11.25.24 -- October 2024 — CDMO Opportunities And Threats Report

Join us to understand best practices and explore real-world case studies in bioconjugates and ADC drug product development and manufacturing. You'll learn about new Drug Product High Potent capabilities from pre-clinical development to commercial supply and find out about flexible entry points with unique tailored approaches for every ADC phase. Click here for more information and to register.

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, including company and product acquisitions, product licenses and approvals, late clinical product terminations, and FDA rejections.

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.

Project managers must be technically adept enough to understand a project, but their main role is to ensure it delivers in terms of scope and budget.

See how companies are working to de-risk their device selection as they bring a new generation of high-volume, high-viscosity biologics to market.

Delve into the specific challenges encountered in the development of high-concentration formulations and gain an overview of current state-of-the-art solutions for subcutaneous administration.

Rapid development of high-quality cell lines is vital to biomanufacturing projects. How developers approach the fundamental steps can define their core biologics capabilities and keep projects on track.

As autoinjectors evolve to accommodate a diverse array of chronic diseases, consider the impact of partnering with experienced device manufacturers and fill/finish providers.

To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

Biopharma products in development continue to increase in complexity, which poses a challenge for pharmaceutical companies looking to improve speed and efficiency of biologic development.

Explore how KBI Biopharma’s SUREtechnology Platform™, powered by Selexis®, accelerates the development of complex biologics from early stages to FIH trials, focusing on both speed and quality.

Consider how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing risks.

Join us on December 2nd to explore mRNA construct development at Lonza, focusing on cGMP manufacturing, analytical advancements, and testing methods. Gain insights into the transition from research to manufacturing and the technologies shaping mRNA development for future projects. Click here to learn more.

Utilizing Singota's International SCM services involves cost savings, risk mitigation, logistics support, and streamlined communication.

Experience customized and validated flow cytometry (FCM) biomarkers and panels for your clinical research on a global scale to enhance your research and development efforts.

Take a tour of our Cell Culture 1 facility and examine how each area is designed for maximum flexibility and includes multiple electrical and process gas drops for use with cell culture incubators.

Our advanced capabilities and state-of-the-art facilities in Waltham, MA, and Vilnius, Lithuania, can accelerate your projects from process development to cGMP manufacturing.

Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early and ensures the result is a product that is fit for purpose.

We serve more than half of the world’s leading biopharmaceutical companies, sharing their mission to expedite patient access to life-saving biologics.