Newsletter | April 4, 2024

04.04.24 -- Building A Fit-For-Purpose, Strategic Cell & Gene Production Facility

SPONSOR

Setting the Standard for a Simplified Path to Regulatory Compliance

Adhering to the latest regulatory requirements is critical to simplifying registrations and interactions with authorities. Set the standard in simplified commercialization with testing and validation services, along with expert regulatory support and products and services backed by rigorous quality-assurance processes. Reduce risk with sterile, single-use solutions that maximize closed, aseptic processing. Protect against contamination using serum- and xeno-free cell culture media and reagents. Learn more.

FEATURED EDITORIAL

Building A Fit-For-Purpose, Strategic Cell And Gene Production Facility

By employing flexible and sustainable design strategies and best practices, combined with contingency planning, cell and gene therapy companies can make building their own facilities a reality.

The Biggest Challenges In Autologous Cell Therapy Manufacturing

Listen to tremendous detail around the challenges facing autologous cell therapy manufacturing, from the need for automation in manufacturing to the sourcing of tissue from a specific patient.

INDUSTRY INSIGHTS

Gene Therapy For Mitochondrial Disease: Regulatory Pathways - Part 1

Learn how the FDA's expedited programs, along with the efforts of innovative companies, are paving the way for the development of effective gene therapies to address primary mitochondrial diseases.

Cell Line Development For High-Titer Lentivirus Vector Production

Explore a groundbreaking method to significantly enhance LV vector yield using engineered HEK293T cells. This method sets the stage for enhancing the efficiency and scalability of LV vector production.

Development And Optimization Of Suspension-Adapted 293T Cell Line

Understand how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.

An End-To-End Industrialization Roadmap For Autologous Cell Therapy

Delve into the intricacies and obstacles, utilizing automation to scale operations through the Cocoon® Platform, and establish a vein-to-vein network for achieving precise, timely therapy delivery.

Accelerating Rare Disease Treatments From Concept To Cure

Access a thorough investigation that delves into the critical aspects of expediting curative therapies, with a focus on the strategic role that CDMOs can play in this transformative journey.

SOLUTIONS

Expertly Navigating The Regulatory Landscape Together

Manufacturing GTP And GMP

Connect With Cell & Gene: