10.01.24 -- You Want Success With CDMOs? Think In 3s

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.

As most cell therapy products are administered intravenously, they need to comply with requirements for particulate matter. This article shares risk mitigation steps and strategies for testing and release.

Who are QPs? Who trains them? What exactly do they accomplish? Nollaig Buckley has the answers. She’s been an independent QP and consultant for 22 years.

Kirsteen Keith of Immunocore takes a stab at a “killer question” about what drug development sponsors want from the BD side of CDMOs.

Evaluating a potential cell banking partner's experience, testing capabilities, and approach to management can help guarantee the quality and consistency of therapeutic cells.

Take a look at this complex process, prone to misconceptions, to find the “right human tissue” that yields desired cell quality and quantity and passes BLA approval.

Explore the unique challenges and complexities involved in key CGT logistics areas like donor and patient accessibility, critical raw materials management, and innovative temperature control equipment.

AAV has become an increasingly popular vector for gene therapy applications, yet ongoing challenges related to process and analytical development often require significant expertise to navigate.

Help transform the development of advanced therapies by embracing a new standard that delivers quality, speed, and cost-efficiency without compromise.

Here, we evaluate the stability of these variant poly(A) regions and the biological activity of the mRNA containing the variant poly(A) tails made from these templates.

Review the pivotal moments, challenges, triumphs, and lessons learned that have shaped an evolution from facility construction to a fully operational, patient-focused CDMO.

Get all the details on this AAV manufacturing platform designed to achieve short timelines and cost-effective scalability for producing clinical trial and commercial material in bioreactors up to 2000 L.

Join the next Outsourced Pharma Live as our panel explores the critical considerations and best practices for selecting and managing CDMOs in the development of novel therapies, including advanced therapy medicinal products like cell and gene therapies. Industry experts will share insights on evaluating CDMO capabilities, ensuring quality and compliance, and fostering effective partnerships to accelerate innovation while mitigating risks.

In cell and gene therapies, the process is the product. We have deep expertise developing and scaling processes for cell therapies and viral vectors, including lentiviral vectors and AAV.

See how our end-to-end, customer-centric CDMO services that are helping to bring more breakthrough treatments to patients.

Catalent’s UpTempo AAV platform process is a scalable, cGMP-ready process for viral vector manufacturing that can reduce the current 18-20-month development timeline for drug product in half.