Newsletter | October 27, 2026

10.27.26 -- The 5 Shifts That Could Remake Lyophilization By 2040

SPONSOR

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

The 5 Shifts That Could Remake Lyophilization By 2040

Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.

When Small Process Changes Become A Different MSC Product

During this final segment of Cell & Gene Live, Miguel Forte, M.D., Ph.D., Kiji Therapeutics, Michael Schuster, Mesoblast, and Edward Ahn, Ph.D., MEDIPOST Inc. cover a particularly strong manufacturing point. Even seemingly minor changes in cell culture, processing, or expansion can accumulate and create product drift, raising the question of when a modified process produces what is effectively a different cell therapy.

Why UV Protection Is Critical For Biopharmaceutical Manufacturing

UV-protective single-use bags address a specific vulnerability in biopharmaceutical manufacturing, where UV exposure during production, storage, and cold chain logistics can compromise sensitive products.

How Advanced Connectors Streamline Cell And Gene Therapy Workflows

Discover insights into how innovative connectors streamline workflows, save time, and enhance reliability in critical applications, ultimately supporting improved outcomes in cell and gene therapies.

Breaking The Bottlenecks In Regenerative Medicine Manufacturing

See how tiered automation platforms resolve cell therapy manufacturing bottlenecks, enabling a seamless transition from clinical trials to high-volume commercial supply.

Automated Fill And Finish For Cell Therapy

Automated fill-finish systems protect sensitive cell therapies using low-shear handling to maintain dose uniformity, cell viability, and process consistency across every batch.

The Hidden Variables In Evaluating Isolator Decontamination Cycle Times

Comparing isolator decontamination cycle times requires evaluating key variables like aeration endpoints and load patterns to build accurate capacity models and avoid costly delays.

Developing Non-PEG Stabilizer Lipids For Nucleic Acid Lipid Nanoparticles

Non-PEG stabilizer lipids may offer a new path for LNP design. Combining strong colloidal performance with greater chemical flexibility helps address growing concerns around PEG-related immunogenicity.

The Importance Of Quality In Raw Material Selection

Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization. 

Breaking The AAV Titer Barrier: A 9x Manufacturing Breakthrough

Targeted optimization of cell culture media and transfection reagents increased AAV titers ninefold while improving full capsid percentages, strengthening HEK293 production, and more.

Residual iPSC And Genomic Stability Testing With High Multiplex Digital PCR

Sensitive digital PCR methods enable confident detection of low‑abundance iPSC markers. Gain insight into how these capabilities support more reliable monitoring and quality assessment.

Successful Upscaling Strategies For Viral Vector Manufacturing

Successful viral vector scale‑up depends on early process design, predictive models, and execution strategies that anticipate GMP realities rather than simply increasing production volume.

In Vivo CAR-T And Gene Editing: Manufacturing Reality Behind The Promise

Gain practical insights into the manufacturing realities shaping in vivo CAR-T development and watch how leading teams are addressing the challenges of scaling both LNP and viral vector platforms.

Efficient Protein Purification Strategies

Examine two rapid, high‑throughput strategies for small‑scale protein separation, using either multimodal resins or ion exchange membranes to achieve efficient, low‑volume purification.

Improving Lentiviral Vector Recovery With Closed Automated Systems

Discover how low-shear centrifugation improves lentiviral vector recovery by replacing traditional depth filtration with closed, automated systems that preserve yield and reduce waste and production costs.

Differentiating CD8+ T Cells From HiPSCs Using Feeder-Free Systems

Learn about a feeder-free method to differentiate CD8+ single positive T cells from human induced pluripotent stem cells, which offers promising advancements for scalable and efficient cell therapies.

How Can I Increase My Viral Titers And Improve The Percentage Of Full AAVs?

Explore various strategies to enhance viral titer and increase the percentage of full AAV capsids, like modifications to transfection reagents, cell lines, media, procedures, and more.

Selecting The Right Single-Use Materials In Biopharmaceutical Manufacturing

Manufacturing operations are getting a boost thanks to single-use technologies, but how do biopharmaceutical manufacturers choose the right materials for constructing their single-use solutions?

SPONSOR

Webinar: Advancing T-Cell Manufacturing: Improving Process Control and Scale-Up with Stirred-Tank Bioreactors

How can stirred-tank bioreactors simplify T-cell manufacturing? Discover how the Gibco™ CTS™ DynaXS™ Single-Use Bioreactor supports activation, lentiviral transduction, and expansion in autologous and allogeneic workflows. Join this Thermo Fisher Scientific webinar to explore performance data, innovative design features, and strategies for improving process control, workflow integration, and scalability in cell therapy manufacturing. Click here to learn more.

MANUFACTURING SOLUTIONS

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Fill/Finish Solutions That Grow With Your Program - IDT Biologika

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Workflow Orchestration Solution For Development - Revvity Signals Software, Inc.

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From Plasmid To Fill/Finish: Your Dedicated RNA Partner - Recipharm Advanced Bio

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Seamlessly Transfer From R&D To Commercial - Eppendorf SE

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Improve Viral Titers In Your AAV Program - Lonza

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Pharmaceutical Modular Cleanroom - AES Cleanroom Technology

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Nanoplasmid Vector Platform - Aldevron

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Advancing The Standard In Clinical Cell Processing - Miltenyi Biotec

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