Critical control points for conventional aseptic processing are most often related to contamination resulting from human intervention and exposure of critical surfaces before and during fill. Extensive resources are required to install and maintain controls for these typical failure modes which can lead to two critical issues: shortages of essential medicines and inability to meet the timelines critical to control emerging pandemic threats.
This article examines Thailand's history with biologics and biosimilars, as well as Siam Bioscience's perceptions of the current Thai FDA biologics and biosimilar regulations in relation to the U.S. and EU.
In terms of life sciences, Brazil is best known as a small molecule pharmaceutical market; some of the largest companies in Brazil are small molecule generics companies. But, in recent years, the country has identified the importance of establishing a biotechnology industry. Enter the productive development partnerships (PDPs).
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.
About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.
Critical control points for conventional aseptic processing are most often related to contamination resulting from human intervention and exposure of critical surfaces before and during fill. Extensive resources are required to install and maintain controls for these typical failure modes which can lead to two critical issues: shortages of essential medicines and inability to meet the timelines critical to control emerging pandemic threats.
When the U.S. Supreme Court granted certiorari in the Sandoz v. Amgen litigation earlier this year, many were hoping for a decision that would clarify some key issues pertaining to the requirements of the BPCIA. But the decision left a number of questions unanswered.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This four-part article provides a foundational introduction to some of those aspects.
It seems blockchain technology is following the hype path the cloud did a few years ago. The most talked-about example of blockchain is Bitcoin, a digital currency that does not rely on a central authority (such as the Federal Reserve) to clear financial transactions. A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.
Failures in data governance and data integrity have been more prominent in health authority enforcement actions in the past few years. Health authorities review thousands of pages of data in original submissions and supplements covering the broad GxP area. Inspectors then review manufacturing and test data on-site during pre-approval inspections and routine GMP inspections.
The modern biopharmaceutical/biotechnology manufacturing facility contains many sophisticated control, data logging, and data archiving systems. Massive amounts of data are collected from sources such as raw materials analysis, process outputs, and final quality assessments, which are stored in data warehouses.
Electronic lab notebooks (ELNs) are one of the primary scientific informatics solutions for helping scientists design, execute, analyze and report on experiments—but selecting the right ELN can be a challenge.
This article examines the five most common sources of printed packaging errors, why they’re likely to occur, and suggestions on how to prevent them.
Traditional Laboratory Information Management System (LIMS) implementations are notorious for keeping people awake at night. Industry analysts like Strategic Directions and ARC Advisory Group have estimated the failure rate of commercial LIMS solutions to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics. Adenovirus vectors are effective tools for the transfer of genetic material into mammalian cells. They offer several advantages, including the capacity to accommodate up to 37 kb of foreign genetic material, very high infection efficiency, ability to infect a wide variety of both dividing and nondividing cell types, lack of integration into the host chromosome, and availability of production systems capable of generating high virus titers.
Laboratory owners are constantly challenged to create new research environments with limited budgets and few resources. In addition, consideration has to be given to the “triple bottom line” (people, planet and profit), within these strict budgetary constraints. Cost-conscious owners want facilities to meet their vision and business objectives while also including flexibility, efficiency, safety, and robust utility/engineering systems.
Philip Lyman, PhD – Director of Process Simulation at CRB – discusses how a process model, at the right detail level and properly validated, can be an invaluable tool to compare alternatives and justify cost for manufacturing and manufacturing-related processes.
