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Custom Gene Synthesis for CAR-T and TCR Constructs for Cambridge-based Cell Therapy Companies

PROVEN INTELLIGENCE ACCELERATING NEXT-GENERATION THERAPIES

Custom Gene Synthesis for CAR-T and TCR Constructs for Cambridge-based Cell Therapy Companies

Plasmid DNA Services for CAR and TCR Construct Development

CELL & GENE | RNA | BIOLOGICS

A stylized, 3D rendering of a DNA double helix in light blue and white, set against a soft-focus, light gray background.

High-Fidelity Genomic Intelligence for Advanced Therapeutics.

Frequently Asked Questions

Q: What is the standard quality control for plasmids encoding CAR or TCR constructs?

Every production undergoes rigorous quality control. This includes full-plasmid Sanger sequencing to verify the complete construct integrity, restriction enzyme digestion analysis to confirm the plasmid map, and spectrophotometry (A260/280) to ensure purity and concentration. All documentation is provided to support your regulatory filings.

Q: How does Franklin Biolabs approach codon optimization for synthetic genes?

Our process utilizes proprietary algorithms to optimize codon usage for maximal protein expression in human T-cells. This involves adjusting the GC content, removing cryptic splice sites, eliminating inhibitory sequences, and ensuring the stability of the resulting mRNA transcript without altering the final amino acid sequence of the CAR or TCR protein.

Q: What plasmid backbones are available for cloning CAR and TCR sequences?

We maintain a library of standard and proprietary lentiviral transfer plasmid backbones suitable for T-cell engineering. We can also accommodate cloning into a client-provided custom vector. Our team consults on promoter selection (e.g., EF-1α, MND) to achieve the desired level of stable, long-term expression in primary T-cells.

Executive Summary

For innovators developing advanced T-cell immunotherapies, the integrity of the initial plasmid DNA is foundational to program success. We provide specialized gene synthesis and plasmid production services focused on Chimeric Antigen Receptor (CAR) and T-Cell Receptor (TCR) constructs. Our approach combines strategic in silico design, including targeted codon optimization for human T-cell expression, with GxP-ready manufacturing and analytics. This ensures the delivery of high-purity, sequence-verified plasmid DNA, providing a robust starting material for lentiviral vector production and subsequent cell line development.

A marketing flyer for Franklin Biolabs detailing their immunogenicity services, including various assays and support for cell and gene therapy clinical trials.

A scientist in a sterile laboratory setting uses a multichannel pipette to transfer pink liquid into a multi-well plate for a high-throughput experiment.

De-Risking Constructs at the Sequence Level

The therapeutic efficacy of an engineered T-cell is directly dependent on the design of its synthetic receptor. Beyond optimizing for antigen affinity, the primary sequence of the construct itself can introduce unforeseen liabilities, particularly immunogenicity. Even minor sequence variations can have significant biological consequences.

For instance, studies have shown that robust cytolytic T-cell responses can be directed against polymorphic peptides in a transgene product, leading to reduced expression and efficacy (PMID: 28137880). This highlights how patient-specific factors, such as HLA type, can interact with subtle variations in a therapeutic protein’s sequence. For CAR and TCR development, this underscores the need for meticulous sequence design to minimize potential immunogenic epitopes from the outset, long before the first vector is produced.

Our DNA services address this challenge at the source. By focusing on the molecular design and verification of the plasmid, we help mitigate risks that could otherwise emerge much later in preclinical or clinical development.

A Manufacturing-Aware Approach to Plasmid Production

Our process is built to support programs targeting an 18- to 24-month timeline to IND. We provide a clear, phase-appropriate path from sequence to high-quality plasmid.

  • In Silico Design & Codon Optimization: We refine your CAR or TCR sequence for optimal expression in human T-cells, removing sequences that could hinder performance or manufacturing.

  • Gene Synthesis & Cloning: Your optimized sequence is synthesized and cloned into a suitable lentiviral backbone, designed for stable expression.

  • Sequence Verification: We perform comprehensive Sanger sequencing to guarantee the final plasmid exactly matches the optimized design, eliminating the risk of off-target mutations.

  • Scalable Production: From research-grade milligram preps to large-scale, multi-gram productions, our process scales to meet your program’s needs.

This entire workflow is supported by our >100,000 sq ft of laboratory and study space, ensuring capacity is available as your program advances.

Our scientific team has contributed to a 100% IND approval success rate for client programs since 2019. While the Franklin Biolabs brand launched in 2024, our legacy of expertise provides the manufacturing and analytical foundation needed to move from discovery to the clinic with confidence.

Technical Visualization: Plasmid DNA Synthesis Workflow

Scientific Process Diagram

This content is for informational purposes. For guidance specific to your therapeutic program, please contact our team for a consultation.

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