Nav: Home

A more safe and efficient means for drug manufacturing

June 15, 2017

Scientists have developed a system that uses continuous flow technology, instead of a batch-by-batch approach, to produce pharmaceutical compounds, and they used it to manufacture a chemotherapy drug that's currently under evaluation in clinical trials. Most pharmaceutical compounds are made in massive batches, yet small-volume continuous (SVC) manufacturing systems - currently used to produce numerous commodity chemicals - offer a number of advantages, such as improved safety and yield. As well, these systems can be used to conveniently produce pharmaceutical ingredients on site, when needed. Yet, while a number of SVC manufacturing systems have successfully produced pharmaceutical compounds in laboratories, few adhere to "current good manufacturing practices," such that they are commercially scalable. Here, Kevin P. Cole and colleagues developed a SVC manufacturing system that does adhere to such standards. The system allows for concurrent mixing of ingredients, and is equipped with fully automated filters that required no manual work, eliminating the risk of exposing operators to toxins. In this approach, a number of different techniques are used to separate layers of ingredients and effectively clean compartments after each use. The team demonstrated the effectiveness of their system by producing the chemotherapy agent prexasertib, currently being assessed in a phase two trial as a chemotherapy agent, in aqueous form. The system yielded 24 kilograms of the compound over the course of three days, the authors report.
-end-


American Association for the Advancement of Science

Related Clinical Trials Articles:

Giving children a voice in clinical trials
Children as young as 8 years old with incurable cancer can reliably characterize the impact an experimental therapy has on their symptoms and quality of life -- even at the earliest stages of drug development -- making self-reported patient outcomes a potential new clinical trial endpoint.
Better health for women involved in clinical trials
Women who participate in obstetric and gynecology clinical trials experience improved health outcomes compared to those who are not involved in trials, according to research by Queen Mary University of London.
Final artificial pancreas clinical trials now open
Clinical trials are now enrolling to provide the final tests for a University of Virginia-developed artificial pancreas to automatically monitor and regulate blood-sugar levels in people with type 1 diabetes.
Why the bar needs to be raised for human clinical trials
Standards for authorizing first-time trials of drugs in humans are lax, and should be strengthened in several ways, McGill University researchers argue in a paper published today in Nature.
New drug formulary will help expedite use of agents in clinical trials
The National Cancer Institute (NCI) today launched a new drug formulary (the 'NCI Formulary') that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials.
Review examines diversity in dermatology clinical trials
Racial and ethnic groups can be underrepresented in medical research.
Reshaping the future of global clinical trials practice
Researchers at the University of Liverpool have developed a new international guideline to help standardize how results from clinical trial studies are reported.
Fewer cardiovascular drugs being studied in clinical trials
The number of cardiovascular drugs in the research pipeline has declined across all phases of development in the last 20 years even as cardiovascular disease has become the No.
Sex hormones skew outcomes in clinical trials -- here's how
Clinical research often excludes females from their trials under the assumption that 'one size fits all,' that a painkiller or antidepressant will be equally effective in subjects of either sex, but a growing number of scientists are criticizing this approach.
Nearly half of pediatric clinical trials go unfinished or unpublished
Clinical trials in children commonly go either uncompleted or unpublished, finds a comprehensive study conducted by researchers at Boston Children's Hospital.

Related Clinical Trials Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Bias And Perception
How does bias distort our thinking, our listening, our beliefs... and even our search results? How can we fight it? This hour, TED speakers explore ideas about the unconscious biases that shape us. Guests include writer and broadcaster Yassmin Abdel-Magied, climatologist J. Marshall Shepherd, journalist Andreas Ekström, and experimental psychologist Tony Salvador.
Now Playing: Science for the People

#514 Arctic Energy (Rebroadcast)
This week we're looking at how alternative energy works in the arctic. We speak to Louie Azzolini and Linda Todd from the Arctic Energy Alliance, a non-profit helping communities reduce their energy usage and transition to more affordable and sustainable forms of energy. And the lessons they're learning along the way can help those of us further south.