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Why Language Matters in Cell and Gene Therapy

Cell and gene therapy (CGT) represents one of the most innovative and rapidly evolving areas in life sciences. From autologous CAR-T therapies to AAV-based gene delivery platforms, these treatments require precise coordination across complex scientific, regulatory, and manufacturing workflows. As CGT trials expand globally, accurate and compliant translation becomes essential for success.

Clinical protocols, informed consent forms, and regulatory filings must meet the strict language requirements of each local authority while maintaining scientific integrity. Miscommunication in patient-facing materials or technical documentation can delay approvals, compromise safety, or result in noncompliance.

Sesen delivers specialized CGT translation services tailored to the unique demands of this field. Our linguists combine therapeutic area expertise with regulatory knowledge to support high-stakes documents across trial design, CMC, and commercialization. With Sesen, clients gain a trusted partner to help bring breakthrough therapies to patients worldwide—clearly, accurately, and with full regulatory alignment.

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What We Translate in Cell and Gene Therapy

Sesen provides end-to-end translation support across the entire lifecycle of cell and gene therapy development. From early-phase clinical documents to post-approval safety and marketing content, our linguists deliver scientifically accurate, regulatory-ready translations that support global market access and patient safety.

We translate clinical trial documentation required for global CGT study execution, ensuring clarity for investigators and patients.
Includes: Study protocols, investigator brochures (IBs), informed consent forms (ICFs), eligibility questionnaires, patient diaries, and eCOA/ePRO instruments.

Our team supports multilingual submission of regulatory applications to agencies such as the FDA, EMA, PMDA, and NMPA.
Includes: INDs, IMPDs, BLAs, CTAs, fast-track designation requests, orphan drug applications, and agency correspondence.

We handle highly technical Chemistry, Manufacturing, and Controls (CMC) documentation with accuracy and confidentiality, supporting both in-house and outsourced manufacturing workflows.
Includes: Cell bank production protocols, viral vector specifications, transduction procedures, analytical method validations, SOPs, and GMP-compliant batch records.

We localize patient communications for CGT programs across diverse languages and literacy levels, ensuring accessibility and ethical compliance.
Includes: Patient education materials, procedure guides, caregiver instructions, adverse event reporting tools, and multimedia consent content.

We translate high-risk labeling content to meet national and regional requirements for CGT product distribution.
Includes: Primary and secondary container labels, instructions for use (IFUs), preparation and administration guides, and safety-related disclaimers.

Our services extend to the post-approval phase, supporting ongoing compliance, safety monitoring, and patient engagement.
Includes: Risk management plans (RMPs), pharmacovigilance reports, adverse event forms, periodic safety updates, and promotional brochures.

Specialized Expertise Across Cell and Gene Therapy Modalities

Sesen provides expert translation support tailored to the diverse modalities driving innovation in cell and gene therapy. Each platform presents unique scientific and regulatory challenges that require deep subject matter knowledge and precise language localization. Our linguists and regulatory experts specialize in translating high-stakes content across these advanced therapeutic platforms.

We translate documentation related to the development and manufacturing of AAV-based vectors used in in vivo gene therapies. Our services support preclinical studies, vector characterization, and regulatory submissions for therapies targeting rare and inherited diseases.

Key areas: Vector manufacturing SOPs, CMC documentation, biodistribution study reports, and IND submissions.

Sesen supports the localization of clinical and patient-facing materials for both autologous and allogeneic CAR-T programs. We translate complex immunotherapy protocols and instructions to ensure precision and regulatory alignment across study sites and treatment centers.

Key areas: Protocols, infusion instructions, patient consent forms, investigator training manuals, and safety monitoring reports.

We offer high-accuracy translation for genome editing technologies using CRISPR, TALENs, or ZFNs. These therapies demand precise terminology and regulatory clarity, especially during early-phase clinical trials and regulatory review.

Key areas: Gene editing protocols, off-target risk assessments, genome modification reports, and ethics committee documentation.

Our translation expertise extends to mRNA-based therapies and ex vivo cell manipulation platforms, where content spans lab-based procedures, GMP documentation, and global regulatory filings.

Key areas: Nucleic acid formulation methods, cell processing protocols, manufacturing batch records, and clinical trial materials.

Why Choose Sesen for Cell and Gene Therapy Localization

Sesen delivers unmatched specialization in cell and gene therapy translation, combining deep scientific knowledge with regulatory precision. Our tailored approach helps life sciences companies accelerate global development while maintaining the highest standards of quality, compliance, and security.

Unlike general language service providers, Sesen works only with life sciences content. This singular focus enables us to deliver translations aligned with the scientific rigor and regulatory expectations of CGT development.

Our linguists are subject matter experts in gene therapy, cell processing, and regulatory science. Many have advanced degrees in biotechnology or pharmacology and hands-on experience translating INDs, IMPDs, and CMC files.

We support over 150 languages with translation workflows certified under ISO 17100 and ISO 13485:2016, ensuring consistency, accuracy, and traceability across all deliverables.

Sesen leverages secure AI-assisted translation tools to enhance speed and cost efficiency, followed by expert human review to ensure scientific accuracy and contextual appropriateness.

