Part 3 of Identifying And Resolving Errors, Defects, And Problems Within Your Organization — a five-part series on operationalizing proper improvement techniques.
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.
Part 3 of Identifying And Resolving Errors, Defects, And Problems Within Your Organization — a five-part series on operationalizing proper improvement techniques.
Probably one of the most significant developments in sterilization and aseptic practices in the pharmaceutical business is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.
The EMA Q&As and their updates mark an important turning point in the pharmaceutical industry regarding cleaning validation and quality risk management. The new ASTM standards will provide guidance to the industry on the appropriate development of health based exposure limits, for the implementation of science- and risk-based approaches to cleaning validation, and on the use of statistical techniques for measuring the risk in cleaning and assessing the effectiveness of cleaning processes.
The new trade regime unleashed by President Trump has not only heightened trade tensions, it has the potential to affect patient access to affordable medicines. His administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted foreign governments “freeriding” off of American investment in innovations.
Bioburden and endotoxin testing traditionally have been performed retrospectively, and only through sufficient validation and historical data is sufficient confidence developed. Online water bioburden analyzers (OWBAs) have the potential to eliminate sampling and testing errors via reduced manipulations.
Lab automation equipment makers should keep outsourcing strategies flexible as "make‐versus‐buy" decision drivers change. This article offers four factors to help in outsourcing decision making.
What is the only thing on retailers and manufacturers’ minds more than safety? The economy and consumer demand, which translates to profitability. In a competitive world market, made even tougher by recent legislation in major markets such as the U.S. and China to reassure consumers, producers at every point in the supply chain are carefully watching margins while seeking new strategies to protect market share.
How factors such as R&D vs. production press as well as compaction dwell time can affect your scale-up.
If the glass vial for a biologic drug experiences breakage, or does not maintain container closure integrity, a cyclic olefin polymer (i.e., Daikyo Crystal Zenith COP) system may be the solution.
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.
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.
Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge.
