04.26.24 -- Strategies For Minimizing The Impact Of Bioburden And Sterility Testing On Gene Therapy Batch Yield

By investing in the establishment and maintenance of a high-quality master cell bank (MCB), therapeutic developers can set themselves up for long-term success and ensure supply chain sustainability.

Discover how to integrate appropriate materials and tools for oligonucleotide handling, optimize DNA storage using dedicated fluoropolymer film, perform complex biochemical reactions in bags, and more.

Learn more about the right processes to utilize across the CGT life cycle and why having the right people to develop and execute those processes can ensure success.

Five factors to consider when meeting the challenge of evaluating numerous available products from various manufacturers and selecting reagents that meet your specific experimental needs.

While barrier films in bags can be useful for cold chain applications, they do not fully protect against gas ingress and ignore other sources of permeability.

Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.

Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.

High concentration formulations often present challenges with regard to viscosity as well as potential changes in the behavior upon stability. Discover solutions to mitigate high viscosity.