We build and maintain project-specific glossaries and termbases to support consistent use of gene therapy lexicons, technical terms, and regulatory nomenclature across regions and documents.

Our systems and processes are fully compliant with global data protection and regulatory standards, including GDPR, HIPAA, and 21 CFR Part 11, ensuring the confidentiality and integrity of your sensitive data.

Supported Languages

Sesen provides professional translation services for cell and gene therapy documentation in over 150 languages, enabling seamless global clinical trials, regulatory submissions, and commercial launches. We support localization across all major CGT markets with linguists who are native speakers and trained in regulatory and scientific domains.

English, German, French, Japanese, Korean, Chinese (Simplified and Traditional), Spanish, Italian, Portuguese, Dutch, Russian, Polish, Arabic, and Turkish.

Our global language coverage supports market expansion in North America, Europe, Asia-Pacific, Latin America, and the Middle East. Whether you are launching a multi-country trial or preparing a BLA for international approval, Sesen delivers accurate and compliant translations tailored to each region.

Our full language list is available upon request. Contact us to discuss your multilingual needs for upcoming CGT initiatives.

Case Studies: Real-World Success in Cell and Gene Therapy Translation

Sesen supports global biopharmaceutical companies across the full cell and gene therapy pipeline. Our experience spans regulatory submissions, manufacturing documentation, and patient-facing content for high-impact therapies. Below are examples of recent projects that demonstrate our technical expertise, regulatory fluency, and scalable language support.

We partnered with a clinical-stage biotech developing adeno-associated virus (AAV) gene therapies targeting rare neurological disorders. Sesen translated more than 120,000 words of IND documentation into French, German, and Spanish to support simultaneous regulatory submissions to the FDA and EMA. Our deliverables included vector manufacturing protocols, preclinical study summaries, and clinical trial applications, all delivered in compliance with ICH and regional formatting requirements.

Sesen worked with a commercial-stage cell therapy company to localize instructions for use (IFUs) and educational materials for a CAR-T product across 22 languages. Materials included preparation guides, adverse event instructions, and patient-facing content designed for varying literacy levels. All translations were reviewed by in-country medical reviewers to meet regulatory and hospital network standards.

We supported a global CDMO in translating standard operating procedures and batch records for mRNA vaccine manufacturing. The project involved complex formatting in BarTender, including label templates and variable data fields. Sesen delivered language-validated SOPs in Japanese, Korean, and various European languages with precise terminology alignment to meet GMP compliance and inspection readiness.

Frequently Asked Questions

Sesen uses a multi-step process that includes native-language subject matter experts, terminology validation, and in-context QA. Our linguists have backgrounds in molecular biology, pharmacology, or regulatory science and follow ISO 17100-certified workflows to ensure technical precision, scientific clarity, and contextual consistency.

Yes. Our team includes linguists and reviewers with direct experience translating INDs, IMPDs, CTAs, and CMC documentation for cell and gene therapy products. We are well-versed in global regulatory standards including FDA, EMA, PMDA, and NMPA requirements, and apply region-specific terminology for full compliance.

Sesen works with a wide range of file formats used in life sciences, including Microsoft Word, Excel, PowerPoint, PDF, InDesign (IDML), XML, JSON, and BarTender label templates. We also support structured content and platform integration for Veeva Vault, eCTD submissions, and labeling systems.

Yes. We offer expedited services for time-sensitive translation needs. Our operations team can coordinate 24-hour and weekend turnaround for urgent regulatory submissions, safety updates, or board responses without compromising quality or compliance.

Related Services

Sesen provides end-to-end language solutions that support every stage of cell and gene therapy development. Explore our related services designed to ensure consistency, regulatory compliance, and scientific clarity across your entire documentation workflow.

  • Regulatory Translation Services

    Accurate and compliant translations for INDs, BLAs, CTAs, and IMPDs. We support submissions to the FDA, EMA, PMDA, and other global health authorities with certified linguistic and regulatory expertise.

  • CMC Translation Services

    High-precision translation of Chemistry, Manufacturing, and Controls documentation, including SOPs, batch records, and process validation reports. Ideal for GMP-compliant facilities and CDMOs.

  • Labeling and Packaging Translation

    Multilingual translation for IFUs, product labels, cartons, and inserts. We ensure terminology consistency and layout accuracy to meet country-specific labeling regulations.

  • Clinical Trial Translation Services

    Comprehensive support for global trial documentation, including protocols, investigator brochures, informed consent forms, and eCOA/ePRO instruments.

  • eCOA and ePRO Translation Services

    Translation and linguistic validation for electronic clinical outcome assessments and patient-reported outcomes across decentralized and hybrid trial models.

  • Multimedia Localization for Life Sciences

    Voiceover, subtitling, and interactive content localization for CGT patient education, clinical training, and manufacturing instruction videos.

Ready to Translate Your CGT Innovation for Global Markets?

Whether you are preparing for a first-in-human clinical trial, submitting regulatory filings across regions, or launching a commercial gene therapy product, Sesen is here to help. Our team of CGT translation experts is ready to support your global objectives with precision, speed, and regulatory alignment.

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