02.25.25 -- Biotechs Should Go With An Uber, Not A Limo

Join Outsourced Pharma Live for an in-depth examination on how the BIOSECURE Act is impacting risk management, compliance, and the future of global outsourcing in drug development and manufacturing. Our supply-chain experts will provide actionable insights to ensure your outsourcing strategies align with the greater legal, regulatory and geopolitical environment. Secure your free registration today!

This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

Ensure a smooth and efficient technology transfer by following key strategies and avoiding common pitfalls to streamline your process and achieve consistent, error-free results.

Reap the benefits of natural history studies, such as the collection of contextual data, dry runs of expected clinical study visits, test deployments, and test endpoint sensitivity.

There is a growing need for innovative solutions that reduce costs while maintaining high product quality. This poster presents investigations to derive an economic and scalable method for purification of AAV.

Experts discuss automation, “platformization,” transitioning early-stage companies to commercialization, and supporting academics driving these innovations.

Explore how patients and health care providers perceive and consider using patient-administered medicines, specifically self-administered injectables and on-body delivery systems.

To prevent path-to-market setbacks, it is critical to develop a CMC strategy that proactively identifies scientific and compliance gaps, as well as mitigates risk.

Witness how TARGATT® gene editing and HLA-F technologies are revolutionizing hypoimmunogenic cell development for scalable allogeneic therapies.

To stay ahead in the competitive landscape of mRNA development, adopt a comprehensive QC strategy today and begin conducting meaningful tests to ensure the quality of your test articles.

Industry experts discuss current and future trends, formulating successful lipid compositions and navigating the constantly evolving genomic medicine landscape.

See how a next-generation rAAV production platform delivers high yields and superior product quality across various serotypes and genome lengths through innovative process optimization.

Consider the effectiveness of a flexible, scalable AAV manufacturing platform that incorporates well-characterized bioreactors and advanced production systems to drive cell and gene development.

Achieving optimized, scalable suspension processes for adeno-associated virus (AAV)-based therapeutics comes with a number of technical and business challenges.

Ran Zhang was hire number one at Landmark Bio back in 2021. Today, she's CEO of the 70+ employee cell and gene therapy manufacturer. The Business of Biotech caught up with her at the JP Morgan Healthcare Conference in San Francisco for a discussion on Landmark's role in addressing the ATMP patient access and cost reduction challenges. Listen now and subscribe so you never miss an episode!

As cell and gene therapies continue to transform modern medicine, Cryoport Systems evolves its products and solutions to meet the needs of the industry and the patients it serves.

Supporting 15+ commercial therapies worldwide, we equip scientists with advanced tools, personalized services, and regulatory support to drive genomic medicine and tackle unmet needs.

Learn how DTP clinical supply enables participants to receive treatments in the convenience and comfort of their own homes while reducing (or eliminating) the need to travel to a clinical site.

With a simple quote and 10 mg of your research grade transgene plasmid, Viralgen can perform a small scale feasibility study, including downstream purification.