09.17.24 -- BIOSECURE Act Passes House. How Will It Impact Your Outsourcing?

The regulatory submission process is complex and filled with challenges that can jeopardize critical filings. In this session, we’ll explore the key obstacles medical writing submission specialists face today and share proven strategies to ensure successful submissions every time. Click here to learn more.

After four decades in the biopharma industry, including at NIH, Elan Pharmaceuticals, and Gilead Sciences, Nils Olsson may be undertaking his most complex role: continue to develop and supply vital technologies and pathogen-reduced blood components to blood centers, hospitals, and patients relying on safe blood supply. 

These recommendations guide cell and gene therapy companies through the selection process for innovative tools, technology, and services with an eye to enable forward compatibility from early to later stages of development. 

Here is a robust seven-minute discussion among our experienced panelists about the vital role and expectations of project managers both at CDMOs and sponsors.

When it comes to transporting highly sensitive and valuable materials, such as cell therapies, learn how teams can ensure that unique storage and distribution requirements are met.

Quality agreements serve a critical role within a CDMO–Sponsor partnership. Review the importance of aligning objectives, quality standards, and compliance frameworks to establish a robust foundation.

Developing a robust chromatography platform for AAV8 purification and full capsid enrichment ensures high gene therapy product quality, addressing the challenge of empty capsid removal and enhancing therapeutic efficacy.

Achieve your therapeutic and commercial goals by utilizing a tried-and-tested standardized approach combined with the latest technology and reliable analytics.

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

Review how to develop and use QC assays that can facilitate both product and process understanding and control.

Manufacturing viral vectors leaves sponsors vulnerable to high costs, delays, and the possibility of failure. The right CDMO partner can help you reduce timelines and costs.

Review a breakdown of how to requalify every shipper for its impending transit and ensure your therapy material maintains integrity and safety during transportation.

The capacity expansion project at our Thousand Oaks facility will add new cleanrooms, updated development labs, expanded QC labs, and high efficiency warehousing.

Explore how we are enabling therapeutic development of our own and for the entire cell and gene therapy industry.

Easily scale your GMP mRNA projects