05.20.25 -- 'Fractional Hiring' At Your CDMO. Okay With You?

Review the elements of a complex 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.

Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.

 With the increasing number of clinical applications and interest in the field, robust, scalable, and cost-effective platforms for GMP manufacturing of high-quality lentiviral vectors are urgently needed.

New research concludes that potency cannot be decoupled from a product's mechanism of action because surrogate markers fail to capture functional relevance.

To ensure that the transformative potential of cell and gene therapy reaches every patient in need, we must prioritize equitable access and overcome the remaining barriers to widespread delivery.

Discover why this area is poised to become a leading hub for cell and gene therapy, as highlighted by CCS and industry experts at the 6th Annual Supply Chain Summit.

T-cell lymphomas are a complex and increasingly prevalent group of cancers with poor survival outcomes and limited effective treatments, underscoring an urgent need for innovative therapies.

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

The evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.

Our study aims to compare two widely used transfection reagents to our standard process, evaluating their impact on final product quantity and quality as part of our ongoing platform innovation efforts.

Begin your relationship with an experienced AAV manufacturer early in the development journey to ensure that your adeno-associated virus (AAV) therapy reaches patients as soon as possible.

RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.

Accelerate your gene therapy pipeline with our cost-effective, high-quality lentiviral vectors, optimized for clinical and commercial success.

Automate and streamline document control and change control processes, but also all other quality processes, including audit management, training control, CAPA, and nonconformance management.

Partner with us to leverage our global expertise in development and optimization of cGMP scalable processes, the knowledge base of our global network of experts and leading-edge technologies.

Our extensive portfolio includes a wide range of validated, off-the-shelf assays designed to support various research applications, ensuring flexibility and efficiency in your projects.