Newsletter | October 5, 2026

10.05.26 -- CDMOs Co-Author The RNA Ecosystem

SPONSOR

 

Virtual Symposium: Developing Custom GMP Lipids: A Patient-Driven Partnership

From concept to GMP, bringing a custom lipid to production takes more than technical expertise. It takes collaboration. In this virtual symposium, Process Development and Manufacturing experts share how they worked together to navigate custom lipid design, scale-up, and regulatory challenges while maintaining quality and reliability. Discover practical insights for advancing custom lipid programs and supporting the development of next-generation LNP-based therapies. Click here for more.

INDUSTRY INSIGHTS

 

Balancing The Scales: The Ups And Downs Of Bioprocess Scale-Up

Delve into the complexities of scaling decisions to gain insights from biopharma developers and a CDMO. Learn about their mutual interest in achieving successful scale-up and strategies.

 

CDMO Partnerships: Why Speed And Flexibility Matter Now More Than Ever

As demand for GLP-1s and biologics accelerates, it's become crucial that pharmaceutical companies stay competitive and bring therapies to market faster by partnering with a CDMO.

 

Preparing Global Parenteral Sites For Annex 1 Compliance

Modern sterile manufacturing requires proactive quality risk management. Robust contamination control across facilities, processes, and supply chains supports compliance and patient safety.

FEATURED EDITORIAL

CDMOs Co-Author The RNA Ecosystem

Praise to the RNA innovators, and our innovative service providers. You’ve brought us a long way. Still, that progress hasn’t necessarily made it easier to strategize the outsourcing of specific RNA-based projects. We’ve expanded development programs therapeutically and dialed up nuanced production requirements. So the current question is what will the RNA outsourcing ecosystem look like a few years from now? Here’s some expert analysis.

 

Building Sustainable Biopharma Supply Chains Starts With Procurement

Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.

INDUSTRY INSIGHTS CONTINUED

 

Reducing Fill Risk In Drug Product Manufacture

How robotic, gloveless fill‑finish cuts aseptic risk, enables flexible containers, and scales manufacturing—connecting advanced automation to patient safety and operational efficiency.

 

De-Risking Automatic Visual Inspection (AVI) Through Integrated Validation

Aligning visual inspection systems with site standards prevents costly validation failures. Discover strategies to de-risk equipment startup.

 

Smarter CMC Strategies To Accelerate Next-Gen Biologics To The Clinic

Learn how process design and cross-functional collaboration mitigate risks and accelerate the path from early development to FIH manufacturing through real-world case studies of practical approaches.

 

The Gateway Delivery To The Brain

Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.

 

How Sponsors Should Evaluate Manufacturing Resilience

See how continuity planning, technology transfer capabilities, global network flexibility, and digital visibility contribute to resilient supply chains and help protect programs from disruption.

 

Overcoming Hurdles In Protein Therapy Manufacturing

Watch how biopharmaceutical leaders address scalability, quality control, and regulatory challenges when manufacturing protein-based therapies at commercial scale.

 

A Gene Expression System For Afucosylated Antibody Production

Use a gene expression system that allows you to produce molecules that are 100% free of fucose and demonstrate increased potency, without compromising on titers, growth, stability, or product quality.

SPONSOR

 

Webinar: Mission Control For Biologics Tech Transfer: Guiding process performance across sites, scales, and bioreactor systems

Tech transfer isn’t just moving a process from one place to another. It’s about ensuring process understanding and control can withstand changes in scale, equipment, sites, and teams. Explore how bioreactor characterization, scale-down models, in-silico modeling, and cross-site collaboration can uncover uncertainty before it becomes manufacturing risk and help protect product quality and timelines. Click here to learn more.

SOLUTIONS

Building Reliable Paths To Market For Large Molecule Therapies

Commercial Autoinjectors: Simplified Packaging Solutions

End-To-End CDMO Capabilities

Building Smarter Paths To Biologics Commercialization

Turning Screening Data Into Discovery Direction

NanoImprove The Performance Of Your Biologic Formulation

Services Designed To Take You From Molecule To Market

Link Your Antibody To Its Fullest Potential

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule 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: