The drive to reduce costs, increase speed to market, and meet regulatory requirements has led many pharmaceutical companies to look at single-use, pre-sterilized, plastic equipment systems as an alternative to stainless steel lines. Single-use equipment makes the biomanufacturing process increasingly efficient and less costly.
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 drive to reduce costs, increase speed to market, and meet regulatory requirements has led many pharmaceutical companies to look at single-use, pre-sterilized, plastic equipment systems as an alternative to stainless steel lines. Single-use equipment makes the biomanufacturing process increasingly efficient and less costly.
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.
Successful qualification and documentation processes start in the planning phase of a project, follow through manufacturing and lifecycle of the equipment.
Productivity is more reliable when equipment can be monitored to detect incipient failures and take corrective action before the plant goes down.
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.
Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.
Understanding segregation and how it is related to drug development cost is at the heart of solving this issue and is the topic of this article.
Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies.
Consider these seven key parameters when selecting vacuum conveying technology.
