02.13.24 -- Novo Acquires Catalent, Shakes Up Outsourcing World

The swift progression from gene discovery to mass vaccination in the development of COVID-19 vaccines set a remarkable precedent. This comprehensive exploration aims to shed light on the critical aspects of expediting curative therapies, with a focus on the strategic role that CDMOs can play in this transformative journey. Click here to learn more.

“Having been outsourcing to CDMOs for 20 years in the small molecule space, I see a distinct difference in technical performance compared to my mid-2000s CDMOs," says an executive. What's going on here?

For cell and gene therapy companies, it is critical for commercial, marketing, and digital leaders to understand key business decisions that shape the digital backbone of your commercialization road map.

Developing a client-sponsored target product profile and analytical target profile is critical to move your drug product to clinic efficiently and meet acceptance criteria.

Explore some questions and considerations to help you decide on how to manufacture, either by building capacity and capabilities or partnering with any number of different kinds of CDMOs.

Reliability issues continue to persist in GMP manufacturing for the cell and gene space. Learn how companies are focusing on reliability and predictability to further advance this innovative therapy.

To prepare allogeneic, or "donor-derived," CAR T cells for commercial scale, you must consider scale-up, aseptic processing, single-use systems, facility design, starting material, supply chain, and logistics.

Delve into the intricacies of a successful CDMO relationship and learn how a collaborative approach built on shared goals and open communication can maximize the potential of your cell therapy program.

Review the elements of the complex cGMP tissue sourcing process, prone to misconceptions and pitfalls, to find the “right human tissue” that will yield the desired cell quality and quantity and pass BLA approval.

Unearth why defining meaningful biomarker endpoints has become more nuanced than just figuring out whether the protein of interest is being proliferated or silenced.

No matter where you are with your development journey, our LentiPeak™ platform can help you reach your next milestone faster. Our proprietary lentiviral vector platform offers a serum-free, transient transfection, HEK293-based process.

Experts discuss how cell and gene therapies are changing the healthcare landscape and what needs to be done to bring these advanced therapies to patients.

We are an established leader in advancing vaccines from preclinical development to commercial supply across multiple modalities.