Newsletter | March 5, 2024

03.05.24 -- Amtagvi Approval: Mass General Cancer Center Weighs In

SPONSOR

INTERPHEX is back in New York with exciting show features. This includes a brand-new conference program! The INTERPHEX Conference will unfold in the Learning Lab on the Exhibit Hall floor of INTERPHEX. It will feature peer-reviewed scientific presentations that examine quality systems, contamination control strategies for cell and gene therapies, 3D bioprinting, AI applications for formulations, and U.S. FDA regulatory updates, among other hot industry topics. Register today.

FROM THE EDITOR

Mass General Cancer Center’s Dr. Genevieve Boland On Amtagvi Approval

The FDA’s approval of Amtagvi addresses an unmet need in melanoma patient care. Here, Genevieve Boland, MD, Ph.D., from Mass General Cancer Center, shares her insight on the approval.

FEATURED EDITORIAL

Regulatory Challenges For Cell-Based Therapies

Dr. Verdun and Dr. Marks provide detailed feedback on the regulatory challenges facing cell therapy and explain the agency’s most important focal points for 2024, patient accessibility, and more.

INDUSTRY INSIGHTS

5 Translational Research Challenges On The Path To Patients

As a translational researcher, you’re paving an uncharted path toward exciting new possibilities in healthcare. Explore five difficulties translational researchers face when developing a new therapy.

Disinfectant Residues: Mitigation And Management

Cleanroom residues can be generated by the disinfectants used on surfaces. Learn about the removal of disinfectant residues and a common method for measuring the potential for residues.

How To Migrate Active CGT Studies To A New EDC

Gain access to the results and lessons learned from a project involving the modernization of an electronic data capture system and mid-study data migrations.

A Multifaceted Strategy For Viral Safety In AAV Processes

Viral safety is essential in the manufacturing of biopharmaceuticals. See why defining and deploying an appropriate and robust viral clearance strategy can be particularly challenging.

Cell Therapy Facility Design; Looking To The Future

Here, the author covers the ongoing demand for more agile and flexible facilities and references the innovative solutions helping the cell and gene therapy space continue to mature and grow.

Closed Systems For Autologous Processes

As autologous cell therapies and other targeted gene therapies work to scale up to commercial levels, connections that can be changed out in seconds represent a distinct advantage for the industry.

Polishing Strategy For Removing Impurities In bsAb Purification

This demonstration showcases a polishing strategy that utilizes a multimodal chromatography media to address the challenges presented by bispecific antibodies (bsAbs) downstream processing.

A Guide To mRNA Vaccine Production And Manufacturing Services

Find out more about the key steps for successful mRNA vaccine production, which encompasses mRNA manufacturing, and ways that you can save valuable time from the start of manufacturing.

SOLUTIONS

The Way Forward In Antibody Therapeutics Purification

Stainless Steel Centrifuges For Regenerative Medicines

Addressing Rapid Biomanufacturing Capacity Needs

Xeno-Free, Serum-Free Media For The Cultivation Of Lymphocytes

Innovative Product Solutions For CAR T Cell Research And Discovery

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