The majority of biologic products today are launched as some form of combination product, stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.
This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development. In this installment, we will look at the areas of primary container, device development, device selection, and design control.
Respiratory diseases are an appealing target for future microbiome development, with the combined asthma and chronic obstructive pulmonary disease (COPD) market approaching $30 billion by 2020 in the U.S. alone, and with significant unmet needs remaining in both markets.
Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.
Drug manufacturers should be aware of new regulatory powers given to the FDA in a recently enacted law aimed at deterring opioid abuse. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) became law on Oct. 24, 2018 with bipartisan support in both the House and the Senate.
To navigate supplier and CMO consolidation, Isaac Young, senior director, supply chain operations, BioMarin Pharmaceutical Inc., offers some advice: Approach your outsourcing relationships like joint ventures. “As you have this greater engagement between two companies,” says Young, “you’re likely to enter an interdependent relationship. Why not acknowledge that rather than try to power-play or position one another?”
In recent years, several older opioid drugs have been reformulated and reintroduced to the market with great commercial success due to their ability to address significant unmet medical needs in the marketplace.
This article presents guided wave radar level measurement as an acceptable, less expensive alternate to load cell systems. By David Ladoski and Dan Klees
As with most scientific equipment, the freeze dryer (aka lyophilizer) is comprised of various components working in harmony to provide the researcher’s desired results.
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