Newsletter | March 4, 2025

03.04.25 -- CDMOs Bet Big On Asia Expansion. Can Trump Reverse The Tide?

FEATURED EDITORIAL

CDMOs Bet Big On Asia Expansion. Can Trump Reverse The Tide?

Facility investments by CDMOs continue to be magnetized to Asia. Recent examples abound. Chief Editor Louis Garguilo details some of those, and discusses whether, for example, a President Trump-intensified focus on increasing manufacturing in the U.S. can change this. Will your outsourcing in 2025 change direction? The answer may surprise you.

Legend's CARVYKTI Offers Lessons In Commercial-Phase Changes

The company is starting small with a pilot to do what most companies avoid altogether — innovating the manufacturing process for a product already on the market.

INDUSTRY INSIGHTS

Optimizing Cell Therapy Supply Chains For Success

When it comes to transporting highly sensitive and valuable materials, such as cell therapies, learn how teams can ensure that unique storage and distribution requirements are met.

Building A Chromatography Platform For Purification, Full Capsid Enrichment

Developing a robust chromatography platform for AAV8 purification and full capsid enrichment ensures high gene therapy product quality, addressing the challenge of empty capsid removal.

The Sponsor's Clinical Development Handbook For Gene Therapy Trials

Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.

Strategically Design Your Quality Control Toolkit To Better Mitigate Risk

If you’re hoping to improve your QC toolkit to better accommodate complex modalities like cell and gene therapies, it's time to build a program that accounts for risk and unique product characteristics.

Quality Agreements: Defining Governance In CDMO Partnerships

Quality agreements serve a critical role within a CDMO-Sponsor partnership. Review the importance of aligning objectives, quality standards, and compliance frameworks to establish a robust foundation.

Getting Tech Transfer Right First Time

By adopting unified digital platforms, implementing standardized data models, and enabling seamless system integrations, see how established continuous digital threads can enhance connectivity.

Leveraging HTS Tech To Develop Methods For rAAV Characterization

Consider our advanced sequencing protocols and bioinformatics solutions to achieve comprehensive rAAV characterization, ensuring precise analysis of purity, integrity, and identity.

The Key To Accelerating RNA-LNP Drug Development

Here, we examine the benefits of off-the-shelf ionizable lipids and reagent kits that have been pre-developed and pre-optimized for a diverse range of genomic medicine applications.

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.

High-Throughput Screen Finds Targets To Boost AAV9 Production In HEK293 Cells

Take a look at the potential of this small molecule screening to enhance AAV9 production and improve gene therapy manufacturing efficiency by leveraging novel compounds.

Engineered Plasmids, Optimized HEK293 Cell Line Improves AAV Productivity

Low AAV productivity and the absence of platform processes drive up production costs. Discover a scalable suspension manufacturing platform for AAV production.

Achieving Agile, Expert Scale-Up With New Manufacturing Capacity

Finding a manufacturing partner with the capabilities and capacity to offer truly end-to-end development and scale-up can mean the difference between successful commercialization and the end of the road.

SOLUTIONS

Capacity Update July 2024: Cell & Gene Therapy

Kincell Bio is a trusted manufacturing services partner for cell therapy companies, providing expert services including access to CMC development and clinical manufacturing for cell therapy.

Gene Therapy, Oncolytic Viruses, Viral Vaccines CDMO Services

Our gene therapy viral vector process development and manufacturing capabilities are designed to confidently and rapidly progress your products from gene to market through development.

Capacity Update October 2024: Cell & Gene Therapy

Gain insight into our unparalleled expertise as a leading CDMO in viral vectors, offering top-tier process development, analytical development, and manufacturing solutions.

Quality GMP-Grade iPSC And Knockin-Ready TARGATT iPSC

To jump start iPSC derived therapeutic cell product development; achieve reliable and efficient genome integration with our innovative solutions.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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