In my two previous essays in this series on Single Use technologies published over the past ten months in American Pharmaceutical Review, I described the following regarding the use of single use systems in bio-pharmaceutical drug production: In the first essay, I showed the unexpected yet significant environmental footprint advantage of these single use systems compared with traditional stainless steel systems (1).
John Duguid
Implementing a rapid test method to replace currently accepted methodology for mycoplasma detection requires overcoming unique validation challenges specific to these organisms. Rapid
microbiological methods (RMM) designed to detect bacteria and fungi are challenging to validate as replacements for compendial methods in general. As a result, using RMM to release finished drugs, biologics, and medical devices is relatively rare even though regulators encourage adopting these methods.
Brent L. Kleintop, Qinggang Wang, Ph.D.
High performance liquid chromatography (HPLC) is probably the most widely used analytical technique in the pharmaceutical industry for characterizing new drug substances and drug products. In recent years, the use of very high pressure liquid chromatography (VHPLC) using columns packed with sub-2 micron particles to improve chromatographic efficiency has seen increased utilization for pharmaceutical development applications to provide faster separations without significantly compromising chromatographic efficiency[1-5].
Christoph Saal, Ph.D.
Over recent decades, solubility has become one of the key parameters in pharmaceutical research and development as it represents a key prerequisite for ensuring adequate bioavailability of a compound [1, 2, 3, 4].
Zai-qing Wen, Ph.D., Dr. Xiaolin Cao, Ph.D., Joseph Phillips, Ph.D.
Raman spectroscopy and Raman microscopy are powerful techniques for solid-state in situ protein pharmaceutical analysis within glass containers or for isolated samples. The laser beam of a confocal Raman microscope can be focused sharply on extremely small particles to obtain high quality Raman spectra. The penetration of visible laser light through glass enables in-situ analysis to be performed without any sample manipulation.
Claudio Denoya, Ph.D., Edwin Dawson, Darwin Sessoms, Michael Baumstein, John Shabushnig, Ph.D.
Classical microbiology techniques used in the quality control (QC) of food, cosmetics and pharmaceutical products as well as those used to monitor manufacturing environments are based on the growth of the potential microbial contaminants in liquid or solid nutrient media.
Zhigang Sun, Ph.D., Naiqi Ya, Ph.D., Richard C. Adams, Florence S. Fang
In the pharmaceutical industry, particle characterization of powder materials has become one of the crucial aspects in drug product development and quality control of solid oral dosage forms.
Jun Chen, Ph.D., Gregory J. Gervasio, Patrick N. Ng, James W. Rydzak, Alireza S. Kord, Ph.D.
There are multiple benefits to implementing process analytical technology (PAT) in active pharmaceutical ingredient (API) development and manufacturing. In the developmental stage, PAT is an ideal tool for in-depth process understanding to aid in the design of a robust process. During commercial API manufacture, the benefits of PAT shift to real time assurance (RTA), which ensures consistent product quality, thus eliminating the need for off-line testing and minimizing out-of-specification batches. The intent of this article is to show how PAT can be used to improve process understanding in the developmental stage as well as a tool for real time assurance in the manufacturing.
Dr. Chris Moreton, Ph.D.
In this paper, I plan to discuss excipients and Quality-by-Design (QbD) in the context of the manufacture of pharmaceutical products using continuous processing. Continuous processing is not new; it has been around for many decades. It is just that the pharmaceutical industry has been even more reluctant to consider it than they have QbD. (QbD has only been around as a concept since the mid 1980s [1]; continuous processing has been around for a lot longer.) The reasons for this slowness to adopt new technologies and concepts in general are worth exploring because, in my opinion, they may provide some understanding of how long it could take for QbD to become generally accepted. (But hopefully it will be much quicker because continuous processing can bring real benefits to the pharmaceutical industry.)
Shuxia Zhou, Lavinia Lewis, Ph.D., Satish K. Singh, Ph.D.
Pharmaceutical companies invest significant resources to identify, quantify, and minimize impurities in their drug products. An area of increasing concern and scrutiny from regulatory authorities is the potential adulteration by compounds that may migrate into the drug product through contact with components and materials used in manufacturing, storage, and delivery of the therapeutic. These compounds have been typically referred to as extractables and leachables.
Saeed A. Qureshi
Dissolution tests are employed to establish drug release characteristics of solid oral products, such as tablets and capsules. In reality, dissolution testing may be considered as an extraction technique such as a Soxhlet extractor for extracting compounds from their matrixes or perhaps a simple shake-flask technique for solubility determination. It is not to say that dissolution apparatuses may be replaced or substituted by apparatuses for the two types of techniques mentioned, but highlighting the fact that these all work on the same principle but with different objectives.