Newsletter | May 8, 2025

05.08.25 -- Upskilling Your Quality Team For The AI Revolution In Pharma 4.0

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Webinar: Mastering the Complexities of Gene Therapy Document Writing

Gene therapy is complex—and so is writing about it. From viral vectors to cell types, every element demands deep understanding. Safety reporting adds further complexity: is an adverse event from chemotherapy, a procedure, or the gene therapy itself? These challenges require a thoughtful, flexible approach to document strategy and execution. Explore common hurdles and practical solutions for gene therapy document writing and submissions.

FOCUS ON MANUFACTURING

Upskilling Your Quality Team For The AI Revolution In Pharma 4.0

While AI systems offer advanced capabilities for data analysis, process optimization, and quality assessments, your quality team must first be proficient in interacting with them.

Forget About Isolators: Switching From Manual Vial To Automated Bag Filling

Discover how transitioning from manual vial filling to single-use bag systems can reduce contamination risk, improve accuracy, and enhance GMP compliance in biopharmaceutical manufacturing.

Computational Fluid Dynamic Characterization Of Vertical-Wheel Bioreactors

Explore how computational fluid dynamics (CFD) characterize and scale-up vertical-wheel bioreactors, optimizing hydrodynamic conditions for effective induced pluripotent stem cell (iPSC) culture.

How To Identify Optimal Materials For Biopharma Single-Use Solutions

Have you thought about how the materials chosen for the tubing, transfer sets, single-use bags, and manifolds in therapy manufacturing could enhance your processes?

How To Successfully Isolate Your T Cells

Explore the results of a study focusing on the early stages of the CAR T cell workflow, specifically the initial washing of leukapheresis followed by the isolation of T cells.

hiPSC Aggregate Expansion In Stirred-Tank Bioreactors

Learn about a bioreactor-based Human Induced Pluripotent Stem Cell (hiPSC) expansion workflow with the potential to improve cell therapy applications.

Using A Closed System For High-Density Cell Culture

Learn how to enhance your projects and support high-density cell cultures using a closed system or closed loop system to minimize contamination and improve safety.

Scalable Production Of Lentivirus For Research To Commercial Manufacturing

Join our webinar on scaling the CTS LV-MAX System in bioreactors, covering transfection scalability, Thermo S.U.B. advantages, and DynaSpin’s efficient gene therapy integration.

Single-Use Centrifuge Boosts Viral Titer Collection From HEK293 Cell Culture

How does the UFMini single-use centrifuge significantly reduce filtration needs and enhance the amount of viral titer collected?

Selecting CGT Manufacturing Processes For Automation

Informing automation decisions involves pinpointing crucial processes for successful batch productions. Prioritize automating processes with the highest risk of human error and the greatest labor cost.

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Discover the future of iPSC-based therapies in this free Cell & Gene Live digital event. Experts will share insights on emerging applications, regulatory challenges, gene editing advancements, and key safety considerations in scalable iPSC manufacturing. Don't miss this opportunity to hear from leaders at the forefront of regenerative medicine. Supported by Invetech.

MANUFACTURING SOLUTIONS

Innovations In Transfection And Electroporation - Lonza

Propelling CGTs From Concept To Commercialization - Roche CustomBiotech

Membrane Selection - Entegris, Inc.

Cleanroom Facility Planning - AES Cleanroom Technology

AAV Manufacturing Workflow Single-Use Solutions - Cytiva

Demo Of At-Line Cell Culture Media Analyzer - Repligen – PAT

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