Newsletter | August 12, 2025

08.12.25 -- CDMOs Should Stop Stringing Biotechs Along

INDUSTRY INSIGHTS

Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

Strategies For Developing Robust AAV Platforms

Explore advanced production platforms that enhance efficiency, scalability, and compliance, paving the way for safe and accessible gene therapies.

3 Key Bottlenecks In Supply Chains

Ensure your cell therapy program is prepared for the future by learning how to effectively navigate sourcing, logistics, and manufacturing challenges with confidence.

FEATURED EDITORIAL

CDMOs Should Stop Stringing Biotechs Along

Biotechs, first working closely with a CDMO’s sales manager, experience subsequent and sudden rejections of their projects. Did some of you just wince? If so, that might be because we are again hearing of a problem with sudden rejections after protracted discussions and even site visits. Part two on what is one of the biggest problems for outsourcing today.

The Building Blocks Of A Robust Analytical Assay

Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

INDUSTRY INSIGHTS CONTINUED

Securing A Treatment Through Grit And Collaboration

Discover how one family defied the odds—bringing a lifesaving gene therapy from idea to treatment in just 14 months after a devastating rare disease diagnosis.

Making The Case For Case Management In Cell And Gene Therapies

It is crucial to ensure that CGT supply chain risks are mitigated, as well as to have proactive strategies in place to address unforeseen challenges before they become an issue.

How The Pharma Industry Is Closing Health Inequities

Witness as pharma leaders discuss advancing equity through inclusive trial design and global partnerships to overcome health disparities and expand access to lifesaving therapies worldwide.

Analytical-Driven Cell Therapy Development

Examine the escalating rigor from assessing feasibility in preclinical studies to fully validated release methods and lifecycle management in commercial supply.

Mammalian Cell Engineering For Difficult Protein Expression

By leveraging cells equipped with an existing TARGATT™ landing pad, we demonstrate how inducible expression can be efficiently achieved within just 4-6 weeks after donor plasmid creation.

Enhancing The Upstream Performance Of AAV Vector Manufacturing

Unlock the potential of AAV manufacturing by leveraging data-driven insights and the advanced Pro10™ platform to optimize processes, enhance productivity, and drive innovation in cell and gene therapy.

LC/MS Method For Measurement In Human Plasma

Gain insight on how this plasma-based measurement has the potential to serve as a critical pharmacodynamic biomarker, facilitating the assessment of novel therapeutic approaches.

Combining An MVA Technology Platform With Innovative Methods

Learn how this process development platform for MVA impacts vaccine manufacturing and supports the drug life cycle from process and analytical development through trials and commercialization.

How Integrated Data Systems Enhance Clinical Development

Delve into how cloud-based systems and unified data platforms are transforming biomanufacturing by enhancing efficiency, ensuring quality, and accelerating the delivery of complex therapies to market.

SOLUTIONS

Capacity Update April 2025: Cell & Gene Therapy

Consider how an intensified adherent AAV manufacturing process is unlocking high-yield, low-impurity clinical production with over 95% full capsids in a streamlined, compact platform.

Expert Cell Banking Solutions

We offer comprehensive technology platforms and services to expedite the discovery, development, testing, manufacturing, and commercialization of clients' pipeline.

Advancing Innovations For mRNA Medicine Pioneers

Translating mRNA sequences to a high-quality drug product presents a complex challenge. Observe how partnering with a single contract manufacturer can alleviate potential delays and risks.

Phase-Appropriate, Tailored 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.

Allogeneic And Autologous Cell Therapy CDMO Services

As a CDMO Partner for Life, our goal is to advance your cell therapies from lab to commercial scale, leveraging our cell and gene therapy expertise and global cGMP network.

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: