">

Viral Vector-Based Gene Therapy Development and Support

Solutions to help you streamline viral vector-based gene therapy asset development from the lab to the clinic.

Consistent quality, trial execution, and production expertise

Gene therapy has emerged as a promising approach to genetic and acquired disease treatment. At the heart of this revolutionary technology is the use of viral vectors, which serve as delivery vehicles for introducing therapeutic genes to target cells. Lean on our team to help you simplify and reduce risk during viral vector-based gene therapy development from discovery through commercialization.

75 gene therapy trials were supported by our clinical research services*

165+ cGMP batches of viral vector-gene therapy products were produced*

4 new gene therapy workflow-enabling products launched*

Insights and resources to support your work

Let the following resources help guide your viral vector-based gene therapy development process. 

Gene therapy: from set-up to scale-up

Whether you’re developing in-house capabilities or outsourcing your projects, let us connect you with scalable solutions to meet your unique specifications.

Considerations for your gene therapy manufacturing strategy

See an overview of viral vector production and purification solutions and the factors that may influence the decision to develop in-house or to seek specialist help.

A Developing, Growing and Changing Regulatory Landscape

Heather Myler, Ph.D., director, PPD Laboratories, bioanalytical lab, discusses regulatory changes in the field.

Benefits of an integrated approach to gene therapy development and manufacturing

Discover the development and commercialization of viral vectors for gene therapy, so you can navigate these hurdles and deliver the project in a timely, cost-effective manner.

Viral vector-based gene therapy development workflow and our solutions

Our team is here to help you streamline gene therapy asset development from the lab to the clinic. Learn more about each workflow step and our selected solutions by opening the sections below.

Once the target is selected and validated, your first key step is to produce and screen for a viral vector that can optimally deliver your gene therapy. Identifying the right vector is an essential part of this workflow.

To optimize therapeutic activity and minimize adverse reactions from empty or partial capsids, it’s important to understand the characteristics and behavior of viral vectors and determine the percentage of full, intact viral capsids.

This step involves the optimization and refinement of cell line development, vector production and characterization. The goal of this workflow is to enhance vector yield, purity and quality while ensuring safety and regulatory compliance with cGMP process.

As you remove impurities, contaminants and host cell components from viral vectors and preserve their integrity and functionality, learn more about our chromatography, filtration and analytical testing solutions.

Conducting comprehensive experiments to evaluate the safety and efficacy, dose optimization, pharmacokinetics and pharmacodynamics of a therapy is part of the preclinical studies process, helping you prepare for important regulatory filings.

To meet the demands of clinical trials, scale your viral vector gene therapy production while ensuring quality and consistency. Doing so will help bring reliability to your process and instill confidence in your product.

Carefully designing and planning clinical trials now will help mitigate risks and build a platform for success. Our team is here to help you navigate both early and late-phase clinical trial planning, execution, and supply chain management.

This workflow step helps ensure that a drug can consistently be produced while meeting quality standards. This is crucial for regulatory submission, providing the necessary data to support the safety, efficacy, and quality of a gene therapy product.

In the presence of rigorous and evolving payer evaluation criteria, price negotiations, and a competitive environment, it’s important to prepare your strategy early in the product life cycle and evaluate it often to help optimize market access.

Help ensure the success of your project for years to come through continuous improvement and adaptability. As you monitor your commercial production process and meet market demands, leverage our services or production scale bioprocessing solutions to optimize your manufacturing costs and extend the value of your therapy.

*All statistics are based on data from 2018 to 2023.

">