Newsletter | June 30, 2026

06.30.26 -- PUPSIT In Cell & Gene Therapy: Risk Reduction Or Operational Complexity?

SPONSOR

Webinar: A Closer Look at How Single Use Consumables Drive Cost per Therapy

Single-use consumables play a critical role in cell and gene therapy manufacturing, influencing cost per therapy, scalability, and operational risk. Join Invetech to explore how early consumable design decisions impact development through commercialization, where consumables add value, and how to identify cost and risk signals sooner. Learn strategies to support efficient scale-up, validation, and long-term manufacturing success. Click here to learn more.

FOCUS ON MANUFACTURING

PUPSIT In Cell & Gene Therapy: Risk Reduction Or Operational Complexity?

Few topics introduced by Annex 1 have generated as much discussion as pre-use post-sterilization integrity testing (PUPSIT). I share key considerations for cell and gene therapies.

Versatile Wrap-Around Labeling For Small Batches And Specialized Vials

Discover a reliable solution for labeling small batches of medical products, including vials, syringes, and cartridges, that fully automatic machines struggle to handle.

Isolator Integration In Cell And Gene Therapy Manufacturing

Safeguard living medicines with a tailored facility design strategy. Evaluate workflows with this six-dimensional model against your CCS for a holistic look to inform your decisions.

Redefining Lentiviral Clarification: A New Path To Higher Yields And Lower Costs

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

Adding Expertise In Specialty Pump Technology

Explore how the integration of specialized diaphragm pumps and precision flow meters provides a robust, data-driven approach to managing critical fluid transfer in global bioprocessing.

xRNA Production: The Economic Case For Continuous Manufacturing

See how a continuous manufacturing platform streamlines production to days, uses real-time quality control, and dramatically cuts costs to accelerate access to new therapies.

Unlocking The Next Wave Of Cancer Vaccines

Understand how advanced ionizable LNP formulations and scalable production strategies accelerate the development and clinical translation of personalized cancer immunotherapies.

Navigating Cell Culture Vessels: A Collection Of Application Notes

Examine scalable strategies for high-yield adherent cell culture. Read how gas-permeable technology optimizes MSC expansion, viral vector production, and extracellular vesicle secretion.

Integrating Smart Building Management And IoT Technologies Into Cleanrooms

IoT-enabled smart BMS modernize biopharmaceutical cleanrooms through continuous monitoring, predictive analytics, energy efficiency, and strengthened regulatory compliance, enabling safer, more efficient operations.

2L Face Ported Bioprocess Bags: Closed, Sterile Cell Harvest, And Separation

Investigate these single-use 2L face ported bags designed for efficient cell harvest and separation, which offer robust film technology, full traceability, and seamless integration.

Enhancing Preclinical Cell Therapy Development

Automation in cell therapy development boosts reproducibility, reduces error, and enhances yield. View how it’s reshaping preclinical workflows and accelerating clinical trial readiness.

Using The Digital Plant Maturity Model And Assessment Tool 3.0

Digital transformation requires a clear framework. Gain insight into how a structured model helps manufacturers assess capabilities, enabling smarter decisions and long-term innovation.

Performance Of A Customizable DMSO-Free Cryopreservation Media Formulation

Cryopreservation enables cell therapy by storing cells long-term. A DMSO-free formula preserves cell viability and health, minimizing toxicities linked with traditional cryoprotectants.

MANUFACTURING SOLUTIONS

Robust Cold Chain Packaging For Every Single-Use Bag - Single Use Support

AAV Gene Therapy: Charting The Course Through Clinical Challenges - MilliporeSigma

A Machine Learning, Auto-Gating Tool For Cell Analysis - BD Biosciences

Scale AAV Production Utilizing The Only Transfection Complex Stabilizer - Mirus Bio

Connect With Cell & Gene: