03.17.25 -- Pain And Pleasure In Project Management Of CDMOs

Understanding the structural properties and impurities of biotherapeutic molecules is crucial for regulatory submissions and product development. As biotherapeutics become more complex, new analytical challenges emerge. This webinar covers advanced tools like mass spectrometry, biophysical characterization, and high throughput analytics to ensure safe, compliant medicines. Click here to learn more.

Explore how fostering a strong safety culture — rooted in accountability, collaboration, and proactive risk management — can drive operational excellence and long-term success in biopharmaceuticals.

This presentation provides an overview of oligonucleotide bioanalysis's current status and future directions. We will look into the advantages and disadvantages of various bioanalytical techniques.

By addressing considerations for a comprehensive reference standard strategy, manufacturers can ensure the integrity of biopharmaceuticals, ultimately paving the way for better patient outcomes.

During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.

Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

Learn how a fully disposable upstream and downstream platform process in antibody production can increase production timelines, enhance scalability, and reduce risk in biologics manufacturing.

Review the key principles of process intensification as a strategy for improving the efficiency and productivity of biologics manufacturing, including process modeling, control, and advanced analytics.

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

In this interview, SGS shares how its Hudson facility can enhance drug development processes by providing cutting-edge bioanalytical testing solutions and seamless global support.

In the U.S. and the EU, there are differences in the terminology used for combination products, as well as in the format and location of the information in the dossiers. This article proposes a harmonized approach for CTD Module 3.

Leverage customizable CMC solutions to propel your molecule toward IND filing and beyond, ensuring an efficient transition to the next stage of development.

By combining disruptive technology platforms with unparalleled genomic medicine development expertise, we're positioned to accelerate the development of LNP formulations and drug products.

Surrozen was keen to get started on process development and manufacturing and needed a CDMO with experience developing and producing bispecific antibodies and fusion proteins.

Follow along as Derek Ryan, Sr. Director of Analytical Development, showcases our high-throughput technology and digital tools for process understanding and optimizing decision-making.