Articles in this Issue
Michael J. Miller, Ph.D.
During the past 20 years, the field of alternative and Rapid
Microbiological Methods (RMMs) has been gaining momentum as
an area of research and application across a number of technology
sectors. Recent advances in rapid technologies have also encouraged
the pharmaceutical and biopharmaceutical industries to validate
and implement RMMs in place of their traditional microbiology
methods within QC/QA laboratories and on the manufacturing floor.
Sonia Bedi, Ph.D., Pavan Balabathula, M.S., Bivash Mandal, M.S., Nivesh Mittal, M.S., Himanshu Bhattacharjee, Ph.D.
In today’s global scenario, where the path forward is clearly the advancement in biotechnology, Near Infrared (NIR) spectroscopy has found special applications. NIR is a fast and effective tool for the understanding of the lyophilization process and evaluation of lyophilized materials. Due to its ability to penetrate glass and plastic containers, NIR spectroscopy demonstrates an excellent non-invasive means to analyze lyophilized materials. Infrared technology can not only be used for moisture determination in lyophilized samples but also for in-process control of drug and excipient stability. The technique has been evaluated as a Process Analytical Technology (PAT) tool in lyophilization of biological materials i.e. proteins, polypeptides and monoclonal antibodies.
Christian Vogt, Alexandra Stärk
Isolators in the pharmaceutical environment are used to produce and test sterile drug products with a minimized risk of microbiological contamination from the surrounding. Isolators realize a separated aseptic core practically free of microorganisms, what offers maximized protection for production and testing.
Yong Xie, Ph.D., Nina Cauchon, Ph.D.
Raman scattering technology has been found to be a very useful tool to aid in the development of well-understood solid dosage forms with appropriate manufacturing controls and storage conditions.
Nicole Stieger, Ph.D., Marique Aucamp, Ph.D, Si-Wei Zhang, Melgardt M. de Villiers, Ph.D.
When drug crystals are heated they undergo changes that can be observed under a microscope. Characteristics that can be analyzed under a microscope include melting point, melting range, crystal nucleation, crystal growth, crystal transformations and more.
Regarding sterile dosage production, the past ten years have seen major advances in a number of areas. This includes cleanroom design and sterile filling equipment.
Brendan Griffin
The well-established successes in combinatorial chemistry and high throughput screening have resulted in the rapid identification of many highly potent lead pharmaceutical compounds with optimized pharmacodynamic properties, but relatively sub-optimal biopharmaceutical characteristics
A. Mark Trotter
Single-Use Disposable Bioprocessing products have gained rapid acceptance by biopharmaceutical manufacturers worldwide. Single-use disposable devices and systems have reduced overall contamination rates, enhanced production throughput efficiency resulting in decreased manufacturing operation and maintenance costs.
Fabrice Gritti
The progress made in the fabrication of new monolithic columns designed for fast and high resolution liquid chromatography is investigated. The speed (permeability) and mass transfer (van Deemter plot) properties of the first generation of monolithic column is compared to those of two new research samples.
Yitzchak Grant, Paul A. Dalby, Ph.D., Paul Matejtschuk, Ph.D.
Biopharmaceutical products are now main players within the pharmaceutical industry. However, many biological and biotech products are inherently labile compared to small molecule APIs and so liquid formulations may not always deliver suitable stability for long shelf life and ease of global distribution. Therefore, the dried state is an attractive option, although the drying process is not without its own challenges. In particular, the stripping of the native water shell from proteins may result in loss of potency and denaturation and so the appropriate choice of lyoprotectant excipients is required.