mAb Development Using Genetic Analysis Solutions

Streamline mAb development with genetic analysis and analytical solutions from discovery through manufacturing

Efficiently develop and characterize recombinant monoclonal antibodies (mAbs) from early discoveries through clinical research and manufacturing by integrating genetic analysis early into your workflows. Utilize reliable analytical approaches to identify and characterize targets, discover scientifically relevant biomarkers, advance clone and cell line development, and detect even trace levels of contamination. Help support the qualty and performance of your products.

 


eBook: Smarter ADCs start with genetic analysis insight

Smarter antibody-drug conjugates (ADCs) begin with better genetic insights. This eBook explores how genetic analysis supports ADC development, from target identification and screening to antibody engineering and payload conjugation, process development, and quality control. Learn how genetic technologies can help optimize mAb design, improve ADC performance, by de-risking the development of  targeted therapies.


Genetic precision for mAb and ADC development interactive infographic

Explore this interactive infographic that brings the complexity of antibody-drug conjugate development into clear focus, starting at early mAb design through process development, quality control, and clinical research. Use genetic precision to help optimize antibody performance, stability, and uncover critical biomarkers. This engaging resource shows how integrated genetic solutions can streamline workflows, help reduce risk, and further progress the path to next-generation therapeutics.


Therapeutic mAb and Antibody Drug Conjugate (ADC) development workflow

Genetic technologies can help accelerate and de-risk mAb and ADC development

 

Use genetic technologies to generate deeper biological insights, inform critical development decisions, and help de-risk your monoclonal antibody (mAb) and antibody-drug conjugate (ADC) programs. Explore each workflow stage to discover where genetic technologies can streamline development and help advance the right candidates, fast.

The research and discovery stage focuses on identifying promising monoclonal antibody (mAb) and antibody-drug conjugate (ADC) candidates, their optimization through engineering, while generating the molecular data needed to confidently advance development.

  1. Discover and verify therapeutic targets
    Identify disease-relevant targets and discover novel antibody candidates using NGS for B-cell repertoire sequencing and gene expression analysis to confirm target biology and biomarker activity.
  2. Engineer and optimize antibody candidates
    Humanize antibodies, improve binding affinity, and optimize ADC linker designs. Sanger sequencing, qPCR, and digital PCR verify genetic modifications, expression levels, and construct integrity.
  3. Characterize antibody function
    Evaluate binding specificity through immune activation, stability, and biological activity using gene expression assays and targeted molecular analysis to confirm therapeutic potential.
  4. Advance candidates into preclinical studies
    Generate quality, pharmacokinetic (PK), pharmacodynamic (PD), and biomarker data while establishing early molecular assays that support future quality control workflows.

Process and analytical development transform promising antibody candidates into reproducible, scalable manufacturing workflows supported by robust analytical methods

  1. Optimize production cell lines
    Select high-producing clones and monitor expression stability using Sanger sequencing, qPCR, and digital PCR.
  2. Develop scalable manufacturing processes
    Refine upstream and downstream processes while using molecular assays to assess clone stability, transgene integrity, and production consistency.
  3. Build analytical methods
    Develop analytical assays to characterize product identity, purity, potency, and critical quality attributes using targeted PCR and sequencing technologies.
  4. Prepare for GMP manufacturing
    Establish reproducible workflows and analytical methods that support technology transfer and cGMP manufacturing readiness.

 Quality control workflows check that every production batch meets analytical regulatory requirements for identity, purity, potency, and contaminant testing

  1. Monitor manufacturing quality 
    Confirm product consistency throughout production using qPCR assays, digital PCR assays, and sequencing-based assays
  2. Detect contaminants
    Identify residual host cell DNA, mycoplasma, adventitious agents, and viral contaminants using qPCR, digital PCR, and NGS.
  3. Verify product identity and purity
    Support batch release with analytical assays that test product identity and detect impurities.

Clinical research uses genetic technologies to identify biomarkers and investigate potential therapeutic outcomes.

  1. Biomarker identification from clinical research samples
    Use gene expression analysis and multiplexing tools to identify biomarkers and correlate them with efficacy.
  2. Longitudinal monitoring
    Measure immune activation and biomarker expression over time using qPCR and dPCR with custom designed assays.
  3. Analitically evaluate and characterize the efficacy of the mAb/ADC molecules
    Define the pharmacodynamic response, circulating tumor DNA (ctDNA) and mutation profiles with qPCR and dPCR.

Ordering information

Quickly order the mAb development bundle of consumables in the table below.

Do you need a qPCR, dPCR or capillary electrophoresis instrument?


Innovative Solutions for Therapeutic Antibody Development

Offering you consistent and innovative solutions for every stage of therapeutic antibody development to help de-risk your development pipeline.

 

Monoclonal antibodies support

Discover our CDMO services for target discovery, process development, clinical trials, and commercial manufacturing of mAbs, biosimilars, bispecific antibodies, and more.

 

Explore our mAb manufacturing solutions

Looking for comprehensive solutions designed to optimize and intensify steps across therapeutic mAb production workflows? Our experienced specialists support informed decision-making to help strengthen performance and advance your program.


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