Jessica Kogan, Christopher T. John, Brian Kozlowski
In today’s pharmaceutical environment, a generic, automated sample preparation method is imperative to meeting compressed analytical timelines.
Zai-qing Wen, Ph.D., Guoxiang Chen, Ying Luo, Guiyang Li, Peter Masatani, Pavel Bondarenko, Joseph Phillips, Ph.D., Dr. Xiaolin Cao, Ph.D.
This work focused on the assessment of the capability and suitability of several spectroscopic techniques for detecting adulteration of raw materials used for biopharmaceutical products. Deliberate adulteration of raw materials used in the food and healthcare industry has resulted in a number of adverse events and loss of life. It is now mandatory for biopharmaceutical manufacturers to ensure that raw materials meet the highest quality standards by testing for contamination or economic adulteration with high resolution analytical tools.
Yong Liu, Ph.D., Tim Nowak, Jolanta Plewa, Xiaoyi Gong, Ph.D.
Potentiometric titration is a common laboratory method for quantitative chemical analysis that is routinely used in the pharmaceutical industry.
Dan Klees, Joshua Froimson, Michelle Calhoun, Anurag S. Rathore, Parrish Galliher, William Whitford, Juliette Schick, Ph.D.
One of the emerging trends that we see is in the area of single-use, disposable processing systems. But, “if you can’t measure it, you can’t
control it!”. Magnetrol International is on the leading edge of designing the next generation of disposable, single-use instruments.
Patrick J. Marroum, Ph.D.
The release of the drug substance from the solid dosage form has a major impact on its rate and extent of absorption.
Scott Sutton, Luis Jimenez
An analysis was conducted of 642 microbiologically-related recalls over the years 2004-2011.
Ben J. Boyd, Ph.D.
The performance of functional foods and pharmaceutical products is highly dependent on nano-scale self assembly of lipids and other substances in the gastrointestinal tract.
Sigrid Pieters, Ph.D., Thomas De Beer, Ph.D, Yvan Vander Heyden, Ph.D.
For many biopharmaceutical drug products the last manufacturing step involves freeze-drying. As freeze-drying may be hazardous for the protein’s physical stability, this step can, when not well controlled, transform a product with an acceptable quality into one to be rejected. Knowledge on the protein’s conformational stability during freeze-drying processes is highly desired, as it may facilitate the development of freeze-drying cycles, increase process efficiency and create possibilities for preventing product lost. This paper discusses the suitability of Near-infrared (NIR) and Raman spectroscopy as potential in-line process analyzers for this purpose.
Anthony L. Young
X-ray crystallography has been employed in research and development of small molecules pharmaceuticals for many years. Small molecule active pharmaceutical ingredients (API) and excipients can crystallize as polymorphs which can have different solubilities and stabilities. Changes in solubility and stability can lead to changes in the bioavailability of the molecule [1].
Sheldon F. Oppenheim, Ph.D., Norbert Schuelke, Ph.D.
The harvest process most often used during the primary recovery of cell-based biopharmaceuticals is continuous centrifugation followed by depth filtration. While it is widely used in the industry, little attention is typically paid to this unit operation because of the lack of analytical tools to develop and monitor the performance of this step.
Michael Adler, Ph.D.
Pre-filled syringes (PFS) are well-established, functional container closure systems for biological products. Examples for marketed biological products available as PFS presentation include monoclonal antibody-based products, cytokines and vaccines [1].
Mino R. Caira, Ph.D.
Polymorphs, solvates, inclusion complexes and co-crystals of active pharmaceutical ingredients (APIs) are four established classes of ‘supramolecularly derived’ therapeutic agents.