Pete Belden
Cell and gene therapies create the opportunity to significantly transform how diseases are treated and cured. By replacing, manipulating or engineering cells and/or genetic material to fight disease, advances in this field offer a wellspring of hope for enhanced patient outcomes and a new era for medicine.
Tim Sandle, PhD
Biofilms are problematic to pharmaceutical water systems. If a biofilm develops then an out-of-control situation is likely to emerge.
Frédéric Massé, Marie Parat, Allan Matte, Louise Thauvette, Geneviève Hélie, Yves Durocher, Freya Vercauteren
Purification of candidate proteins from a large number of biopharmaceutical samples is a key activity in early-stage discovery programs.
David P. Elder, Ph.D, Patrick J. Crowley
The third and final article in this series deals with the many external challenges that face formulators who are developing preservation systems for multi-use oral, topical and parenteral medicinal products.
Michael D. Hooven
Biologic drugs have been called the driving force in pharma for good reason. They comprise more than half of drugs in development, and they have the potential to address many chronic diseases and various unmet medical needs.
Michael Morgen, Deanna Mudie, Craig Sather, Kimberly Shepard
An increasingly large fraction of drug molecules in development are poorly water soluble. A number of solubilized formulation technologies have been developed and applied to achieve adequate oral absorption of such compounds.
Jamie Clayton
Powders are widely acknowledged as being particularly challenging and unpredictable. For example, they may not flow consistently through the different stages of a manufacturing process and certain blends may be more prone to attrition or segregation.
In this contract laboratory survey conducted by American Pharmaceutical Review, customers of contract laboratories provided feedback on their outsourcing needs and drivers, as well as their experience working with the top ten leading contract laboratories in key areas.
Johannes Kiefer, Ph.D.
Infrared spectroscopy is a common analytical method in the pharmaceutical industry.
Solubilization is a process to solvate the molecule so it dissolves and remains in solution for an extended period without nucleation or precipitation, and becomes available for absorption in the gastrointestinal (GI) tract to improve its therapeutic efficacy.
Mark Copley
The recent introduction of US Pharmacopoeia Chapter <1602> highlights the need to routinely test metered dose inhalers using methods that more closely reflect patient use scenarios.
Paul Kippax
Complex generics are of significant commercial interest. Defined by the FDA as products having complexity associated with an APIs, formulation process, route of delivery, or drug-device combination, they are particularly challenging
to replicate.
NIR spectroscopy is predominantly a way to measure molecular vibrational overtone bands and is widely used in the pharmaceutical industry as a rapid method to ensure a product or ingredient is what it is supposed to be.
Hibreniguss Terefe, PhD, Isaac Ghebre-Sellassie
Advances in pain control therapies over the last decade have led to the discovery of breakthrough drug products that provide patients with a wider range of highly effective medications.
Lander Foquet
Advances in pain control therapies over the last decade have led to the discovery of breakthrough drug products that provide patients with a wider range of highly effective medications.
Anahita D. Eckard, PhD, Nan Liu, PhD, Baburaj Kunnummal, PhD, Rowan Moore, PhD, Peter A. Bell, PhD, Karen Salomon, PhD, Mike Brewer, PhD
N-linked glycosylation is one of the CQAs for biotherapeutics impacting the safety and activity of drug products as well as being indicative of the consistency in production process.
The biopharmaceutical market has seen incredible
growth. In your opinion, what are the drivers for
this growth? Do you see a similar expansion once
biosimilars become more prevalent?
Nigel Walker
The excipient market is enjoying a growth period. According to market and trend analysis firm Grand View Research, demand for stabilizers anti-adherents, bulk fillers/diluents, lubricants, disintegrants, binders, coatings, polymers and other performance-enhancing ingredients is projected at 744,621 tons by 2020.
Anvit Vasavada, M.S, Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, PhD, MBA
When high-dose solid preparations are prepared as a single unit tablet, they are large in size and if prepared as a powder or a granule, they becomes bulky due to low density, making it difficult for children and aged people to swallow.
The quality of the chemical ingredients, APIs and excipients that make up a pharmaceutical product is of primary importance to the overall success of any pharmaceutical drug.
Robert F. Carney, MS, Richard Gill Jr., PhD, Zsuzsa Lakos, John L. Snyder, David Zuluaga, MS
The term “biosimilars,” which is widely used in the biopharmaceutical industry, refers to a generic version of a therapeutic protein.