Newsletter | March 4, 2025

03.04.25 -- New AAV Reference Standards To Aid CQA Assessment

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Webinar: Expanding the Horizons of Cellular Therapy: Clinical-grade Manufacturing of Difficult-To-Transduce Cells

Lentiviral vectors (LVV) are key for cell engineering, but VSV-G pseudotyping has limitations in some cells. BaEV-env pseudotyped LVVs improve efficiency in hard-to-transduce cells like NK and T cells. This webinar covers Miltenyi's preclinical evaluation of BaEV-LVV engineered CAR-NK cells and their development of a clinical-grade manufacturing platform for therapeutic use. Click here to learn more.

FOCUS ON MANUFACTURING

New AAV Reference Standards To Aid CQA Assessment

AAVs' complexity makes them difficult analytical testing subjects. The second part of a series describes USP's latest effort to help characterize the viral vectors.

A Practical Packaging Components Checklist For Emerging Biotechs

A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

How AI Is Streamlining Cell And Gene Therapy Manufacturing

Learn how AI, powered by quality data and real-time monitoring, is accelerating production and bringing life-saving treatments to more patients.

Optimized Production Of Recombinant Proteins

Advancements in recombinant protein production have improved efficiency and quality. However, optimizing cell culture media remains crucial to ensure maximized yield and desirable product attributes.

Maximizing CAR-T Cell Yields With Perfusion And Stirred-Tank Bioreactors

Join UCL experts in exploring how advanced perfusion techniques and stirred-tank bioreactors can enhance CAR-T cell manufacturing with improved yields, scale-up, and reduced costs.

Predicting Antibody-Dependent Cell-Mediated Cytotoxicity

We developed and validated a dual screening procedure (genotype and phenotype) for Lonza human peripheral blood mononuclear cells (PBMCs) to identify donors with high ADCC potential.

Maintain Sterility And Ease In CGT Development, Including Cryopreservation

Sterile connectors streamline cell and gene therapy processes while maintaining sterility. By withstanding extreme temperatures and cryoprotectants, they can ensure product viability during cryopreservation.

CAR T Set The Pace So All Can Win The Cell Therapy Race

Gain insight into the modest origins of cell therapy manufacturing and how this history has paved the way for future advancements from Bill Shingleton, R&D Leader at Cytiva.

Use Of 60 Micron Plastic (PE) Retention Filter For Perfusion Media Exchange

Explore guidance on the materials and methods recommended for assembling a perfusion system using a 60 Micron Plastic (PE) Retention Filter with a Vertical-Wheel Bioreactor.

Applying High Throughput Processes To Optimize AAV Titers

A growing number of AAV product developers are recognizing the value in moving to suspension as early in development as possible in order to optimize production.

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Webinar: Embracing Today, Shaping Tomorrow: Driving Innovation in Decentralized Manufacturing

With over 75% of U.S. hospitals facing medication shortages, decentralized manufacturing offers a vital solution by bringing drug production closer to patients. This webinar explores how Germfree and On Demand Pharmaceuticals’ collaboration enables on-site, agile medicine production. Learn how localized manufacturing enhances supply reliability, regulatory compliance, and patient access through cutting-edge cleanroom and compounding technologies. Click here to learn more.

MANUFACTURING SOLUTIONS

Korus Counterflow Centrifugation System - Invetech

TransIT-AAViator Transfection System - Mirus Bio

A Cell Therapy Manufacturing Platform For Increased Productivity - Cytiva

Powering Excellence In Development & Manufacturing - Roche CustomBiotech

Freezing Studies: Data-Backed Decisions For Cryopreservation Solutions - Charter Medical

Pharmaceutical Cleanroom Pre-Engineering And Pre-Construction Services - AES Clean Technology, Inc.

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Join Cell & Gene Live for an exclusive look at cutting-edge manufacturing technologies revolutionizing cell therapy production. Our expert panel will explore organoids, 3D cultures, automation, and scalable solutions to streamline processes and enhance efficiency. Gain insights into the latest innovations driving the future of cell therapy. Registration is free thanks to the support of CPC and MaxCyte.

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