Newsletter | March 24, 2026

03.24.26 -- Delivery Strategy For Next-Gen Cardiac Gene Therapies

SPONSOR

Building an AAV8 Platform, Together: Lessons From a Collaborative Development Journey

Developing a scalable, GMP-ready AAV8 production platform is complex and requires a unified approach across upstream and downstream operations, data-driven decisions, and efficient progression from bench scale to manufacturing-relevant volumes. In this white paper, Matica Biotechnology and Sartorius demonstrate how collaboration enabled the design, optimization, and scale-up of an integrated AAV8 process to 50L with reproducible performance, sharing practical lessons in upstream optimization, downstream purification, capsid separation, and analytics to support flexible gene therapy manufacturing.

FOCUS ON MANUFACTURING

Delivery Strategy For Next-Gen Cardiac Gene Therapies

As the field matures, the most transformative gene therapies in heart health are treating delivery not as an afterthought but as a fundamental principle.

A New Transfection System Tailored For Optimized AAV Production

In AAV manufacturing, long-term success depends not just on titers, but on maximizing the percentage of full capsids to ensure efficacy, safety, and scalability.

Why Cell Washing Is The Hidden Bottleneck In Gene-Edited Cell Therapy

Scaling up life-saving gene-edited cell therapies means tackling production inefficiencies. Overcoming the time-consuming and risky cell washing step is crucial for clinical and commercial success.

Accelerate Your Path To The Clinic: Custom Cell Culture Media Solutions

A strategic approach to cell culture media is essential for success. Get a head start toward clinical readiness and avoid future hurdles with media optimized for your workflow.

Twist Of Two: 2D-LC For Oligos

Discover how coupling orthogonal mechanisms reveals hidden impurities and creates a more robust strategy for characterizing complex oligonucleotide samples.

Mesenchymal Stromal Cells: The Progress And Manufacturing Challenges

Understand the manufacturing challenges where rapid cell expansion often conflicts with therapeutic secretion profiles, requiring sophisticated quality control and donor selection strategies.

A Quick Start Guide For Efficient Filtration

Learn how to properly install a TFF system with step-by-step guidance on component setup, calibration, and best practices to ensure optimal performance and reliable operation.

Rapid And Sensitive Detection Of Replication-Competent Lentivirus (RCL)

See how a rapid digital PCR workflow enables reliable detection of trace RCL levels while maintaining strong performance in complex samples, which support more confident decisions in manufacturing.

Virus Reduction And Impurity Removal

Examine a DOE-based study that reveals how buffer conditions impact virus and impurity clearance using a mixed-mode resin, as well as gain practical guidance for optimizing downstream purification.

Overcoming Challenges In CGT Development

Explore connector solutions for sterility, chemical compatibility, and ultra-low temperature challenges when setting up a therapeutic process for long-term success.

Delving Into Modular Cleanroom Designs For Drug Manufacturing

Reveal the reasoning behind the increasing demand for cleanroom technology as well as the advantages modular cleanroom design brings to the sterile processing of complex therapies.

SPONSOR

Avoiding Scale-Up Surprises: Applying AI and Rapid Prototyping to Media and Process Development

As biologics grow complex and timelines tighten, early development decisions around media, process, and scalability can create manufacturability challenges. In this webinar, Thermo Fisher Scientific experts explore how AI insights, data modeling, analytical testing, and rapid prototyping help teams evaluate choices earlier, reduce risk and prepare programs for cGMP scale-up and manufacturing readiness. Click here to learn more.

MANUFACTURING SOLUTIONS

Scalable Freezing & Thawing Of Biopharmaceuticals - Single Use Support

Cell Culture Media For Viral Vector Production - Cytiva

Serum, Xeno-Free, And cGMP Cell Culture Media & Supplements - RoosterBio

Manufacturing Solutions For Your Cell And Gene Therapy Journey - Invetech

Complete Organ-Chip Solutions To Fast-Track Your Drug Discovery - Emulate

Connect With Cell & Gene: