Newsletter | August 11, 2025

08.11.25 -- Outsourced, In-House, Or A Combo: An Agile Recruiting Strategy Fuels Growth In Pharmas And Biotechs

SPONSOR

Webinar: Unlocking Upstream Value: Donor-to-Dose Solutions for Scalable Cell Therapy Manufacturing

Success in cell and gene therapy starts at the source. In this dynamic webinar, experts from Excellos, Lonza, and Akadeum reveal how early upstream decisions—like donor selection, cell processing, and automation—can make or break your therapy. Discover real-world strategies to boost consistency, cut costs, and scale with confidence—all by rethinking the starting point of CGT manufacturing. Click here to learn more.

FOCUS ON OUTSOURCING

Outsourced, In-House, Or A Combo: An Agile Recruiting Strategy Fuels Growth In Pharmas And Biotechs

There are different staffing options for building an agile and scalable team that can quickly react to shifting needs, resources, and funding.

Ethical, Regulatory Considerations As Gene Editing Technologies Advance

Observe as experts highlight innovative tools and strategies advancing the safety of gene editing therapies while addressing off-target effects, regulatory demands, and manufacturing efficiency.

How To Build Effective Clinical Trial Oversight And Leadership

In a collaborative outsourcing model, the sponsor maintains direct contact with functional leads, eliminating communication gaps and enabling faster, better-informed decision-making.

AAV Viral Titering Using Nanoplate- Based Digital PCR

Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.

From Knowledge Management To Learning Empowerment

Observe how to transform biopharma learning with a human-centered, AI-enhanced ecosystem that personalizes development, fosters engagement, and aligns training with real-world impact.

Accelerate FDA Approval With Fast Track Designation

Learn how Fast Track Designation streamlines the FDA review process and offers faster approval for serious diseases or life-threatening conditions.

Spotlight On Excell-Ence: Project Management Team

Discover the difference a dedicated, expert project management team can make in ensuring the success and smooth execution of your cell therapy programs.

An Extended Kinetics Study Of AAV Viral Vector Production

This study aims to explore the kinetics of capsid formation and impurity profiles over time, offering insights that can inform future process improvements.

Clinical Apheresis: Unlocking Quality For CAR-T And Cell-Based Therapies

Specialized cell collection services depend on access to a large, diverse donor pool as well as robust donor screening and efficient collection practices.

Frequently Asked Questions: New Cloud-Based Monitoring Platform

Monitor assets in real-time, anticipate issues, and maintain optimal performance effortlessly by exploring a cloud-based asset monitoring platform that offers proactive support and rapid response from experts.

A Standardized T Cell Backbone Panel For Immune Monitoring

This validated 22-marker flow cytometry panel enables deep immune profiling to identify key biomarkers influencing ACT efficacy — optimizing cell therapy outcomes and improving patient responses.

The Benefits Of Streamlining And Standardizing Plasmid DNA

The need for greater volumes of high-quality raw materials like plasmid DNA in the cell and gene therapy space has made pDNA standardization integral to streamlining the development process.

Optimized HEK293 Cell Line Improves AAV Productivity

Low AAV productivity and lack of platform processes continue to be key challenges driving AAV production cost up. Explore a robust and scalable suspension manufacturing platform for AAV production.

OUTSOURCING SOLUTIONS

End-To-End Development And Manufacturing Solutions - FUJIFILM Biotechnologies

Sterile Fill/Finish: Capabilities And Capacity - Alcami

Cell Banking: Manufacturing, Testing, Characterization, Release - Minaris Advanced Therapies

Bioanalysis Solutions - SGS

Scalable, cGMP-Ready Process For Viral Vector Manufacturing - Catalent

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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