The previous article in our "Identifying And Resolving Errors, Defects, And Problems Within Your Organization" series focused on identifying manufacturing trends so you can know when to act and when to let your processes run without interference. This one discusses what needs to happen when a defect or nonconformance is detected and needs to be investigated, explaining one of the most broadly applicable and durable root cause analysis tools: the fishbone diagram.
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 previous article in our "Identifying And Resolving Errors, Defects, And Problems Within Your Organization" series focused on identifying manufacturing trends so you can know when to act and when to let your processes run without interference. This one discusses what needs to happen when a defect or nonconformance is detected and needs to be investigated, explaining one of the most broadly applicable and durable root cause analysis tools: the fishbone diagram.
Pharma companies ignore the issue of counterfeiting and drug diversion at their own peril. If anything, the problems will tend to multiply as transnational clandestine operations continue to be involved in the highly lucrative counterfeit drug market. This article discusses noteworthy examples of how drug manufacturers of various sizes are tackling this problem.
The presence of visible particles in parenteral biopharmaceuticals remains a hot topic in the industry. Despite regulatory bodies targeting a goal of no visible particles, and despite industry’s focus on further improving the efficacy of inspection processes, particles will continue to be found during production and in the marketplace.
The U.K. has until March 29, 2019 to negotiate a deal with the EU to remain a member of the EMA. If no agreement is reached, MHRA has set forth the principles that will be in place on March 30 in case of a “no deal” scenario,including recently introduced new guidelines for the batch testing of medicines entering or leaving the U.K.
The question is no longer, “Will continuous manufacturing work?”, but “When will everyone be doing it?” But surprisingly, there are still many objections to continuous manufacturing within the biopharma industry.
Working towards a goal to define current good practices providing information to allow organizations to benchmark their practices and improve on them.
Purchase of new mixing equipment is typically not a hasty event. Unless an unexpected challenge abruptly hit your operations such as a sudden failure of an existing mixer or a right-now sales opportunity demanding an unprecedented spike in production, process engineers generally have time to prepare for what could be a serious expenditure. As with any capital investment, the purchase of a new mixing system ideally requires time and research. By Charles Ross and Son Company
How the expertise and resources of a strategic, equipment management partner can optimize your resource recovery when selling equipment.
Meeting the growing demand for fill-finish services requires specialized expertise, appropriate equipment and innovations in both emerging technology and business models.
Today’s drug delivery systems are complex technologies that require close teamwork between biopharmaceutical companies and their drug delivery technology partners to develop innovative platforms.
Biomanufacturing requires large volumes of buffers, and preparation of these liquids can quickly become a bottleneck. Here, two options that can help intensify your large-scale buffer management are presented.
Mergers and acquisitions among pharmaceutical companies, as well as an ever- changing product mix, lead to surplus capital equipment among pharmaceutical manufacturing facilities.
