Whether improvements in the delivery of training in biopharmaceutical manufacturing are needed is an open question, and the answers are not clear-cut. BioPlan recently conducted independent research to address this question.
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.
Whether improvements in the delivery of training in biopharmaceutical manufacturing are needed is an open question, and the answers are not clear-cut. BioPlan recently conducted independent research to address this question.
The core mission of the pharmaceutical industry is to manufacture products for patients to cure them, vaccinate them, or alleviate a symptom, often by manufacturing a liquid injectable or an oral solid, among other therapies. In this article, we will focus on the aseptic injectable, from a general standpoint, to see what we are doing with our aseptic filling systems and why.
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. 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. 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 pharma industry is increasingly looking for approaches that shorten drug development timelines and save on cost, especially virtual biotech companies who rely heavily on key milestone payments.
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.
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.
Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.
To take advantage of the growing HPAPI market, a company must have the proper controls in place to safely handle these potent compounds and successfully bring its drug to market.
Avoid inconsistent and even dangerous dosages being tableted by monitoring segregation during the process.
