The FDA has devoted significant time and attention to creating programs and guidance to assist manufacturers around the world in adopting emerging technologies. The agency has focused particular attention on continuous manufacturing (CM), which uses a more efficient process to manufacture drugs than the traditional multi-step batch process that has been prevalent for over 50 years. The idea of fostering the adoption of new technologies like CM stems from the hope that a more streamlined manufacturing process will improve the quality of drug products, thus eliminating shortages and perhaps even impacting price.
Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.
A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.
In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.
Pfizer's Bernie Huyghe and ADC Therapeutics' Michael Mulkerrin get bushwhacked with this question in a public forum. Their open replies will help each one of you to your own personal assessment. Be prepared for some soul searching.
The FDA has devoted significant time and attention to creating programs and guidance to assist manufacturers around the world in adopting emerging technologies. The agency has focused particular attention on continuous manufacturing (CM), which uses a more efficient process to manufacture drugs than the traditional multi-step batch process that has been prevalent for over 50 years. The idea of fostering the adoption of new technologies like CM stems from the hope that a more streamlined manufacturing process will improve the quality of drug products, thus eliminating shortages and perhaps even impacting price.
Last month, the FDA published the draft guidance “Principles of Premarket Pathways for Combination Products.” The document describes what a combination product is and how to interact with the FDA when developing a combination product, and it identifies some of the principles the agency uses in determining what type of premarket submission should be made.
The FDA issued the first warning letter citing failure to comply with requirements of the November 2013 Drug Supply Chain Security Act (DSCSA) amendments to the Food, Drug, and Cosmetic (FD&C) Act. This warning letter was issued to McKesson Corporation in San Francisco on February 7, 2019.
We often work with organizations adding capacity, transferring new products, and adding existing products from other sites into their “preferred” plants. These facilities range from CMOs to traditional name-brand pharmaceutical companies. In each case, the receiving site is focused on schedule and budget, and these competing targets have often distracted personnel.
It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.
Many of the advantages of mixing, blending and drying under vacuum have been recognized for years. But until recently, vacuum has also been widely misunderstood. Many processors have considered vacuum essential — and cost-effective — only for the most demanding applications.
Purchase of new mixing equipment is typically not a hasty event. Unless an unexpected challenge abruptly hit your operations such as a sudden failure of an existing mixer or a right-now sales opportunity demanding an unprecedented spike in production, process engineers generally have time to prepare for what could be a serious expenditure. As with any capital investment, the purchase of a new mixing system ideally requires time and research. By Charles Ross and Son Company
Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.
A solution to obtain structural information quickly for effective quality control of pharmaceuticals during production or to study ageing effects and other properties.
Understanding the impact of powder behavior during pre-formulation will ensure clinically effective products and provide critical process knowledge to design an efficient and reproducible manufacturing procedure.
When users make a mistake or interpret a critical matter incorrectly, they may hurt themselves, the environment, or the product. This article discusses ways to reduce human errors in food manufacturing.
The large buffer volumes required for biomanufacturing can be a bottleneck, especially when scaling up. Just-in-time buffer preparation can be the solution.
Cell-based potency assays don’t travel well. Here’s how to make their trip more pleasant from a non-GMP lab to a GMP environment.
