Newsletter | August 25, 2025

08.25.25 -- Clues To Mapping A Crisis-Ready Tech Transfer Playbook

SPONSOR

Webinar: From Diagnosis to Dose in 14 Months: Accelerating Gene Therapy

Discover the inspiring story of how the Krueger family, with the help of Andelyn Biosciences and leading gene therapy experts, developed a treatment for their daughter’s ultra-rare condition in just 14 months—defying timelines. This webinar reveals the power of patient-led advocacy, cutting-edge AAV manufacturing, and bold partnerships, offering a replicable roadmap for rare disease communities seeking faster cures. Click here to learn more.

FOCUS ON OUTSOURCING

Clues To Mapping A Crisis-Ready Tech Transfer Playbook

One of the many people behind AstraZeneca's COVID-19 response describes lessons learned during the biggest global health emergency of the modern era.

Improving Viral Vector Production Through Addressing Complexity

In a recent webinar,  experts explored innovations, addressing production challenges, quality control strategies, and tech transfers to enhance scalability, efficiency, and global accessibility of gene therapies.

Navigating Complex Testing For Viral Vector-Based Gene Therapies

To ensure the success of gene therapy, learn why it is crucial to partner with a CRO that can navigate the challenges of viral vector development and testing.

Expanding Clinical Trials Internationally In The ATMP Space

Discover how the global expansion of ATMP trials offers significant advantages but demands early, strategic planning to overcome complex international challenges.

Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements

Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.

Why Fill/Finish Operations Make Or Break Viral Vector Therapies

Learn how precision fill/finish processes ensure the safety, sterility, and success of cutting-edge viral vector therapies as they move from production to patients.

Outsourcing For Beginners: Cell & Gene Therapy Modalities

Unlock the knowledge and strategies you need to navigate the complexities of CGT outsourcing and accelerate the success of your cell and gene therapy projects.

The Future Of Allogeneic Cell Therapy: Hypoimmunogenic Donor Cells

Explore how TARGATT® gene editing and HLA-F technologies are revolutionizing hypoimmunogenic cell development for scalable allogeneic therapies.

Preparing For FDA Pre-Approval Inspection: Quality And Regulatory Topics

Consider these strategies for meeting quality and regulatory requirements in cell and gene therapies that can also help to identify issues early, reduce risks, and prevent delays and rework.

cGMP-Ready Clonal HEK293 Cell Line For AAV, Lenti-, And Adenoviral Vectors

See how this advanced SKPT-HEK293 4G9 provided a robust solution for efficient viral vector production, supporting a range of AAV serotypes and CAR-T lenti-viral vectors for scalable manufacturing.

Building The Next Therapeutic Modality With End-To-End Product Support

Extracellular vesicles hold immense potential for treating diseases, owing to their natural biocompatibility and ability to carry a diverse arsenal of therapeutic molecules.

OUTSOURCING SOLUTIONS

Double-Stranded mRNA Testing By ELISA - Pace Life Sciences

Preclinical Testing Solutions - Labcorp Cell and Gene Therapy Solutions

An Introduction To Laboratory Services - Andelyn Biosciences

Expediting The Journey From Discovery Through Commercial Release - VintaBio

Robust, Scalable, Suspension Based Platform Redefining LVV Manufacturing - ElevateBio

EVENTS

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines.

 

Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

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