Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone else is exhibiting a form of the psychological bias known as the bandwagon effect, in which they go along with the rhetoric because everyone else is.
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.
Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone else is exhibiting a form of the psychological bias known as the bandwagon effect, in which they go along with the rhetoric because everyone else is.
One of the most intriguing experiences we have had in our business in the last 20 years is being faced with a seemingly simple water-soluble topical or device component fill and then being told it is an organic peroxide! When we in our nice, safe water-based business (leave out liposomes) are faced with the compounding fire/electrical/OSHA compliances along with our GMP issues, it starts to read like a 1940s detective mystery.
Looking forward, it will be increasingly important for pharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets.
CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.
ASTM standard E2500, Specification, Design, and Verification of Pharma and Biopharma Manufacturing Systems and Equipment, elevates risk-based validation as a critical aspect of GMP manufacturing. This article explores validation’s role in efficiency and cost management, in an approach to ASTM E2500 from a scientific, value-added perspective
Uniformly dispersing powders into a liquid batch in a practical amount of time is a common problem for F&B manufacturers. This white paper explores five tips for dispersing powders more efficiently.
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.
In the rush to market, be aware of these critical missteps that can occur during the early development phases, in order to avoid major challenges later during commercial API scale-up.
Determine your plan now for serialization readiness to put the worries of DSCSA costs and timelines behind you and patient safety back where it belongs — at the forefront.
Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?
One solution to drug development challenges is adopting a parallel operations business model. This article offers recommendations for how parallel operations can be leveraged in a biomanufacturing strategy.
Mergers and acquisitions have come to define both growth and consolidation in pharmaceutical manufacturing over the last decade. Often, a merger or acquisition is the quickest, most cost-effective way to realize advanced capability without building a facility from the ground up. Buying specific capacity that either is lacking or will bolster a company’s overall offering generally makes more sense for both budgets and bottom lines — especially when dealing with an undervalued company. However, even a successful merger or acquisition of manufacturing facilities creates a range of asset management issues, including determining the fate of redundant operations and equipment.
