Newsletter | June 4, 2024

06.04.24 -- Using Stem Cells As An Immunologic 'Trojan Horse'

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With additional cell therapy approvals on the horizon, a diverse array of products and platforms are needed to ensure safety and efficacy in manufacturing, increase speed to market, and decrease overall COGS. Join Cell & Gene Live for a digital discussion on the next generation of platforms and innovative technologies. Registration is free thanks to the support of Invetech.

INDUSTRY INSIGHTS

FDA’s Advanced Manufacturing Technology Program

Learn about a new Advanced Manufacturing Technologies (AMT) Designation program aimed at accelerating the implementation of technologies that drive speed to patient and enhanced sustainability.

4 Strategies For Modernizing The Manufacturing Quality Control Lab

Business leaders can enhance QC operations by adopting a holistic view of the quality ecosystem and embracing comprehensive modernization strategies. Explore four principles for greater QC lab agility.

Cell And Gene Therapies: A Guide To Single-Use Connections

This article captures learnings about the use of single-use technologies in biopharma manufacturing that can be applied to cell and gene therapies, with a special focus on connection technologies.

Anticipating The Next Decade Of Gene Therapy

Consider what the next decade will bring in terms of alternative gene delivery, upstream and downstream processing, analytical methods, and intensified/continuous processing.

Cell Cube System For Serum-Free Culture Of Vero Cells

Review our work to establish a protocol for culturing Vero cells in serum-free medium on the Corning CellCube System, a compact and scalable method for mass culture of attachment-dependent cells.

Navigating Viral Characterization

Explore how clinicians are tackling challenges in developing AAV vectors for use in gene therapy, working around hurdles to help these vectors meet their full potential to treat rare diseases.

Get Full Control Of Your T Cell Isolation

This study demonstrates the automated magnetic isolation of CD4/CD8+ cells from fresh or frozen leukapheresis using a functionally closed cell processing system paired with a modular application.

8 Ways Medical Device Clinical Trials Differ From Drug Trials

Delve into the nuanced disparities between medical device and drug clinical trials with eight critical differentiators shaping regulatory pathways and patient safety.

Validating Flow Cytometry Assays For Cell And Gene Therapies

Zhaojun Yin, Senior Scientist at Genentech, and Marsilius Mues, R&D Group Leader at Miltenyi Biotec, discuss assay qualification and validation approaches and flow cytometry analytics considerations.

Osmolality Analysis In Bioprocessing: From Theory To Practice

Gain deeper insight into the significant impact of osmolality in bioprocessing and its correlation with immunoglobulin G (IgG) production.

4 Common Types Of Cryogenic Studies For Advanced Therapies

Uncover why cryopreservation studies are so critical and how biopharmaceutical manufacturers can more easily navigate the complexities of this process.

FROM THE EDITOR

Using Stem Cells As An Immunologic 'Trojan Horse'

The immune system makes therapeutic delivery challenging, even for immunotherapies. Learn how Calidi Biotherapeutics is using stem cells to sneak oncolytic viruses past the immune system to solid tumors.

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Webinar: Measuring Viral Vector Purity, Stability and Physical Titer in Minutes –with Just One Tool

Industry expert Dr. Laura Pala will highlight the advantages of macro mass photometry to characterize viral vector purity and stability, and help you understand how the KaritroMP can quickly assess the purity of AdV preparations, quantifying empty capsids and other impurities. Click here to learn more.

SOLUTIONS

Mopping Systems For Critical Environments

Access cGMP Biomanufacturing Capacity Faster

Redefining Drug Discovery And Development

Mobile Cleanrooms For Radiopharmaceutical Manufacturing

Clone, Strain, And Viral Construct Screening Executed For You

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Webinar: Embarking on a Successful Cleanroom Project: Conception to Delivery

Join AES on June 26th! Successful cleanroom projects rely on accurate foresight for regulatory compliance, defining process operations and facility relations. Conceptual design, tailored to client needs, sets the project on course. Our turnkey approach starts at conception, assesses processes, and ensures optimal functionality. Integrated construction uses quality materials for durable, compliant spaces, meeting cGMPs and regulatory expectations. Click here to learn more.

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