This article will focus on approaches used to manage infections caused by common pathogens, the current landscape of targeted antibacterial therapy, and the challenges and areas of opportunity for both developers of antibacterial therapies and manufacturers of medical devices.
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.
This article will focus on approaches used to manage infections caused by common pathogens, the current landscape of targeted antibacterial therapy, and the challenges and areas of opportunity for both developers of antibacterial therapies and manufacturers of medical devices.
The revised format for the EU Risk Management Plan sets a new milestone in a progressive approach to risk management. The new RMP template is a straightforward and well-structured document that can be used by RMP experts, and the concepts behind risk management have been justified to better reflect the stages of the life span of a medicinal product.
Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. If disinfectants are not used properly, microorganisms may remain on surfaces and proliferate in the environment. This article discusses the concept of disinfectant rotation and the current mainstream industry practice regarding it.
Having a competent, professional workforce is essential to meeting the dual goals of business requirements and regulatory expectations. With a coherent plan and a well-structured learning system that is focused on performance, a pharma firm can efficiently accomplish both.
Among the current and emerging topics of interest to the pharmaceutical industry, quality metrics, quality culture, and data integrity are of particular concern to both the industry and regulatory authorities.
While real-time viable particle counters offer significant potential benefits, they also present some new challenges to industry and regulators. This article will address the unique challenges associated with evaluating, testing, and validating this new family of RMM instruments.
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.
The importance of optimizing the chemical synthesis and formulation processes in complex molecule development.
This paper explores design arrangements to cope with higher-load applications and identifies design considerations observed during the development of a high-load, twin rail system.
Manufacturers can benefit from this alternative transfer technology that has now been adapted to solve issues in aseptic handling.
Through a successful implementation, Fujifilm was able to not only recognize the benefits an integrated automation platform offers but also the importance of working with an experienced partner.
Every pharma company handling HPAPIs needs to establish an occupational exposure limit, or OEL. These are based on hazard classes called occupational exposure bands (OEBs).
