Newsletter | February 20, 2025

02.20.25 -- January 2025 — CDMO Opportunities And Threats Report

SPONSOR

Applying Next Generation Sequencing (NGS) To Accelerate Cell And Gene Therapy Product Development

Check out this poster which details where Next Generation Sequencing (NGS) can be applied during development and manufacture of cell and gene therapies to accelerate development. Learn how NGS helps you gain greater insights into product characteristics to de-risk the development process from plasmid quality control to cell line characterization to identity confirmation here.

FOCUS ON OUTSOURCING

January 2025 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

3 Questions With CEO Andrew Knudten

Learn about the rapid growth occurring in the gene and cell therapy industry, driven by technological advancements, an increasing number of development programs, and recent product approvals.

How To Adapt Efficiently To A New Era Of Supply Chain Manufacturing

COVID-19 reshaped the pharmaceutical landscape, and its impact on the supply chain is undeniable. As the industry adapts to a new reality, executives are prioritizing reliable, forward-thinking partnerships.

The High Cost Of Going Cheap

Developers often aim to cut expenses during development. Discover the long-term outcomes of cost-effective measures like using RUO leukopaks compared to investing in high-quality GMP-grade vectors.

Tech Transfer: 7 Unique Challenges For Advanced Therapeutics

Ensure the success of your tech transfer by addressing these key challenges and optimizing your processes for seamless scalability and compliance.

Reimagining Viral Vector Production: Scalable Adherent Cell Culture

Intensified adherent cell culture offers a promising solution to the limitations of traditional suspension culture, with the potential to improve efficiency, reduce costs, and accelerate development.

Exploring The Cost Considerations Of Immune Cell Therapies

Immune cell therapies have incredible potential for cancer treatment, and making them more cost effective is a critical consideration for improving patient access and outcomes.

The Future Of Allogeneic Cell Therapy: Hypoimmunogenic Donor Cells

Explore how TARGATT gene editing and HLA-F technologies are revolutionizing hypoimmunogenic cell development for scalable allogeneic therapies.

Support For A Gene Therapy Targeting A Rare Neurodegenerative Disorder

Advance your gene therapy program with expert support for IND submission, including GLP toxicology, biodistribution studies, and tailored CMC services.

New Hope For Neuronal Diseases With PNP-Based Gene Therapy

A new polymer nanoparticle (PNP) system enables targeted delivery of large genetic payloads to neuronal cells, advancing gene therapies for NF1 and other nervous system disorders.

Leveraging Platform Processes For Novel Gene And Cancer Therapeutics

Explore how platform processes advance gene therapies, the impact of strong partnerships on patient access, and the future shaped by these collaborations.

Partnering For Scalable Suspension Processes Tailored To AAV Therapies

Achieving optimized, scalable suspension processes for adeno-associated virus (AAV)-based therapeutics comes with a number of technical and business challenges.

SPONSOR

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.

OUTSOURCING SOLUTIONS

Scalable, cGMP-Ready AAV & LV Platform Processes - IDT Biologika

POSTmark LVV - Landmark Bio

Phase-Appropriate, Tailored Process Development Support - Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises

LEAP Advanced Therapy Platform - BioCentriq

Allogeneic And Autologous Cell Therapy CDMO Services - FUJIFILM Diosynth Biotechnologies

Connect With Cell & Gene: