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Cell Line Development Genetic QC Solutions
Service
Ensure that your methods are sufficiently robust in the actual production process.
- Determine genomic integration loci following random and/or (semi-) targeted integration
- Robust detection of sequence & structural variants (incl. large chromosomal rearrangements) in & around integrated vector
- Structural variations in the host genome at the integration site(s)
- Vector backbone integration assessment
- Output essential genetic characteristics in a single experiment
- End-to-end genetic QC services
- ISO17025-compliant services*
- Expert scientific consultation
- Genomic coordinates of integration site(s)
- Confirmation of sequence of transgene & flanking regions in GOI
- Expression construct integrity
- Vector copy number estimation
- Actionable (digital) report
- Optional: vector copy number by ddPCR
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Select the clone that harbors the preferred genetic make-up.
- Genetic characterization of each clone
- Identify siblings
- Select clones that contain no undesired mutations
- De-risk clones early in the CLD process
- Facilitate early phase testing & minimize time-to-clinic
- ISO17025-compliant services*
- Expert scientific consultation
- Genomic coordinates of integration site(s)
- Confirmation of sequence of transgene & flanking regions in GOI
- Expression construct integrity
- Vector copy number estimation
- Actionable (digital) report
- Optional: vector copy number by ddPCR
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
In-house
Accelerate time to clinic for CHO clone selection. Benefit from cost-efficiency, scalability & confidentiality. Learn more.
- Reduced CLD turnaround times(7-14 days from sample to results)
- Full in-house control
- Reduced per-sample costs
- Can be fully automated
- Expert training consultation
- Includes wet lab, data analysis training & qualification
- Access to TLApp for data mapping and analysis
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Evaluate the suitability of your MCB for biologics manufacturing to regulatory standards (ICH Q5D).
- ISO17025-compliant services*
- ICH-compliant reporting
- IND-enabling studies
- Scientific consultation
- Reporting that complies with regulatory expectations
- Expert scientific consultation
- Genomic coordinates of integration site(s)
- Confirmation of sequence of transgene & flanking regions in gene(s) of interest
- Expression construct integrity
- Vector copy number by ddPCR
- Actionable (digital) report
- Pre-finalization report review included
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
A rapid and cost-effective approach to analytically assess the probability of monoclonal derivation of your MCB.
- Orthogonal
- ISO17025-compliant services*
- Reporting that complies with regulatory expectations
- Accepted for regulatory filings
- Expert scientific consultation
- Statement of work
- Cell bank characterization
- qPCR-based breakpoint & statistical analysis on 93 subclones (subclone generation is not included)
- Extensive (digital) reporting that meets regulatory requirements
- Pre-finalization report review included
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Monitor whether genetic drift has occurred during production of your biologics or viral vector.
- ISO17025-compliant services*
- Reporting that complies with regulatory expectations
- Expert scientific consultation
- (Digital) reporting meeting regulatory requirements
- Confirmation of sequence of transgene & flanking regions in gene(s) of interest
- Final conclusions on stability of analyzed cell bank(s)
- Vector copy number by ddPCR
- Pre-finalization report review included
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Assays tailored to your needs.
- Customized assays
- Release testing (preclinical lot, phase I)
- ICH-conform reporting
- ISO17025-compliant services*
- Expert scientific consultation
- Tailored to your needs
- Actionable (digital) report
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Performed either in conjunction with TLA-based service or as a stand-alone QC.
- Expert scientific consultation
- Vector copy number by ddPCR
- (Digital) report & interpretation
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Cell & Gene Therapy Genetic QC Solutions
Service
Ensure that your methods are sufficiently robust in the actual production process.
- Robust detection of sequence & structural variants (incl. chromosomal rearrangements) in & around integrated vector
- Outputs all critical (genetic) quality attributes in a single experiment
- Custom-designed genetic assays
- End-to-end proprietary genetic characterization & QC services
- ISO17025-compliant services*
- Expert scientific consultation
- Integration site analysis to evaluate on-target & off-target insertions
- Sequence & integrity of transgene
- Vector integration profile(insertional mutagenesis)
- Vector copy number estimation
- Actionable (digital) report
- Optional: vector copy number by ddPCR
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Genetic monitoring of successive batches of the bulk product, as per FDA recommendation.
