Viral Vector-Based Gene Therapy Development and Support

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.