Newsletter | June 11, 2020

06.11.20 -- Considerations For Selecting The Right CDMO

How To Pick The Right CDMO For Late-Phase Clinical Trials

Small contract development and manufacturing organizations (CDMOs) can often provide early-phase material but may not be able to meet the rigorous demands of late stage and commercialization. This article examines key criteria for selecting the right CDMO partner and includes a case study that shares the challenges involved in a late-phase technology transfer for a parenteral product.

What You Need To Know About Process Characterization And Validation For Biologic Processes

Even during the early drug discovery process, there are valuable opportunities to simplify the path to commercialization. Using a risk-based approach to generate an appropriate control strategy will help assure your product meets regulatory requirements, enabling timely approval and launch to market.

Process Characterization: Ready For The FDA?

Regulatory agencies see process characterization as an essential step in the commercialization of a new drug product since it not only enhances process understanding but, more importantly, patient safety. Realizing the benefits of process characterization requires proper planning and application of a comprehensive process characterization strategy.

Choosing The Right CDMO For Late-Phase Clinical Trials (Webinar)

For many pharmaceutical companies that do not have their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical aspect in the management of parenteral products. This webinar reviews the importance of finding a partner with extensive experience in the parenteral arena as products move through clinical phases and toward commercialization.

Telltale Signs You’re With The Wrong CDMO

Is your CDMO an asset or a hindrance? How can you recognize whether your partner really contributes everything they can to your end goal of commercialization? This article focuses on 10 red flags that could signal it is time to start looking elsewhere for a CDMO that can efficiently bring your project to commercialization while steering clear of potential roadblocks along the way.