The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.
Cold is undeniably the new normal for the biopharmaceutical industry. By 2020, greater than half of bestselling drugs will be cold-chain products, most of which are injectable.
A single-source CDMO that manages the end-to-end relationship with pharmaceutical or biopharmaceutical clients can bring many benefits and efficiencies to the development process.
A single vendor CDMO offers access to a network of experts across several disciplines who can share knowledge about a project as it moves from phase to phaseon a path toward commercial success.
In the pharmaceutical industry, speed is of the essence. As drug developers face increasing pressure to get formulations to market as efficiently as possible, the CDMO industry is evolving to meet this need.
As drug developers face increasing pressure to get their products to market as quickly as possible, the CDMO industry is evolving to meet this need by offering end-to-end services.
With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.
The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30% of compounds successfully transition from Phase II to Phase III.
Drug substance characterization is critical to drug product formulation but characterization and formulation are often not integrated during drug development.
As drug companies have fewer and fewer new compounds entering their R&D pipelines, outsourcing of development and manufacturing activities for oral solid dosage forms and sterile forms is on the rise.
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