Newsletter | May 6, 2025

05.06.25 -- Cutting Costs In Cell & Gene Therapy? Read This First.

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

Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends

Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

The Hidden Costs Of Cutting Corners

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.

Developing Scalable, Global Solutions For Cell & Gene Manufacturing

Cell and gene therapies offer transformative potential for treating complex diseases, but their manufacturing and global delivery face significant challenges.

FEATURED EDITORIAL

Tariffs Won't Stop Drug-Candidate Licensing From China Biotechs

According to Global Data, the total deal value of U.S. licensing of innovator drug candidates from Chinese biopharma companies has surged since 2020. This is an area way upstream of the current tariff focus on manufacturing. But how this R&D trend and those tariffs play out will  impact your U.S.-based CDMOs.

Ramping Up GMP-Compliant CAR-NK Manufacturing At Scale With iPSCs

The ability to produce billions of NK cells in a single production run represents a transformative shift in the economics and logistics of cell therapy.

INDUSTRY INSIGHTS CONTINUED

The CDMO Value Proposition For Your Autologous Cell Therapy

This panel session features a decade-long story of partnership in bringing two life-changing gene therapies to market successfully in 2022.

Optimal Tech For Predicting Drug Responses At The Cellular Level

Witness how preserving spatial molecular information and leveraging AI-driven spatial-omics can transform treatment prediction, patient stratification, and personalized medicine.

Master Cell Banks: Laying The Foundation To Final Product Success

By investing in the establishment and maintenance of a high-quality master cell bank (MCB), therapeutic developers can set themselves up for long-term success and ensure supply chain sustainability.

DoE-Based High Throughput Process For rAAV Manufacturing Development

This study presents the results of a Design of Experiment (DoE) approach to assess how these process parameters impact rAAV yield and quality.

A Platform For Stable LVV Production Cell Lines Yield

LVV manufacturing processes remain a significant hurdle for sponsors. Check out the potential of a packaging and producing cell line platform designed to enhance LVV manufacturing.

A Gateway To Europe: How Stevenage Supply Hub Supports ATMP Development

Ensure seamless access to European clinical trials and markets with GMP-compliant logistics, regulatory support, and risk mitigation to protect the integrity of your advanced therapies.

Beyond CRISPR: Next-Gen Gene Editing With TARGATT, Mad7, Base Editing

Consider several gene editing technologies — TARGATT, Mad7, and Base Editing — and gain insights into their transformative applications in genetic engineering and therapeutic development.

SPONSOR

Discover how CDMOs can help you achieve and maintain CMC compliance throughout the drug development lifecycle. Outsourced Pharma Live will explore how to leverage CDMO expertise in process optimization, documentation, and regulatory submissions. Learn practical strategies to align your CMC goals with CDMO capabilities to accelerate development and ensure successful drug launches. Registration is free thanks to the support of Curia.

SOLUTIONS

Capacity Update July 2024: Cell & Gene Therapy

Partner with ElevateBio BaseCamp to leverage the LentiPeak platform for high-quality, scalable lentiviral vector production and accelerate your cell and gene therapy development.

Manufacturing Life-Saving Gene Therapies

Take a look behind the scenes and hear firsthand about the commitment to patients and clients at Andelyn Biosciences.

Advancing CRISPR-Based Therapeutic Development

A CDMO that manufactures nucleases at research and cGMP grades can eliminate the need for custom manufacturing runs, simplify the transition to clinical application, and reduce regulatory paperwork.

Complete Solutions For Every Step Of Pharmaceutical Development

By combining disruptive technology platforms with unparalleled genomic medicine development expertise, we're positioned to accelerate the development of LNP formulations and drug products.

POSTmark AVV

Leverage POSTmark to streamline your path from R&D to cGMP-scale AAV production, reducing time, costs, and risks with a fully mirrored, scalable platform.

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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