Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This four-part article provides a foundational introduction to some of those aspects.
It seems blockchain technology is following the hype path the cloud did a few years ago. The most talked-about example of blockchain is Bitcoin, a digital currency that does not rely on a central authority (such as the Federal Reserve) to clear financial transactions. A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.
Cleaning manufacturing equipment to prevent cross contamination of pharmaceutical products is a fundamental aspect of GMPs. Validation of cleaning processes has been required within cGMP industries for a long time and is recognized as an important activity to establish that product cross contamination is controlled to ensure patient safety and product quality.
Payer receptivity to high orphan drug (OD) prices and, hence, revenue, will almost certainly begin to wane as budgets are increasingly strained by new therapies and as payers increasingly scrutinize the value of ODs. Indeed, there are signals that payers are becoming increasingly sensitive to the cost of newly approved ODs, even those that confer a clear clinical benefit to patients.
Successful implementation of quality by design (QbD) can lead to significant revenue growth and margins from the shortened development cycle. However, in our recent reports on the state of ICH Q8-11 guideline adoption in the industry, we confirmed that, despite the sound rationale of the new operating paradigms, industry uptake has been slow since the publication of the guidances nearly a decade ago.
Understanding the proper role of social media is an important challenge for pharmaceutical companies when it comes to “connecting” with potential patients and building their levels of trust. In 2017, strategies that involve traditional mass media — such as TV and print ads — are far from dead; however, social media offers clear advantages to building recognition for a drug — and awareness of its efficacy — in ways that can be targeted to very specific audiences. This typical challenge of targeted outreach is made considerably easier for companies thanks to the significant amount of personal content choice that both social and digital media platforms offer patients who are doing their personal health research.
India and China represent nearly 40 percent of the world’s population, so their domestic markets for biologics alone represent a remarkable opportunity. However, currently, the opportunities for sales of biological therapeutics remain in more developed countries.
In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects.
In the ongoing battle to cut costs while delivering quality and technically sound product, the biotech industry has spent the past two decades gradually moving toward single-use pre-sterilized plastic equipment for both clinical batch and, where applicable, production scale manufacturing. Single-use process equipment can be used and then disposed of, eliminating the development time to validate the sterilization and in-facility sterilization downtime, as well as development time to qualify and verify the cleaning and commensurate cleaning downtime.
Prior to the passage of the Orphan Drug Act of 1983 (ODA), a meager 38 orphan drugs (ODs) were approved, corresponding to — at best — an approved drug for less than 1 percent of an estimated 7,000 orphan diseases.