Active Pharmaceutical Ingredients (APIs) are the lifeblood of critical drug treatments and can make or break the sponsoring organization marketing them. But, getting a new drug from discovery through clinical trials to approval can take a minimum of ten years, with costs upwards of billions of ...
Pharmaceutical manufacturing has been flourishing in China recently and reminds us of the spirit of innovation and growth that took root in the U.S. in the 1980s and beyond. In fact, China is now the second largest pharma market, just trailing the U.S. What’s driving this growth is increased funding...
From the earliest civilizations to astronauts in space, drying out food to preserve it and retain vital nutrients has been a common practice. Today, the same fundamental strategy of lyophilization is becoming a key method used by drug and medical device manufacturers for the development of polymers ...
Why is it so important that assay and related substance methods for drug substance (DS) and drug products (DP) should be a stability-indicating method? The answer is two words, safety, and efficacy.
COVID-19 continues to take a toll at home and in business. As companies everywhere work to adjust to a new way of working, those of us in the Contract Development & Manufacturing Organization (CDMO) world may have an advantage. As essential work, many of us have maintained ongoing on-site operations...
The API manufacturing business can be a risky one – especially when dealing with chemical substances that will be consumed by humans. But it’s not only potent drugs that create risk for API manufacturers. Risk also can come from project delays or problems in the lab or plant that can derail projects...