Newsletter | March 3, 2026

03.03.26 -- With CDMOs Like This, Who Needs Biotechs?

SPONSOR

Join our experienced panelists as they break down how to transform your CDMO partnerships from sources of stress into strategic assets. Register for free thanks to support from Simtra. More info here!

INDUSTRY INSIGHTS

Annex 1: Sterility, Reinforced

Adhering to the rigorous standards set by the EMA's Annex 1 requires strategic, risk-based compliance for facility design and processes, all of which is key to patient safety and future innovation.

Strategies For Engineering Mammalian Cells

Using cells with a pre-engineered genomic landing pad, we achieve inducible expression within just 4-6 weeks after donor plasmid creation, significantly reducing development time and effort.

Smarter Analytics For Advanced Therapies

Review the advantages and limitations of transcriptional assays versus reporter gene assays and how the transcriptional assay compares to ddPCR and flow cytometry for analysis of CGTs.

FEATURED EDITORIAL

With CDMOs Like This, Who Needs Biotechs?

The question struck like a thunderbolt, writes Chief Editor Louis Garguilo. “Where are CDMOs going with all this?” asked Edward Ahn, CEO, Medipost, Inc., referring to the remarkable growth of some CDMOs. “When CDMOs aim to offer every service, capability, and the requisite capacities for an entire drug life cycle – from discovery to clinic to commercialization – what’s actually left for a biotech sponsor to do?” A forward discussion on an evolving outsourcing dynamic.

Active Versus Passive Shipping Solutions For Clinical Shipments

Explore active and passive temperature-controlled shipping solutions and their impact on clinical trial supply, balancing cost, risk, and product integrity.

INDUSTRY INSIGHTS CONTINUED

Microbubble Cell Separation For T-Cell Selection

Discover how a novel microbubble cell separation approach outperformed standard magnetic methods in T cell recovery, speed, and scalability — achieving higher cell quality.

AAV Transient Transfection, Producer Cell Line Platforms

The streamlined AAV transient transfection platform de-risks your path to IND and reduces complexity and timeline for lengthy process and analytical development.

xRNA Production: The Economic Case For Continuous Manufacturing

See how a continuous manufacturing platform streamlines production to days, uses real-time quality control, and dramatically cuts costs to accelerate access to new therapies.

Accelerating Gene Therapy Development For NEDAMSS

Assimilate how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

Building A Unique Portfolio Of Therapeutic Base Editors

Stepwise engineering produces ABEs with tunable potency, precision, PAM range, and context specificity, enabling robust and targeted genome editing across diverse therapeutic sites.

Modern Lentiviral Platforms For Scalable Cell Therapy

A new platform approach streamlines lentiviral vector design and manufacturing, boosting yield, lowering costs, and accelerating access to gene‑modified cell therapies worldwide.

Optimization For AAV Manufacture Efficiency

An optimized platform boosts AAV yields up to 30-fold, improves capsid quality, and reduces costs by 85%, enabling scalable, contamination-free manufacturing for advanced gene therapy applications.

SPONSOR

Explore 20+ new CDMO presenters in quick 20-minute sessions during the Outsourced Pharma Capabilities Update. Sessions include Analytical Services, ADC, Large and Small Molecules, Cell and Gene Therapy, and Fill/Finish. Each session offers a quick, informative look at capabilities to help you find the best-fit partner. Registration and on-demand access are all free! Click here to learn more.

SOLUTIONS

Your CDMO Partner From CMC Development To Commercial Supply

Choose a platform that offers clients a personalized, responsive, and expert-driven approach to process development and manufacturing from early clinical to pivotal supply and commercial launch.

Plasmid DNA Platform

Whether your program requires research-grade (RG), high-quality (HQ), or GMP-grade pDNA, we provide manufacturing solutions backed by quality control, regulatory expertise, and full traceability.

Comprehensive, Integrated BioServices

With decades of expertise in logistics and a scalable global infrastructure, we leverage purpose-built facilities and advanced technology to serve as the trusted partner for your BioServices needs.

Compliant Storage For Chemicals, Process Liquids, And Buffers

Maintain material quality and integrity with storage facilities compliant with ISO 9001, cGMP, and GDP standards. Features include real-time temperature control and HAZ-class segregation.

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecules share their capabilities and available capabilities. 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: