Newsletter | October 15, 2020

10.15.20 -- Considerations For Outsourcing, CDMO Selection, And Process Characterization

In-House Versus Outsource: A Decision-Making Guide

Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make those decisions.

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-stages 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.

Choosing The Right CDMO For Late-Phase Clinical Trials

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.

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 ensure your product meets regulatory requirements, enabling timely approval and launch to market.