Newsletter | March 24, 2025

03.24.25 -- AI Performance Management In Biologic And Drug Development

SPONSOR

Challenging the Norm: Smaller Partners, Bigger Impact

In our outsourcing industry, it is never an easy decision to select a partner when trying to run complex sequential trials. The need to gain regulatory approval for the treatments you have dedicated yourself to providing, coupled with the need to find a capable, reliable, and fair Contract Research Organization is quite daunting. Discover how a smaller full-service partner may be better suited to see your study through.

FEATURED EDITORIAL

AI Performance Management In Biologic And Drug Development

Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.

Agentic AI: The Next Leap In Biopharma Outsourcing And Manufacturing

Agentic AI is the next artificial-intelligence iteration for the biopharma industry. It propels prediction to autonomous decision-making. It can usher in transformative efficiencies to CDMOs. If you've day-dreamed of more effective external-support, this may be a ticket to that destination.

INDUSTRY INSIGHTS

Top 5 Approaches To The Bioanalysis Of Oligonucleotides

Evaluate the strengths and limitations of each bioanalysis method carefully to choose the most effective strategy for your clinical study.

The Execution Stage Of Technology Transfer

What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.

3 Ways To Maximize The Benefits Of Your CDMO Partnership

An experienced CDMO partner can help bridge the gap from lab scale to clinical and commercial scale while sharing the critical insights needed to launch a biologic manufacturing program.

Drug Product Process Characterization For Liquid And Lyophilized DP

Consider these important initial steps that should be implemented during the process design phase as a pre-requisite to a successful PPQ campaign and readiness for commercial manufacturing.

Advancements In Microbial Manufacturing Of Biopharmaceuticals

Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

Why Choosing The Right CDMO Partner Is Essential In Today's Market

Examine why it is essential for biotechs to choose the right contract development and manufacturing partner for drug development success in this market landscape.

How Oral GLP-1 Therapies Are Revolutionizing Obesity Treatment

In this interview, Dr. Srinivasan Shanmugam of Adare Pharma Solutions discusses the challenges, considerations, and impact of GLP-1 analogs for obesity therapy.

Overcome Global Medicine Shortages With Innovative Manufacturing

Looking to improve the resilience of your supply chain? Who isn’t? According to a report by Bain & Company, improving supply chain resilience will require redundancy, adaptability, and predictability.

Reducing Time To First-In-Human Trials With Robotic SFF Services

Discover how robotic gloveless isolator sterile fill-finish (SFF) systems can accelerate early-phase drug development, ensuring enhanced sterility and streamlined processes for biopharma innovation.

SOLUTIONS

Labeling And Kitting In The Pharmaceutical Industry

Pharmaceutical labeling and kitting are critical for ensuring drug safety, compliance, and efficiency. Utilize our advanced technology and regulatory adherence to streamline these processes.

Commercial Drug Sourcing For Clinical Trials

Learn how the right partner can leverage years of experience, market knowledge, industry relationships, and clinical packaging expertise to develop a sourcing strategy tailored to the needs of each study.

Scale Your Vaccine With Path-To-PAD

Our PAD program streamlines early development to maximize yields, leveraging vaccine expertise, robust expression platforms, and high-quality Vero and Quail cell lines.

Advancing Exosome Therapeutics: Scalable Production, Purification

As vesicular carriers, exosomes enable cell communication and are key to therapies involving cargo properties, targeting, and tissue-specific sources.

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: