06.16.25 -- How Do We Best Meet Future AAV Production Challenges?

Develop lyophilized formulations to overcome stability challenges and significantly extend the shelf life of sensitive therapeutic products.

To ensure the safety of tumor-infiltrating leukocytes (TIL) therapies, it's important to use cGMP-compliant feeder cells confirmed to be non-proliferative through competency testing.

According to the researchers, this plasma-based measurement has the potential to serve as a critical pharmacodynamic biomarker, facilitating the assessment of novel therapeutic approaches.

Ensure the success of your CGT program by strategically planning early, aligning regulatory and clinical pathways, and partnering with experienced experts to navigate development complexities.

Explore how our scalable anion exchange chromatography method can enhance full capsid enrichment and improve the quality of your rAAV manufacturing process.

Explore how SGS's Hudson facility can enhance your drug development process by providing cutting-edge bioanalytical testing solutions and seamless global support.

A panel of experts from across the pharmaceutical/biopharmaceutical industry recently shared their experiences in mitigating financial risk before partnering with a contract research organization (CRO).

Setting up a CGT product for regulatory viability and commercial success means investing to empower process design, plus on-time planning of PPQ and CPV activities.

Stringent QC release testing throughout biologic production, as mandated by health authorities, ensures product safety and quality through evaluations of identity, purity, potency, and critical quality attributes.

This panel session features a decade-long story of partnership in bringing two life-changing gene therapies to market successfully in 2022.