Newsletter | March 25, 2025

03.25.25 -- How Do We Categorize CDMOs?

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Explore how shifting demand for oligos and peptides is driving outsourcing relationships and innovation in CDMO partnerships. Join our next Outsourced Pharma Live as we cover best practices for outsourcing these specialized therapeutics, focusing on capacity, regulatory challenges, and technology transfer. Register today to learn about the unique challenges and opportunities in scaling production for these complex molecules.

FEATURED EDITORIAL

How Do We Categorize CDMOs?

Are we on the same page? Do we need to be? That is, how do we differ on what might seem like the mundane defining of CDMOs as small, medium, or large? Some readers have been asking. How might this determination be relative and important to individual sponsors? Our Advisory Board members weigh in.

UK MHRA Draft Guidance On Individualized mRNA Cancer Immunotherapies

The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.

INDUSTRY INSIGHTS

Harnessing mRNA Quality Insights: Techniques For Rapid Drug Development

Chief Scientific Officer and Founder Christian Cobaugh, Ph.D., examines the critical quality attributes of mRNA and LNPs that are pivotal to enhancing drug efficacy and safety.

Upstream Optimization Paved A Straightforward Path For Full Capsids In AAV6

Because clinical applications for AAV are increasing rapidly, there is a high demand for further increasing yields as well as product quality, particularly for a higher percentage of full capsids in the final product.

Integrating Analytical Method Development And Quality Control

With the advancement of cell and gene therapies, a well-integrated analytical framework will be critical for accelerating development timelines and optimizing regulatory submissions.

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.

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.

Overcoming Challenges In AAV And LV Viral Vector Manufacturing

Manufacturing viral vectors leaves sponsors vulnerable to high costs, delays, and the possibility of failure. The right CDMO partner can help you reduce timelines and costs for viral vector production.

Scalable Suspension LVV Production Platforms

Review a scalable suspension-based Lenti production platform using a proprietary HEK293T clonal cell line and improvement steps to generate commercially viable therapies from concept to patient.

Next-Generation CRISPR Approaches

By providing essential components like nucleases, gRNAs, and HDR templates, a reliable CDMO facilitates a seamless transition from discovery research to clinical trials and beyond.

5 Key Strategies For Transferring Potency Assays From Lab To GMP Production

With extensive experience in managing assay transfers across diverse sources and development stages, we have identified five critical factors that can significantly impact their success.

The Role Of Downstream Processing In Optimizing RNA-LNP Drug Development

Uncover the key aspects of lipid nanoparticle (LNP) development, including the essential downstream processes of Tangential Flow Filtration (TFF) and normal flow filtration.

Alerion Microbubble Cell Separation System Used For T Cell Negative Selection

Here, we look at how the Alerion™ Microbubble Cell Separation System outperformed standard magnetic methods in T cell recovery, speed, and scalability — achieving higher cell quality.

SOLUTIONS

Enabling The Outcome In EMEA

With our global network of facilities and services, Cryoport Systems is a strategic partner of choice for temperature-controlled supply chain management of critical materials.

Two-Sided Pharmaceutical Labeler: HERMA 362C

The HERMA 362C is a compact and flexible two-sided labeling machine designed for quick and easy changeovers. It operates largely without format parts, accommodating a wide range of product formats.

Stand-Alone Fill/Finish Service Offering

Review our technical capabilities and specifications and discover how a partner with fill-finish services designed to take advantage of 100% of the product can guide your product to commercial success.

Capacity Update January 2025: Cell & Gene Therapy

Consider the structure and capabilities of our Laboratory Services group for your next project, a cornerstone of our commitment to excellence in pharmaceutical development.

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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