Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. This article will address concepts of environmental monitoring and the importance of disinfectant efficacy and proper cleaning in cleanrooms.
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.
Relocating an organization as large as the EMA, which employs upwards of 1,000 people in London, will be no easy feat. As such, IDA Ireland, an agency that supports companies in Ireland and promotes foreign direct investments in the country, is working to compile information on why Ireland would be a good location for the EMA.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. This article will address concepts of environmental monitoring and the importance of disinfectant efficacy and proper cleaning in cleanrooms.
Artificial intelligence (AI) has truly moved from concept to reality in the pharmaceutical industry. Many companies are already using AI to pour through mountains of scientific data in an effort to speed and improve the drug discovery process. And the technology is starting to find new applications in areas as diverse as regulatory/compliance, clinical trials, manufacturing, and supply chain.
The word “quality” is bandied about with reckless abandon across the healthcare, clinical practice, pharmaceutical, and biotech industries. Everyone thinks they understand quality at a deep level, just like everyone thinks they are “better than average” drivers.
The biopharmaceutical industry has unique commercial risks, including complex molecule products, costly supply chain infrastructure that takes a long time to construct, and raw material variations’ impact on process quality and yields.
This two-part article on biocontainment is a companion to our discussion of potent compounds, which focused primarily on chemically derived drug substances and drug components. While analogous to chemical potent compounds, biologically derived ingredients, intermediates, and products are produced by human manipulation of naturally occurring lifeforms and their byproducts.
A biosafety cabinet (BSC) is one of the most important pieces of equipment a laboratory that handles low-to-moderate risk biological materials. A BSC maintains a safe environment for personnel, and prevents cross-contamination of the work product. Among the many components determining the effectiveness of a BSC, the most critical is the air filter.
Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money.
Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.
By November 2017, pharma companies must be able to send each product’s transaction information, transaction history, and transaction statement (collectively known as T3 documentation) electronically.
Due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.
Process validation establishes the elasticity and restrictions in manufacturing process controls to deliver upon the specified attributes of the dosage form while preventing undesirable results.
How to incorporate a new process into an existing facility is a basic question that begins every project. The client usually has a preconceived idea of where a new process will go and how much space is available, but if we stop here and do what we are told, preconceived notions may drive us to a point where we find that project needs haven’t been met.
