Robert Dream
The world economies are increasingly threatened by barriers to trade, while the pharmaceutical sector through the International Council for Harmonization (ICH) has been stepping up the effort to dismantle obstacles to global trade in medicines.
Dr. Johannes Kiefer
Raman spectroscopy is an established analytical method in the pharmaceutical industry. Micro-spectroscopic setups utilizing the backscattered signal are common in the analysis of solid samples such as tablets.
Dr. Shaukat Ali, Karl Kolter
Kolliphor® HS 15 is an exceptional solubilizer with attributes suited for parenteral and oral formulation of poorly soluble molecules. As a consequence, it is primarily used in screening of new chemical entities (NCEs) and also used as a vehicle in delivery of molecules encapsulated in micelles or micro-emulsions. Its physicochemical and application relevant characteristics are attributed to a unique structure comprised of 12-hydroxystearic acid (lipophilic moiety) and polyethylene glycol (hydrophilic moiety). As a solubilizer with exceptional safety and toxicity profiles, and regulatory perspectives, it offers unique advantages over many other solubilizers of its class for injectable (IV, infusion, im, sc) formulations, in self-emulsifying drug delivery systems (SEDDS/SMEDDS) and lipid based nanoparticulates.
Tony Cundell, Ph.D.
This review article will discuss the definition of an objectionable microorganism, the prevalence of members of the Burkholderia cepacia complex (BCC) in U.S. product recall and nosocomial infection outbreaks, why BCC members are serious opportunistic pathogens, the screening and identification methods for members of the complex, and how the risk of microbial contamination of non-sterile drug products can be mitigated.
From the time a new, potentially therapeutic substance is discovered to the time it is available to consumers, the clock is ticking. Bio/Pharmaceutical companies need to launch new products as quickly as possible, yet still maintain the highest levels of quality - a quality that is demanded by regulatory agencies and the public.
Kristen Cardinal, Hao Sun, PhD
Artificial intelligence comes from sophisticated computer model based “machine learning” and “deep learning.” Microsoft and IBM provide AI infrastructure using modeling tools. Farmers are able to develop intelligent planting, irrigating and harvesting systems to increase yields to feed the expanding population of our planet.
Having led global quality organizations for many years, I had the opportunity to see first-hand the many challenges of ensuring that employees had the appropriate level of knowledge; and that their knowledge then translated to skills, motivation and commitment to do the right thing when faced with inevitable issues in pharmaceutical manufacturing and analysis.
Alyn McNaughton
It is currently estimated that over 25% of all drug products in development have highly potent or highly toxic active pharmaceutical ingredients (API) and require some form of specialized handling. In oncology this figure is likely closer to 70%.1 These types of products represent a growing sector of investment in the pharmaceutical industry, with the market value from existing and new product launches expected to double between 2018 and 2025.2
A series of disciplines in the field of specialized parenterals including personalized medicine, nucleic acid APIs and gene editing are driving demand for advanced drug delivery technologies. These technologies must not only be safe and efficacious, but simple to customize and efficient to manufacture. Other common formulation challenges include the effective penetration of target cells, and ensuring extended release occurs reliably for either systematic or local delivery over days, weeks or months. Technologies such as lipid nanoparticles (LNPs), which can safely encapsulate the API to protect it against degradation while enhancing biodistribution and solubility characteristics, are well positioned to address such challenges.
Izabela Gierach, PhD, MBA, MS, David Wood, PhD
Reliable, consistent, predictable and cost-effective protein purification platforms, with the smallest possible number of steps, are highly desirable for protein research and manufacturing. This is one of the reasons why intervening protein (intein)-based protein purifications have become a focal point among other intein applications.
Marc Taraban, PhD, Yihua Bruce Yu, PhD, Christopher B. Fox
The filling level, sedimentation, and resuspension of aluminum adjuvants (alum) in sealed vials can be quantitatively assessed in situ using the water proton NMR (wNMR) technology. wNMR demonstrates high sensitivity and high throughput capacity (10-40 sec per vial). wNMR makes it possible to quantify alum filling and suspension in every vial in a batch before product release by vaccine makers and before injection by end-users.
Anvit Vasavada, M.S, Sunny Christian, MS, Amitkumar Lad, PhD, Hemant N. Joshi, PhD, MBA
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in November-December 2018.
Alexei A. Yeliseev, David J. O’Connell
Heptahelical G protein-coupled receptors (GPCR) comprise a large family of integral membrane proteins involved in a wide array of cell signaling pathways. For high resolution structural studies of these receptors, multi-milligram quantities of pure and structurally unperturbed proteins are required. Purification of recombinant GPCRs typically involves their solubilization into detergent micelles followed by chromatographic purification. Because of relatively low expression levels of these recombinant receptors, it is challenging to design an efficient strategy for selective and efficient purification with high yield.
Jeff Odum, CPIP
In testimony given 2013 during a congressional modernization hearing, FDA Director Janet Woodcock clearly outlined the regulatory impetus for the industry’s continued drive to implement continuous manufacturing platforms. She challenged the biomanufacturing organizations to take advantage of advances in process and facility design to help achieve improved manufacturing reliability, increased process robustness, and lowering of manufacturing costs.