permeability and absorption mechanisms applying physiologically relevant media to simulate desired administration routes:

  • Dynamic Gastric Model (DGM) and duodenal module simulate food effect on drug products
  • Caco-2 cell culture permeability model
  • Mucus secreting cell models
  • Blood Brain Barrier permeability model

Read more about Proteins, Peptides and Small Molecules.

For further information, please contact Department Head Anette Müllertz by phone or email.

We offer comprehensive know-how and solutions for analysis, pre-formulation and formulation of small molecules, peptides, and proteins using a broad range of in vitro models and characterization methods.

We simulate the behaviour of drugs and drug products in the gastro-intestinal tract and we assess drug permeability and absorption mechanisms applying physiologically relevant media to simulate desired administration routes:

  • Dynamic Gastric Model (DGM) and duodenal module simulate food effect on drug products.
  • Caco-2 cell culture permeability model
  • Mucus secreting cell models
  • Blood Brain Barrier permeability model

Read more about Proteins, Peptides and Small Molecules.

For further information, please contact Department Head Anette Müllertz by phone or email.