07.21.25 -- The New Clinical Packaging Paradigm: Differentiation And Decentralization

Learn how off-the-shelf, GMP-grade iPSC lines with a Drug Master File (DMF) can accelerate cell therapy development, streamline regulatory approval, and reduce time and cost to clinic.

Discover how a diverse collection of RNA-guided nucleases, base editors, and reverse transcriptase editors with unique PAM recognition sequences can enable flexible and precise genome editing.

Consider how the following strategies can be used to optimize AAV manufacturing by reducing risk and balancing productivity, quality, and cost to meet the growing demands of gene therapy.

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.

For complex projects involving oral solid dosage (OSD) and sterile drug products, selecting the ideal CDMO can play a pivotal role in determining the success of a drug candidate.

By working with a single supplier that can handle the entire manufacturing value chain, companies can reduce risk, improve flexibility, and accelerate their time to market.

Developers often aim to cut expenses during development. Discover the long-term outcomes of cost-effective measures like using RUO leukopaks compared to investing in high-quality GMP-grade vectors.

Ensuring the safety and efficacy of cell and gene therapy treatments necessitates rigorous quality control. See how an outsourcing partner can help you deliver safe, efficacious therapies to patients.

This HEK293-derived, animal component-free suspension cell line forms the foundation of a scalable, robust platform process that accelerates AAV manufacturing.

Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.