Newsletter | February 12, 2024

02.12.24 -- Inside Cell & Gene Live '2024 Regulatory Outlook'


Cell therapies require specialized distribution strategies to safeguard sensitive materials and can be complicated by varying regulations for global shipments. Ensuring the product is delivered on time and within temperature specifications to the hospital is critical and requires meticulous planning across multiple teams. Read the case study and examine how Marken ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy from the U.S. to a manufacturing site in Germany.


Inside Cell & Gene Live ‘2024 Regulatory Outlook’

In case you missed it, our recent Cell & Gene Live, 2024 Regulatory Outlook with FDA’s Dr. Peter Marks and Dr. Nicole Verdun, is available on demand. Here's a summary of the event.


4 Capabilities That Support A Superior Condition Monitoring Solution

CGT's time and temperature sensitivity requires advanced consideration for storage and distribution. Monitoring the location and condition of each shipment is crucial to ensure product safety and quality.

Making The Allogeneic Commercialization Journey

Review the pivotal moments, challenges, triumphs, and lessons learned that have shaped an evolution from facility construction to a fully operational patient-focused CDMO.

Navigating Complex Cell And Gene Therapy Commercial Readiness Hurdles

Gain insights from the first North American CDMO to achieve EMA approval for commercial production of allogeneic cell therapy on approaches for streamlining and accelerating commercialization.

Streamline Process Characterization For Successful Validation Campaigns

Explore how a stepwise approach for process characterization can help target the right experimental design and be tailored for different programs based on prior knowledge and experience.

High-Velocity Development: Gene Therapy Vs. Small Molecule

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.


As the patient’s immune cells are the starting materials, inherent biological variability leads to CAR-T manufacturing. Additional critical raw materials also have batch-to-batch variability, which means the entire production process is a constant balancing act of adjusting the manufacturing process to create standardized manufacturing. Join Cell & Gene Live for a discussion on practical ways to overcome the challenges associated with batch-to-batch variation. Registration is free thanks to the support of Entegris.


Smart Technologies: Scaling iPSC To Benefit Human Health

Gain The Competitive Advantage By Supercharging Supply Chain With AI

Benefits Of Standardizing Viral Vector Processes

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