Ed Price
Pharmaceutical manufacturing has been flourishing in China recently and reminds us of the spirit of innovation and growth that took root in the U.S. in the 1980s and beyond. In fact, China is now the second largest pharma market, just trailing the U.S. What’s driving this growth is increased funding for R&D from the Chinese government, more regulatory controls, and a surge in partnerships with major U.S. pharma firms. In addition, more U.S.- trained scientists are returning to China, along with senior-level U.S. biotech executives accepting positions with Chinese firms.
Dr. David Pearson
There are many reasons why it might be desirable to create a drug formulation using the salt form of an active pharmaceutical ingredient (API). Most commonly, it is because the solid-state properties of the API are not suitable for further development, which can lead to an increase in the cost, complexity or timeline for the project. It may be that the API is not crystalline, not thermally stable or insoluble, or it might be hygroscopic, so by making a salt, the API’s chemical makeup is altered in such a way that that all of these properties might be changed. For the most part, these changes will be beneficial, however, sometimes the opposite is true, which is why it is important to use a range of experiments and screening procedures to determine a salt form, and not just choose one.
Steven P. Adams
A growing number of inventive drug developers are turning away from large-batch, mass market developments toward the important and lucrative segment of small-batch, personalized medication and orphan drugs. Simultaneously, regulators continue to increase the complexity of regulation, especially in-data recording, traceability, and cGMP. As a result of these two phenomena, drug development and production costs climb. Competitive developers and manufacturers must create a wider variety of formulations at an efficient rate while constantly meeting the high standards enforced by regulators. Their tools, including fill/finish system machines, must accommodate these goals by providing exceptional flexibility and repeatability while adhering to increasing complex regulation.
In drug product manufacturing, it is critically important to adequately treat each patient based on their individual needs. Pediatric populations require special considerations when formulating drug delivery methods.
Dr. Marina Malikova, M.A., PhD, MSci, MA, CCRA, RAC
The ICH GCP E6 revised guideline was issued to reflect on the current research landscape: increase in globalization, studies complexity, and technological capabilities. The updated ICH GCP E6 (R2) Addendum is more descriptive than the previous version and contains 26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risks assessment; monitoring plans defined and implemented; introducing risk-based quality management; serious breaches, and, a new section on computer validation and electronic records, etc. This review will explore the changes to provide a better understanding of how they impact conduct of clinical trials for sponsors, participating sites, CROs and vendors.
Quanticate is offering a range of clinical trial visualizations to allow sponsors to get valuable, real-time insights into their trial data.
Jeff Elliott
To meet stringent regulatory requirements, such as the United States Pharmacopeia (USP), National Formulary (NF) or FDA, as well as production and budgetary demands, pharmaceutical manufacturers require high-volume precision blending of formulations on equipment that provides exceptional batch-to-batch consistency and repeatable results.
Del Williams
Few industries require as much care for precision and security as the pharmaceutical industry. Every part of production and each end result must be made with the utmost accuracy and attention to detail. As measurement requirements become more precise, exceptional accuracy becomes critical because too much or too little of a substance can significantly affect the potency, effectiveness, and overall safety of a drug.
Chris Johnson
Regulation is at the heart of the pharmaceutical industry – and these guidelines aren’t exclusively associated with research and development. Managing contamination is a huge concern for pharmaceutical manufacturing facilities and these sites are usually developed with an intense onus on safety. Here, Chris Johnson, managing director of ceramic bearings supplier SMB Bearings investigates why this stringent approach doesn’t always translate into plant maintenance.
Jiang Li
Technology is unlocking more patient data than ever before, promising more personalized and proactive healthcare delivery. But while consumer health wearables have proliferated, pharmaceutical applications of this technology have lagged. However, the emergence of connected healthcare solutions, such as wearable medical sensors, is changing the landscape.
Chris Komelasky, Gaurav Bhatnagar
Today’s clinical research environment is more competitively challenging, has higher costs and takes longer to bring a drug to market than at any other time in history. According to the 2015 Tufts Center for the Study of Drug Development research, from 2005-2015 the average Phase III study saw an increase in the complexity of protocols, driven by the ever-increasing set of inclusion and exclusion criteria (+61%), number of clinical endpoints (+25%), and number of study visits (+25%) and procedures (+70%), are driving more and more protocol amendments and adding to that cost and time. At the same time, the percentage of patients taking part in clinical studies remains at historically low rates, estimated to be less than five percent of the patient population. This contributes to low and non-enrolling sites, further contributing to the cost and time.
Paul Fioravanti
In the 1990’s, big pharma began the process of selling off their large plants to entrepreneurial companies called Contract Development and Manufacturing Organizations, or, “CDMO’s.”
Pharmaceutical Outsourcing in conjunction with SCORR Marketing recently conducted a survey of pharmaceutical industry professionals to determine how companies select CDMOs and CMOs; how and how often companies outsource, and how they prefer to search for information about CDMOs and CMOs; and to identify any differences between the perspectives of those who work for companies that outsource (pharmaceutical and biopharmaceutical companies) and those who work for CDMOs and CMOs (manufacturers).
Sunny Christian, MS, Neelam Sharma, MS,, Hemant N. Joshi, Ph.D., MBA
This quarterly review of new drug applications contain data for applications approved for the first time during the third quarter of 2019 which includes New Molecular Entities (NMEs) and new biologics. A total of 36 applications were approved by the FDA during these three months.