Newsletter | May 27, 2025

05.27.25 -- Lilly's CEO Building On The Trump Agenda

INDUSTRY INSIGHTS

Overcome The Challenges Of Designing A QC Program For New Modalities

Stringent QC release testing throughout biologic production, as mandated by health authorities, ensures product safety and quality through evaluations of identity, purity, potency, and critical quality attributes.

Caring Cross: Boro Dropulić's Big Idea That Might Change The World

With real-world examples and a vision that challenges the prevailing norms of biotech commercialization, this conversation offers a powerful look at what it takes to reshape the future of healthcare.

Promoter And PRE Triage For Gene Expression And Function Optimization

This study demonstrates the effect of different promoters and PREs (Post-Regulatory Element) on multiple CAR and transgenic TCR constructs on titer, integration, expression, and in vitro function.

FEATURED EDITORIAL

Lilly's CEO Building On The Trump Agenda

“We hadn’t built a new site in the U.S. in more than 40 years until the first set of Trump tax cuts, so we need to see those either extended or improved to support this,” Eli Lilly CEO David Ricks recently said, announcing — in Washington, DC — plans to invest $27 billion to build four new manufacturing plants in the U.S.

The Secret To True GMP-ness In The Cell & Gene Therapy Sector

Much of what we do in cell and gene therapy manufacturing is deeply habit-based. When employees understand the purpose behind a task, it supports their autonomy and competence.

INDUSTRY INSIGHTS CONTINUED

A Focus On Cell Therapy: CAR-T, CAR-NK, And Beyond

As the landscape of CAR T-cell therapies evolves, these treatments are becoming more precise in targeting cancer cells and overcoming production challenges, and are poised to revolutionize oncology.

Key Challenges In mRNA Manufacturing

Manufacturing mRNA products is a complex and challenging process that requires careful consideration at each stage. Learn more about the challenges and intricacies involved.

Surface Plasmon Resonance for Biomolecular Interaction Analysis

Explore how uncovering molecular interactions can drive breakthroughs in disease understanding, drug discovery, and therapeutic innovation.

Set Your Cell & Gene Therapy Program Up For Success From Day One

Partner with a specialized CDMO early in developing your cell and gene therapy to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.

Working With An End-To-End CDMO To De-Risk AAV Production

Uncover how the strategies outlined here can optimize AAV manufacturing by reducing risk and balancing productivity, quality, and cost to meet the growing demands of gene therapy.

Partnering For Success In Oncolytic Virus Development

Learn how to navigate decision-making at critical steps and find solutions to key challenges in process development and scale-up to expedite oncolytic virus programs.

Key Analytical Considerations For Developing A Clinical AAV Program

Unlike traditional drugs, AAV therapies require extensive characterization and testing, demanding varying degrees of analysis at each stage of development.

Super Short Activated CAR-T Process

Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.

SOLUTIONS

Groundbreaking Cryogenic Freezer Technology

Examine the benefits of a new cryogenic storage tank and how this innovative technology will mitigate risk in the cell and gene therapy supply chain.

Phase-Appropriate, Tailored Process Development Support

In cell and gene therapies, your process is the product. Our team of experts develops, defines, and refines processes for maximum efficiency and scale.

See How We Bring Biotech Innovation To Life!

Affinity is the driving force behind everything we do. It's reflected in our deep commitment to our clients, our dedicated teams, and ultimately, the patients who depend on life-changing therapies.

Gene Editing Services

With over 1,800 unique cell line models engineered by the scientists and technology developers at Applied StemCell, you can be confident in the quality and reliability of our service.

Small Scale Feasibility

With a simple quote and 10 mg of your research grade transgene plasmid, Viralgen can perform a small scale feasibility study, including downstream purification.

Capacity Update July 2024: Cell & Gene Therapy

Partner with a trusted manufacturing services partner for cell therapy companies. We provide expert services, including access to CMC development and clinical manufacturing for cell therapy.

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.

Connect With Outsourced Pharma: