Some equipment, such as shell and tube heat exchangers, can be difficult to clean without a CIP system, but it is crucial that it is done regularly and effectively to prevent contaminated products.
The pharmaceutical industry reached some new heights in 2014, according to the 2015 CMR Pharmaceutical R&D Factbook from Thomson Reuters. Global sales reached $1 trillion, and they are expected to continue to rise.
Sales growth increased more than 3 percent, a sign of good health in the industry. Plus, Thomson Reuters predicts that, by 2018, sales will reach $1.3 trillion.
“Many new molecular entities that launched in 2014 were for specialty pharmaceuticals.”
Also in 2014, the largest number of new molecular entities in 17 years came on the market, with 46 launches. Many of these launches were geared toward cancer treatment. More than two-thirds of NME launches were for specialty drugs meant to treat diseases like cancer and eye disorders. One-third of all launches were for rare indicators, such as cancer. Plus, 11 NME launches were geared toward oncology and seven received an orphan drug status. According to the U.S. Food & Drug Administration, this means they will be used for the treatment of diseases that fewer than 200,000 people in the U.S. have, or for those diseases where the cost of developing a treatment is not expected to be recovered.
Specialty drugs improve market
Drug, Chemical & Associated Technologies Association explained specialty products had a large part in market growth over the past few years, and will continue to do so in the years to come.
One of the biggest specialty sales of 2014 was Gilead Sciences’ Sovaldi, or sofosbuvir, which is used to treat hepatitis C virus. HCV treatments were some of the new NMEs that were launched that year. According to DCAT Connect, Sovaldi sold $10.28 billion worldwide in 2014 alone.
Specialty products aren’t just having a positive effect on pharmaceutical sales in the U.S. DCAT Connect explained these are also boosting the market in pharmerging countries, or those developing nations that are quickly beginning to use more pharmaceuticals.
Stay up to date
As more specialty pharmaceuticals are developed, and as more nations begin using these and pharmaceuticals in general, it is important that all companies maintain high quality standards. This is the best way to ensure products are safe and effective.
“All equipment should be maintained and calibrated properly.”
The FDA recommends that all equipment be maintained and calibrated properly, and regularly checked. The administration warns that some equipment should be replaced or upgraded if they no longer meet today’s standards. Anyone who operates equipment, such as shell and tube heat exchangers, needs to be properly trained. This includes the proper way to clean and inspect the equipment. Some equipment, such as shell and tube heat exchangers, can be difficult to clean without a CIP system, but it is crucial that it is done regularly and effectively to prevent contaminated products.