Newsletter | May 22, 2025

05.22.25 -- Investors Create A U.S. Biotech With GLP-1 Assets From China

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We know how tough it can be to find the right CDMO, especially when capacity is tight and timelines are critical. That's why you’ll find our collection of recent Outsourced Pharma Capacity Update presentations so valuable. Our April Partners Week Update details the latest capabilities and available capacity from 40 leading CDMOs – and you can experience it all from the convenience of your screen. View the on-demand sessions for the modalities that fit your needs.

INDUSTRY INSIGHTS

Discovery Through Commercialization: A Biologic Drug's Analytical Journey

Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.

Effective Process Validation Accelerates Your Drug To Market

Discover how building a product development program with a long-term vision and adopting a holistic PPQ and CPV strategy from the outset are now crucial.

6 Ways Single-Use Technology Will Actually Save Time And Money

Utilize these strategies to develop a functional equivalence model for single-use manufacturing equipment and assemblies for use in drug product manufacturing.

FEATURED EDITORIAL

Investors Create A U.S. Biotech With GLP-1 Assets From China

The formation story of U.S.-based Kailera Therapeutics highlights the prowess of today’s investor class. All four of its clinical candidates are GLP-1-based therapies, all of which were licensed in China. Kailera's CTO, Doug Bakan, fills us in on how it came together and what's next.

Incorporating AI Tools Into Downstream Process Optimization

Data-driven, hybrid modeling complements mechanistic thinking by reducing computational load for faster decision-making when time is a critical consideration.

INDUSTRY INSIGHTS CONTINUED

Particle Investigation: Going One Step Further Than Just The Identification

Here, we review examples of visible particle identification, the root cause investigation, and the performance of additional troubleshooting using advanced and innovative technologies.

Ensure Speed And Success With Your Drug Delivery Project

Hear from experienced professionals in the drug delivery space on how to ensure success and speed-to-market by establishing a firm foundation when working with a CMO.

The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Be aware of the challenges of transitioning a promising drug candidate.

Maximizing Yield And Minimizing Risk In Aseptic Filling

In this study, we discuss the process of how a new fill line was planned for and implemented, while also considering how best to mitigate contamination risks.

Advanced Methodology Of PLGA-Based Parenteral Formulations

To enable the development of optimized PLGA-based sustained release formulations, this paper offers essential insights into the polymer’s properties, fabrication techniques, and drug release mechanisms.

Advancing Biomanufacturing Excellence Through Artificial Intelligence

Learn how AI is transforming the biomanufacturing industry and how partnerships between pharmaceutical companies and academic institutions are poised to set the new standard.

Collaboration For Clinical To Commercial Manufacturing Success

Begin your ADC manufacturing journey by finding a partner who can provide support through every phase of the conjugate life cycle, including process optimization, scale-up, and validation.

How Real-Time Data Access Enhances Collaboration With Your CDMO

Quality data for informed decision-making is well supported by a built-in network of lab digitization solutions and a commitment to the principles of data integrity.

Discover The World Of Digital Twin Technology

Step into the future of facility management with Digital Twin Technology and create a virtual replica of your facility or equipment to enable the highest levels of operational readiness and excellence.

SOLUTIONS

Robotic Pharmaceutical Labeling Cell System: HERMA 211R HC

With the robot-assisted labeling cell 211R HC, HERMA shows how challenges in wrap-around labeling can be solved more effectively. Discover the advantages of our HERMA 211R HC labeling solution.

A Friendly CDMO Expert: New CEO Outlines AGC Bio's Transformation

Experience a friendlier, more reliable approach to biopharmaceutical manufacturing with AGC Biologics, your trusted partner for minimizing risks and fostering collaboration.

Capacity Update January 2025: Large Molecule Development

Witness how our expertise and advanced capabilities provide customized analytical solutions that ensure quality, precision, and regulatory compliance for your biotherapeutics.

Are Your Supply Chains Resilient Enough To Roll With The Punches?

With a winning strategy encompassing safe, secure, and reliable supply chains to help you bring your therapy to patients, see how we can support your next project.

Formulation Development: The Key To Product Stability

Biopharmaceutical development hinges on a robust CMC strategy. Our expertise allows us to collaboratively design the optimal suite of analytical studies tailored to your specific molecule.

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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