Cell Line Development

Cell Line Development

With more candidate molecules entering the development pipeline, there is an ever-increasing need to streamline cell line development (CLD) processes to mitigate risks and accelerate early phase testing. As such, adopting the right analytical QC tools for genetic testing is essential to safeguard quality, safety, and efficacy of all manufactured products towards consistent production of biologics.

"Working with the team at Cergentis has allowed us to add an extra dimension to the analysis of our stable cell lines. Their understanding of our needs combined with the reliability and reproducibility of TLA analysis has resulted in a number of successful projects."

Teva Pharmaceuticals
Dr. Teresa Domagala

"Working with Cergentis and utilizing TLA for genotypic characterization of cell lines for biotherapeutic production has been instrumental in understanding our cell line development strategy and processes. Recently, we have used TLA to determine the cause of unanticipated genotype in several targeted-integration clones. Experiments were conducted aimed at determining the integration site(s) to nucleotide resolution, using genome walking followed by TLA. Our collaboration with Cergentis with productive, yielding a publication and attendance at conferences. Overall, the Cergentis customer service is excellent and their technical team is knowledgeable, reliable and supportive. We look forward to future partnership."

Pfizer
Barbara Tevelev - Manager Regulatory CMC Biologics

FIND OUT MORE

Broad applicability of TLA-based solutions in cell line development

Our TLA-based solutions are applicable across several stages of the cell line development process and provide superior genetic cell bank characterization to conventional techniques, such as southern blot, FISH or amplicon sequencing. Our unique expertise has already benefited the likes of Pfizer & Lonza, Janssen R&D and Novartis; find out what it can do for you!

Reporting meets regulatory expectations

Our reporting fulfils FDA and EMA regulatory requirements for pharmaceuticals for human use (ICH guidelines Q5B and Q5D, CTD Quality module, section 3.2.S.2.3). Read more here.

De-risk R&D decisions and minimize time-to-clinic

Our solutions help to eliminate contaminated clones (i.e. those with transgene mutations) early in the cell line development process. In fact, our assays are specifically designed to help you monitor important quality parameters and help you de-risk R&D decisions.

Bispecific antibody production is particularly challenging because it requires the integration of multiple genes and typically involves highly homologous vector sequences. TLA-based solutions can easily discriminate the integration sites of each chain variant, overcoming this major genetic QC challenge.

Streamline GMP manufacturing

Our TLA-based solutions allow you to efficiently streamline your GMP-compliant manufacturing processes and accelerate toward successful commercialization.

PRODUCTS PAGE

Genetic characterization
Mapping exact transgene insertion sites
Characterizing large structural variations at integration sites in the host genome
Complete targeted (trans)gene sequencing
Detections of sequence variants and structural changes within the transgene
Transgene copy number estimation
Assessing the quality and efficiency of gene editing
Confirming on-target genetic alterations
Assess heterogeneity of genome-edited pools of cells
QC large integrated vectors and their insertion sites (e.g. BAC, YAC)
Identity assay for extremely homologous vectors
Vector sequencing
QC of new transfection/transduction gene editing techniques
Clone selection
Master Cell Bank (MCB) Cell bank characterization & clonality assessment
Genetic stability analysis
Cell line development
Monoclonality assurance assay of producer cell lines
  • MCB characterization
  • Breakpoint verification on subclones via qPCR
  • Statistical calculation of MCB clonality probability
  • Unique MCB breakpoint validation via independent control sample analysis
  • Plasmid/vector sequencing
  • Extended reporting for FDA/EMA regulatory filings
Genetic drift assessment
  • Cell line characterization assay
  • Genetic stability comparison of MCB across generations to assess cell line stability
  • Plasmid/vector sequencing
Optimization and QC validation of gene-editing technologies
  • Hotspot identification for high-producing cell lines
  • QC of targeted integrations
  • QC of CRISPR-mediating genome editing
  • Identity assay for highly homologous vectors
Clone selection assay
  • Genomic integration site mapping
  • Characterization of large structural variations at integration sites in the host genome
  • Verification assay of vector backbone integration
  • Copy number estimation
  • Transgene integrity assessment
  • Detection of sequence variants

A robust analytical QC approach that does not compromise on speed or quality

In addition to robustness and quality, we understand that speed is paramount for many of our customers, especially in cell line development. For this reason, we offer two different turnaround time options to ensure you meet your deadlines and minimize time-to-clinic.
 

DOWNLOAD EXAMPLE REPORT   DOWNLOAD CLONALITY REPORT

A single platform providing all relevant genetic characteristics in one experiment

Our proprietary TLA-based assays offer clear advantages over standard approaches, most of which are unable to resolve all essential genetic characteristics in one experiment.
FISH provides low-resolution transgene mapping and offers little information about mutagenesis at the integration site. Southern blot can detect structural variations such as rearrangements, but does not generate sequence information. The hypothesis-driven nature of most PCR-based approaches inhibits the identification of all potential sequence variants in integrated vectors sequences and insertion sites.

See our technological comparison table to see how our TLA-based solutions compare with conventional technologies.

Cergentis: a globally recognized and trusted partner for genetic QC testing

Our TLA-based solutions help our customers:

  • Mitigate risks in R&D program decisions
  • Characterize cell banks (dissect the unique genetic features and make-up of their MCB)
  • Assure monoclonality
  • Assess genetic stability
  • Minimize time-to-clinic by:
    • Streamlining cell line development processes and decreasing turnaround time for clone selection
    • Accelerating cell line development cycle timeline and thus, early phase testing

See what our customers say!

Cergentis has extensive experience analyzing genetic alterations in various forms, establishing itself as the trusted partner for genetic analysis of pharmaceutical (producer) cell lines. 
Since 2012, we have routinely supported and troubleshot important genetic characterization challenges for many leading biotech and pharmaceutical companies across the globe. Our assays have been extensively described in public literature and have enabled notable partnerships, including our collaboration with Novartis
 

Organisms analysed by TLA

  • mosquito
  • fruit fly
  • spider
  • zebrafish
  • mouse
  • rat
  • hamster
  • chicken
  • rabbit
  • goat
  • pig
  • cattle
  • human

Your one-stop shop for genetic testing

Multiple (gene editing) tools
  • Transposon-mediated integrations
    • PiggyBac
    • Sleeping Beauty transposon
  • CRISPR
  • Viral integrations
    • AAV
    • Lentiviral integration events
    • Retroviral
    • HIV.HBV
    • Etc.
  • Random integration events
  • Single or multiple vectors
  • Targeted integrations via homologous recombination
  • Targeted knock-outs
  • Large vector (BAC constructs)
  • Landing pad methods
    • using Fip-FRT/Cre-LoxP
Cell lines
  • CHO (Chinese hamster ovaries)
  • Human cell lines
    • HEK293
    • hiPS
    • ES
    • T-cells
    • Etc.
  • Primary cells

We are a globally recognized and trusted partner for genetic QC testing

Experience how easy our ordering process is.

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