08.13.24 -- So You Want To Be An Outsourcing-Industry Entrepreneur?

This article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.

While biotechs face pressure to rush to trials, development still requires a significant amount of work. Explore the pitfalls for developers and indicators of GMP readiness.

Purified adeno-associated viruses (AAVs) are prepared as a variety capsid species that must be characterized and quantified to ensure safety and efficacy.

Explore a description of research grade and process development productions of rAAV6, both based on transient transfection of serum-free cells grown in suspension.

CAR T-cell therapies are becoming more precise in targeting cancer cells and overcoming production challenges, and are poised to revolutionize oncology.

mRNA therapy and vaccine manufacturing can become complex and challenging when working with multiple CMOs. Partnering with an end-to-end CMO is key to overcoming the challenges of mRNA manufacturing.

ISO 21973, a vital standard for ensuring safe and reliable transport of CGTs, enhances supply chain efficiency and mitigates risks for the regenerative medicine industry.

Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.

The streamlined AAV transient transfection platform de-risks your path to IND and reduces complexity and timeline for lengthy process and analytical development.

What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships? Join Outsourced Pharma Live on August 13th as our panel of professionals will provide personal analysis and ideas for determining how you might best conduct your development and manufacturing activities, outsourcing business models, and external relationships.

Take a look behind the scenes and hear firsthand about the commitment to patients and clients at Andelyn Biosciences.

Our expanded services and technologies encompass the entire RNA development and manufacturing value chain, helping to deliver your innovation to patients seamlessly.

Explore the benefits of partnering with an experienced CDMO and learn the best practices to ensure seamless plasmid production.

A partner offering a suite of integrated testing services designed to navigate the complexities of cell and gene therapies is critical for accelerating development timelines.