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.
Working towards a goal to define current good practices providing information to allow organizations to benchmark their practices and improve on them.
Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.
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.
Not Seen on HGTV: Method Design for Cell Assays. The many decisions when designing cell-based potency assays make home remodeling look easy.
To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.
Biotech firms often have tight timelines to prove the concept of their NCE. As a result, modern clinical development pathway requires rapid manufacturing of the “first Kilo”.
As an indicator of the suspension quality of various pharmaceutical products, using the measurement of zeta potential to yield the best products is of primary importance during product development.
Using new approaches to process development and associated equipment, engineering and business models to increase efficiency and reduce costs.
