Newsletter | March 11, 2025

03.11.25 -- CGT Manufacturing: Distributed & Digital With Deloitte Consulting's Omkar Kawalekar, Ph.D.

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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.

FOCUS ON MANUFACTURING

CGT Manufacturing: Distributed & Digital With Deloitte Consulting's Omkar Kawalekar, Ph.D.

Omkar Kawalekar, Ph.D., Senior Manager, NextGen Therapies Manufacturing & Supply Chain Lead, Deloitte Consulting joins Host Erin Harris to share his expert take on how distributed manufacturing models address capacity constraints and supply chain risks, the role of automation in reducing batch-to-batch variability, as well as the power of digital technologies in optimizing production processes. He also covers the key considerations for CGT companies when choosing between in-house manufacturing and CDMO partnerships, and much more.

PAT: Out Of The Dark Ages

Process Analytical Technology (PAT) is essential for efficient process development, but its implementation requires user-friendly, automated solutions that provide actionable information for scientists.

Addressing The Challenges In Lentivirus Harvest Clarification

Traditional depth filtration struggles with lentiviral harvest clarification, leading to low yields and high costs. However, single-use centrifugation offers a promising alternative.

Process Development Optimization For GMP CAR-T Manufacturing

Explore the significance of process development optimization and key considerations including selecting an outsourcing partner for PD projects, timing, technology, and process transfer, among others.

Advanced Therapy Manufacturers' Checklist For Cleanroom Project Success

Current advances in cell, gene, and tissue therapies require a rethinking of how—and where—cleanroom manufacturing facilities could be built, enabling more options for sponsor process control.

Achieve Higher AAV Productivity With A Next-Gen Transfection Reagent

Learn about a next-generation transfection system that requires 50% less plasmid, decreases transfection reagent consumption, and yields higher AAV productivity to reduce cost per dose.

Disruptive Technologies Transforming Upstream Process Intensification

The demand for complex biologics is driving the need for intensified cell culture technologies. Perfusion using ATF has emerged as a leading solution to increase cell density and productivity.

AAV Titer Estimation With Mass Photometry

How do new mass photometers, featuring a new titer estimation tool, perform as a powerful analysis technique when used to evaluate the quality of AAV samples.

A Revolutionary Workflow For Isolating Cells From Tumor Tissue

Join Dr. Carsten Studte as he delves into the isolation of cells from tumor tissues, including the optimized and automated dissociation of solid tissues.

MANUFACTURING SOLUTIONS

Fetal Bovine Serum (FBS) - Corning Life Sciences

Customized Skid For Large Production Scale: IJM NanoProducer - KNAUER

Customizable Pre-Optimized Cryomedia Formula - Nucleus Biologics

Aseptic Processing Systems For The Filling Of Liquid Pharmaceuticals - AST

Human Mesenchymal Stem/Stromal Cells - RoosterBio

Centrifugal Devices - Cytiva

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