Products & Services

CHOOSE YOUR SOLUTION

 

Cell Line Development Genetic QC Solutions

OPTIMIZATION & VALIDATION OF (NEW) EDITING METHODS
Service

Ensure that your methods are sufficiently robust in the actual production process.
 

Benefits
  • 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
     
Deliverables
  • 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
     
Quality standards

*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.


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CLONE SELECTION
Service

Select the clone that harbors the preferred genetic make-up.
 

Benefits
  • 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
     
Deliverables
  • 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
     
Quality standards

*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.


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CHOice®
In-house

Accelerate time to clinic for CHO clone selection. Benefit from cost-efficiency, scalability & confidentiality. Learn more.

Benefits
  • 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
     
Deliverables
  • Includes wet lab, data analysis training & qualification
  • Access to TLApp for data mapping and analysis
     
Quality standards

*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.


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FULL (MASTER) CELL BANK CHARACTERIZATION
Service

Evaluate the suitability of your MCB for biologics manufacturing to regulatory standards (ICH Q5D).

Benefits
  • ISO17025-compliant services*
  • ICH-compliant reporting
  • IND-enabling studies
  • Scientific consultation
  • Reporting that complies with regulatory expectations
  • Expert scientific consultation
     
Deliverables
  • 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
     
Quality standards

*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.


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CLONALITY ASSURANCE PACKAGE
Service

A rapid and cost-effective approach to analytically assess the probability of monoclonal derivation of your MCB.

Benefits
  • Orthogonal
  • ISO17025-compliant services*
  • Reporting that complies with regulatory expectations
  • Accepted for regulatory filings
  • Expert scientific consultation
     
Deliverables
  • 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
     
Quality standards

*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.


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GENETIC STABILITY PACKAGE
Service

Monitor whether genetic drift has occurred during production of your biologics or viral vector.

Benefits
  • ISO17025-compliant services*
  • Reporting that complies with regulatory expectations
  • Expert scientific consultation
     
Deliverables
  • (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
     
Quality standards

*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.


 


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CUSTOMIZED VALIDATED ASSAYS
Service

Assays tailored to your needs.
 

Benefits
  • Customized assays
  • Release testing (preclinical lot, phase I)
  • ICH-conform reporting
  • ISO17025-compliant services*
  • Expert scientific consultation
     
Deliverables
  • Tailored to your needs
  • Actionable (digital) report
     
Quality standards

*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.


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VECTOR COPY NUMBER DETERMINATION BY DDPCR
Service

Performed either in conjunction with TLA-based service or as a stand-alone QC.

Benefits
  • Expert scientific consultation
     
Deliverables
  • Vector copy number by ddPCR
  • (Digital) report & interpretation
     
Quality standards

*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.


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Cell & Gene Therapy Genetic QC Solutions

OPTIMIZATION & VALIDATION OF (NEW) EDITING METHODS
Service


Ensure that your methods are sufficiently robust in the actual production process.
 

Benefits
  • 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
     
Deliverables
  • 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
     
Quality standards

*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.


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PROCESS DEVELOPMENT & VALIDATION
Service


Genetic monitoring of successive batches of the bulk product, as per FDA recommendation.

Benefits
  • 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
     
Deliverables
  • Integration site analysis
  • Sequence & integrity of transgene
  • Vector integration profile (insertional mutagenesis)
  • Actionable (digital) report
  • Customized report development
  • Optional: vector copy number by ddPCR
     
Quality standards

*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.


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MCB CHARACTERIZATION FOR EX VIVO GENE & CELL THERAPY APPLICATIONS
Service


Reveal essential genetic characteristics that make up your MCB in a single experiment.
 

Benefits
  • 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
     
Deliverables
  • 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
     
Quality standards

*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.


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GENETIC STABILITY PACKAGE
Service

Comparability assessment between your MCB and LIVCA.

Benefits
  • ISO17025-compliant services*
  • Guaranteed turnaround times
  • Reporting that complies with regulatory expectations
  • Expert scientific consultation
     
Deliverables
  • (Digital) reporting meeting regulatory requirements
  • Final conclusions on stability of analyzed cell bank(s)
  • Pre-finalization report review included
  • Vector copy number by ddPCR
     
Quality standards

*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.
 


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CUSTOMIZED VALIDATED ASSAYS
Service

Assays tailored to your needs.
 

Benefits
  • Customized assays
  • Release testing (preclinical lot, phase I)
  • ICH-conform reporting
  • ISO17025-compliant services*
  • Expert scientific consultation
     
Deliverables
  • Tailored to your needs
  • Actionable (digital) report
     
Quality standards

*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.  
 


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VECTOR COPY NUMBER DETERMINATION BY DDPCR
Service

Performed either in conjunction with TLA-based service or as a stand-alone QC.

Benefits
  • Expert scientific consultation
     
Deliverables
  • Vector copy number by ddPCR
  • (Digital) report & interpretation
     
Quality standards

*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.


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Genetically Engineered (Animal) Model Genetic QC Solutions

TRANSGENE MAPPING ANALYSIS
Service

Reliably characterize the genetic outcomes of random integrations.

Benefits
  • 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
     
Deliverables
  • 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)
     
Quality standards

*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.


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TARGETED INTEGRATIONS QC
Service

Assess whether the performed genetic modifications have occurred as intended.

Benefits
  • 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
     
Deliverables
  • Identify integration site(s)
  • Sequence & integrity of transgene
  • Vector integration profile (insertional mutagenesis)
  • Copy number estimation
  • Actionable (digital) report
     
Quality standards

*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.


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CRISPR GENE EDITING QC
Service

QC for potential undesired outcomes resulting from CRISPR-based editing or from a multiplex gene editing strategy.

Benefits
  • 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
     
Deliverables
  • Identify integration site(s)
  • Sequence & integrity of transgene
  • Vector integration profile (insertional mutagenesis)
  • Copy number estimation
  • Actionable (digital) report
     
Quality standards

*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.


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LARGE VECTOR (E.G. BAC) INTEGRATION SITE MAPPING
Service

Genetic QC for projects that involve the use of large vectors such as bacterial artifical chromosomes (>50 kb).

Benefits
  • 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
     
Deliverables
  • Identify integration site(s)
  • Sequence & integrity of transgene
  • Vector integration profile (insertional mutagenesis)
  • Copy number estimation
  • Actionable (digital) report
     
Quality standards

*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.


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GENETICALLY ENGINEERED CELL LINES QC
Service

Identify all genetic outcomes induced by your gene-editing events.
 

Benefits
  • 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
     
Deliverables
  • Identify integration site(s)
  • Sequence & integrity of transgene
  • Vector integration profile (insertional mutagenesis)
  • Copy number estimation
  • Actionable (digital) report
     
Quality standards

*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.


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