- Supporting method & specification development
- Generating analytical testing data that meet regulatory authorities’ guidances & requirements
- ISO17025-compliant services*
- IND-enabling studies
- Expert scientific consultation
- Reporting that complies with regulatory expectations
- Integration site analysis
- Sequence & integrity of transgene
- Vector integration profile (insertional mutagenesis)
- Actionable (digital) report
- Customized report development
- Optional: vector copy number by ddPCR
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Reveal essential genetic characteristics that make up your MCB in a single experiment.
- ICH-compliant reporting
- IND-enabling studies
- ISO-compliant services*
- Expert scientific consultation on development of your bill of testing
- Reporting that complies with regulatory expectations
- End-to-end genetic QC services
- Integration site analysis
- Sequence & integrity of transgene
- Vector integration profile (insertional mutagenesis)
- Genetic modifications (incl. chromosomal rearrangements)
- Vector copy number by ddPCR
- Release specifications development
- Actionable (digital) report
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Comparability assessment between your MCB and LIVCA.
- ISO17025-compliant services*
- Guaranteed turnaround times
- Reporting that complies with regulatory expectations
- Expert scientific consultation
- (Digital) reporting meeting regulatory requirements
- Final conclusions on stability of analyzed cell bank(s)
- Pre-finalization report review included
- Vector copy number by ddPCR
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Assays tailored to your needs.
- Customized assays
- Release testing (preclinical lot, phase I)
- ICH-conform reporting
- ISO17025-compliant services*
- Expert scientific consultation
- Tailored to your needs
- Actionable (digital) report
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Performed either in conjunction with TLA-based service or as a stand-alone QC.
- Expert scientific consultation
- Vector copy number by ddPCR
- (Digital) report & interpretation
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Genetically Engineered (Animal) Model Genetic QC Solutions
Service
Reliably characterize the genetic outcomes of random integrations.
- Robust detection of sequence & structural variants (incl. large chromosomal rearrangements) in & around GOI
- Custom-designed genetic testing
- Generate essential genetic characteristics in a single experiment
- ISO17025-compliant services*
- Expert scientific consultation
- Identify integration site(s)
- Sequence & integrity of transgene
- Vector integration profile (insertional mutagenesis)
- Copy number estimation
- Actionable (digital) report
- Optional: genotyping primer design(cost per set)
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Assess whether the performed genetic modifications have occurred as intended.
- Robust detection of sequence & structural variants (incl. large chromosomal rearrangements) in & around GOI
- Custom-designed genetic testing
- Generate essential genetic characteristics in a single experiment
- ISO17025-compliant services*
- Expert scientific consultation
- Identify integration site(s)
- Sequence & integrity of transgene
- Vector integration profile (insertional mutagenesis)
- Copy number estimation
- Actionable (digital) report
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
QC for potential undesired outcomes resulting from CRISPR-based editing or from a multiplex gene editing strategy.
- Robust detection of sequence & structural variants (incl. large chromosomal rearrangements) in & around GOI
- Custom-designed genetic testing
- Generate essential genetic characteristics in a single experiment
- ISO17025-compliant services*
- Expert scientific consultation
- Identify integration site(s)
- Sequence & integrity of transgene
- Vector integration profile (insertional mutagenesis)
- Copy number estimation
- Actionable (digital) report
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Genetic QC for projects that involve the use of large vectors such as bacterial artifical chromosomes (>50 kb).
- Robust detection of sequence & structural variants (incl. large chromosomal rearrangements) in & around GOI
- Custom-designed genetic testing
- Generate essential genetic characteristics in a single experiment
- ISO17025-compliant services*
- Expert scientific consultation
- Identify integration site(s)
- Sequence & integrity of transgene
- Vector integration profile (insertional mutagenesis)
- Copy number estimation
- Actionable (digital) report
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
Service
Identify all genetic outcomes induced by your gene-editing events.
- Robust detection of sequence & structural variants (incl. large chromosomal rearrangements) in & around GOI
- Custom-designed genetic testing
- Generate essential genetic characteristics in a single experiment
- ISO17025-compliant services*
- Expert scientific consultation
- Identify integration site(s)
- Sequence & integrity of transgene
- Vector integration profile (insertional mutagenesis)
- Copy number estimation
- Actionable (digital) report
*TLA processing of cells, NGS sequencing, and data analysis (excluding copy number and clonality assessments) are ISO/IEC 17025:2017 accredited by the Dutch Accreditation Council RvA, Registration number L671.
