Newsletter | May 13, 2025

05.13.25 -- Scalable Cell Therapy, Smarter CDMO Selection, And AI's Biopharma Future

SPONSOR

We know how tough it can be to find the right CDMO, especially when capacity is tight and timelines are critical. That's why you’ll find our collection of recent Outsourced Pharma Capacity Update presentations so valuable. Our April Partners Week Update details the latest capabilities and available capacity from 40 leading CDMOs – and you can experience it all from the convenience of your screen. View the on-demand sessions for the modalities that fit your needs.

INDUSTRY INSIGHTS

Enabling Cell Line Tech Transfer For mAb Platform Manufacturing

Technology transfer, the transmission of bioprocess knowledge, skills and technology, is a crucial mechanism for ensuring adequate and timely access to innovative medicines.

Optimizing Cell Therapy Development: Part 2

Plan early and align research, development, and commercial priorities to ensure a seamless transition from clinical development to scalable, cost-efficient commercialization.

Intelligent mRNA Manufacturing Through The Power Of Process Analytical Tech

Learn how predictive models can monitor key CQAs, such as RNA concentration and nucleoside triphosphate consumption, and explore RBP and MIT’s vision for revolutionizing biomanufacturing.

FEATURED EDITORIAL

They Said What? Unexpected Insights Into CDMO Selection

An assortment of conversations with experienced biopharma executives have generated some surprising commentary about CDMO selection. Chief Editor Louis Garguilo puts those insights together in this editorial. They include selection preparation/responsibilities, and some interesting CDMO behaviors of late.

How CAR-NKs Offer Powerful Therapeutic Flexibility

Induced pluripotent stem cells have emerged as a promising platform for producing CAR-engineered NK cells in a standardized, renewable, and scalable way.

INDUSTRY INSIGHTS CONTINUED

Validation Of An LCMS Hybrid Assay With EVOSEP Cleanup

By leveraging this innovative combination, the assay achieves detection limits comparable to traditional methodologies while enhancing overall efficiency and reliability.

Choosing The Right Tech To Optimize Processes, Reduce Costs

Discover how these manufacturing solutions can optimize biopharmaceutical production, ensuring the successful commercialization of therapeutic proteins and broader patient access.

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.

Boosting CMC Regulatory Efficiency In Gene Therapy

Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

Clinical Apheresis: Unlocking Quality For CAR-T And Cell-Based Therapies

Specialized cell collection services depend on access to a large, diverse donor pool as well as robust donor screening and efficient collection practices.

Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges

Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing could solve three of these key challenges regarding instrumentation.

The Future Is Now: How AI Is Reshaping Life Sciences

Artificial Intelligence (AI) is becoming more prevalent today and will play a crucial role in the future. Review the latest AI trends revolutionizing quality management systems in life sciences.

Enabling Commercial AAV Manufacturing By AAV Stable Producer Cell Lines

A high-performance, helper virus-free stable producer cell line is derived from proprietary high-producer HEK293 cells and is cultivated in a chemically defined, serum-free, ADCF medium in suspension.

Reinventing Viral Vector Manufacturing For A Decentralized Gene Therapy Future

Discover how scalable innovation is transforming viral vector production and driving broader, more equitable access to advanced gene therapies.

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Webinar: Optimizing Biotherapeutic Protein Expression with Novel GS® CHO Vector Technology

Recombinant protein production is evolving to meet growing demand. CHO-based systems remain central, but further innovation is needed. Join us on May 19th to learn how Lonza is enhancing its GS® expression vector technology with a high-strength synthetic promoter to boost yields, maintain quality, and support efficient biomanufacturing across diverse therapeutic proteins. Click here to register.

SOLUTIONS

Kona Multiomics Characterization Assay Services

By integrating multi-modal data, we combine gene expression (mRNA levels) with surface protein markers from the same single cells, delivering a powerful and detailed view of cellular biology.

Cell Line Characterization Testing Package

We offer a comprehensive range of assays to ensure the quality and safety of your cell lines. Our expertise in timely characterization is unparalleled, making us the ideal partner for testing.

Navigating The Future: For Each And Every Patient

As a full-service CDMO and bio-logistics provider, we deliver end-to-end solutions across the entire value chain, supporting the production, distribution, and delivery of cutting-edge cell and gene therapies.

Analytics-Driven AAV Development And Manufacturing

Gain a comprehensive understanding of the biochemical composition of each vector batch while minimizing product consumption, ensuring efficiency and precision in analysis.

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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