Newsletter | September 29, 2025

09.29.25 -- Buckle Up. It's A Strategic Drive To Successful Sourcing

SPONSOR

Discover available CDMO capacity for critical fill/finish services, including sterile filling, lyophilization, and advanced packaging, at the Fill/Finish session of the Outsourced Pharma Capacity Update (Oct. 10). This virtual event highlights technologies and quality standards essential for safe, effective biopharmaceutical delivery. Engage in short, interactive presentations and connect with CDMOs ready to support your manufacturing needs. Open to biopharma companies, consultants, and investors seeking trusted partners for late-stage production. Save your spot today!

INDUSTRY INSIGHTS

Overview Of FDA's Expedited Program For Serious Conditions

Review details on the FDA expedited review programs, the incentives for obtaining such designations, and the required information/data to better position your investigational product for success.

Liposomes — Challenges And Opportunities

Liposome technology is an effective drug delivery tool but still presents difficulties. Learn how developers are meeting these challenges and the opportunities for advancement to maximize liposome usefulness.

Optimization Of A Glycosylation Analytical Method

Discover how combining experimental design with machine learning can streamline glycosylation profiling and accelerate the development of reliable analytical methods for therapeutic biologics.

FEATURED EDITORIAL

Buckle Up. It's A Strategic Drive To Successful Sourcing

Chief Editor Louis Garguilo says we bounce around the word “strategic” like a biopharma basketball. We’ve even got our own league. More professionals in our outsourcing industry include “strategic” in their titles than ever before. Starting with this editorial, he investigates what this exulted approach to working with external partners really means.

August 2025 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers, identifying CDMOs that might be impacted by key events affecting their clients.

INDUSTRY INSIGHTS CONTINUED

Pharmaceutical Supply Chain Management Best Practices

Explore strategies for effective supply chain management and overcoming modern supply chain challenges in the pharmaceutical industry.

Management Strategies For Adaptive Bio And Single-Use Excellence

Single-use technologies (SUTs) bring speed and flexibility to modern biomanufacturing, but realizing their full value requires robust, stage-specific risk management.

Improving Safety And Efficacy With Charged Variant Characterization

Did you know that a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic?

A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS

This unique model to predict injection force is designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.

Discovery Studies: The Foundation Of Drug Development Success

Combining rigorous target validation, early toxicity and pharmacokinetic (PK) testing, and an iterative design process is crucial for identifying viable drug candidates early.

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.

Unlocking Agility And Efficiency In Biomanufacturing

This standardized yet flexible modular biomanufacturing system is designed to accelerate timelines, improve scalability, and enhance quality while reducing costs and environmental impact.

SOLUTIONS

Large Scale Cell Culture Facility

With cutting-edge innovations like smart glasses for live process insights and a data-sharing portal, we're able to provide the capacity and expertise to bring biologics to commercial success.

End-To-End Capacity With Flexibility, Infrastructure, And Expertise

Whether scaling manufacturing capabilities, condensing supply, accelerating availability, or reducing the risk of a shortage, a manufacturing platform can be the difference between success and failure.

Capacity Update July 2025: ADC

Our collaboration with MilliporeSigma encompasses every stage, including bioconjugation, linker and payload supplies, formulation development, and final fill/finish of drug substance.

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: