11.09.22 -- The Outsourcing Master Class

Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

Learn how and why a contract manufacturing and development organization (CDMO) that specializes in lyophilization relies on freeze-drying systems.

Determining the best single-use systems to implement in a given manufacturing operation requires a thorough understanding of both the process specifications and the capabilities of the component.

New assays that can more accurately predict how the human body will react to a drug candidate are now available, but their success is dependent on several factors.

The decision whether to develop and manufacture a drug in-house or to outsource comprises numerous elements, including costs, timelines, production capacity, and available resources.

This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.

Explore recent progress in continuous manufacturing and guidance for answering key questions related to implementation of continuous processing for late-phase development.                             

Custom-designed equipment and suites, flexible manufacturing lines, and alternative delivery and manufacturing approaches are critical to achieving a timely launch in a competitive marketplace.

Understand how to manage impurities in drug development with swift isolation, synthesis, and analysis. A client discovered an impurity during ongoing stability studies that exceeded ICH guidelines.

Explore a summary of the FDA’s recent draft guidance, Inspection of Injectable Products for Visible Particulates, and how it applies to components.

Time-to-experiment, time-to-clinic, and time-to-market are becoming even more important for developers and manufacturers of biopharmaceuticals. These tools make process development more efficient.

Complex CMO networks are expensive and require many resources to manage. Plus, they prevent purchasing and operating at scale. Yet, the process of consolidating CMOs is daunting.

To prevent delays and costly issues during molecular development, it is important to understand potential mechanisms of increased absorption with lipid formulations and the appropriate screening tools.

Learn about a scalable process for the production of rAAV using triple plasmid transfection of suspension cells in an animal-derived component-free medium.

Discover how clinical research services must wade through a bog of incomplete information, and sometimes outright misinformation, when it comes to seeking reliable partnerships.

Lonza Pharma & Biotech’s Dr. Raphael Frey and Dr. Sandro Holzer answer attendee questions from a recent webinar about the challenges when moving a bioconjugate candidate from early development to clinic.

Discover a breakthrough platform approach that encompasses the efficient production of bispecific molecules in an integrated, streamlined way, from cell line development to cGMP manufacturing.