Newsletter | May 5, 2025

05.05.25 -- From Lab To Launch: Smarter Strategies, Faster Trials, And Future Technologies

INDUSTRY INSIGHTS

Shifting Drug Development With Advanced Analytical Characterization

Explore the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver medicines in a safe, compliant, and efficient manner.

Reaching First-In-Human Trials Faster: Connect With The Right Partner

Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.

Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements

These studies validate cleaning protocols in pharma facilities, ensuring regulatory compliance, reducing contamination risk, and supporting safe, effective disinfection with expert CRO guidance.

FEATURED EDITORIAL

The Serious Business Of Working With CDMOs At Phase 2

You might call Anthony Grenier, Sr. Director CMC at Reunion Neuroscience, a "phase 2 outsourcing specialist." In this discussion, Grenier describes his experiences and presents some key factors and advice for biotechs at the middle stage of working with CDMOs.

8 Actions To Redefine Sponsor-CDMO Relationships

When viewing a CDMO as merely a service provider, interactions are often limited to completing tasks. This mindset can stifle innovation and problem-solving.

INDUSTRY INSIGHTS CONTINUED

Conduct Early-Phase Studies To Improve Manufacturability, Mitigate Risk

While clinical efficacy is the critical benchmark for any drug program, ensuring manufacturability is also vital. An experienced CDMO can help you establish efficient and cost-effective production strategies.

How To Maximize Cell Line Productivity And Efficiency

Review some of the key considerations in cell line development, how advances in technology are improving the efficiency and productivity of cell lines, and the future of cell line development.

Microbial Tech Transfer: Tips To Consider When Selecting A CDMO

Choose a flexible and experienced CDMO to ensure seamless scalability, diverse process capabilities, and expert analytical support for your microbial protein production.

Leveraging High-Pressure Sterile Filtration For Highly Viscous Solutions

This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

Protect Patients, Ensure Regulatory Compliance With Impurity Control

A sponsor’s commitment to impurity control throughout manufacturing is vital to ensuring continuous patient safety. E&Ls, nitrosamines, and PFAS are among the most critical impurities to test for.

Leveraging AI And ML For Better Biologics

For many bioprocessing applications, artificial intelligence (AI) and machine learning (ML) can be used in every phase of development to support optimization and streamline repetitive, effort-intensive processes.

SPONSOR

Discover how CDMOs can help you achieve and maintain CMC compliance throughout the drug development lifecycle. Outsourced Pharma Live will explore how to leverage CDMO expertise in process optimization, documentation, and regulatory submissions. Learn practical strategies to align your CMC goals with CDMO capabilities to accelerate development and ensure successful drug launches. Registration is free thanks to the support of Curia.

SOLUTIONS

Combining Scientific Knowledge And Advanced Technology

Your partner in contract production and development using the end-to-end business model. We specialize in the production of sterile biotechnological products in a manufacturing plant that meets GMP requirements.

Flexible Filling Capabilities For Rigorous Demands

Argonaut features state-of-the-art automated equipment for high-yield filling of sterile injectable drugs. Projects are supported by a full analytical quality control service offering, warehousing, and global shipping logistics. Equipped with advanced robotics, our automated fill line is specially designed to maximize product yield while minimizing the risks associated with operator intervention.

Supply Chain Management Insights

Singota has key partnerships to better serve clients. Singota works alongside Modality Solutions to provide clients insight into potential product degradation inflicted during the final product distribution process and provide transport validation support by utilizing Modality's Transport Simulation Laboratory (TSL).

Integrated Biotech Services: From Strain To Commercial Product

Backed by Lonza’s more than 30 years’ expe­rience and expertise in biological processing and our track record in the chemical and bio­technological industry, we offer our customers a full “one-stop-shop” service package at all stages of development and production.

Large Molecule Expertise. Ingenuity You Can Count On.

As a fully integrated CDMO, we offer a comprehensive suite of services, from early-stage research to robust commercial manufacturing, within our state-of-the-art facilities.

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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