Shaukat Ali, Karl Kolter, Bernhard Fussnegger
Controlled release (CR) has been a subject of continued interest, and the pharma industry is taking a closer look into release profiles of drugs because of risk factors associated with early release (dose
dumping) before being delivered to intended sites to achieve the desired efficacy, and to overcome toxicity and drug abuse issues.
Shireesh P. Apte, PhD
There are as many mutated or gone awry potential biological targets in hyperproliferative cells as there are steps in the biological processes of cellular respiration, metabolism, apoptosis and glycolysis.
This heterogeneity is the single greatest obstacle to cancer therapy.
James R. Bruno
The development of new drugs is a complex process that requires a multiple of scientific disciplines. As drugs become even more complex, the ability of companies to get products to market has become even more difficult. Today, many potential drugs can fail early during the development process.
Rong-Kun Chang, Andrew L. Chang, William H. Chong
Drug abuse, which is defined as the repeated or sporadic non-medical use of a drug for the positive psychoactive effects it produces, is widespread in the United States. According to the 2011 Vital Signs report from the Center for Disease Control, the legal sale of opioid painkillers has increased by 300% over a decade.
Martina Kopp, Houman Dehghani, Ph.D.
Mycoplasmas represent microorganisms that belong to the class Mollicutes. They are free-living and self-replicating bacteria that are,notable for their small size (0.1µm to 0.3 µm) and lack of a rigid cell wall.1
Due to the small size of their genome, mycoplasmas are dependent on complex media or host cell for metabolites.
Leslie Falco
Once the decision was made to deploy standard work in the QC Microbiology lab, a three day workshop that included members of the team, team leads and managers, and the Operational Excellence team
was scheduled as a kick-off for the implementation. As our team had gone through other lean lab deployments, there were questions about how this would be any different and what standard work really meant.
Szabolcs Fekete, Alain Beck, Davy Guillarme, Ph.D.
There is currently a revolution occurring in the pharmaceutical field. With the quest for more targeted therapies and more clinically efficacious drugs, biopharmaceutical companies are increasing their
efforts to develop more and more biologics.
Alton D. Johnson
Pharmaceutical manufacturing technology has been depicted as outdated and inadequate for optimal quality and control. While the industry remains highly reliant on batch processing, there has been a focused effort to apply six sigma and lean principles to
manufacturing operations. Currently, Quality by Design principles are broadly used across the pharmaceutical industry in product development.
Demand is increasing for oral delivery of biomolecules, such as vaccines, peptides and proteins, especially for the treatment of local gut diseases, including irritable bowel disease (IBD).
There has been a growth in the availability
of portable instrumentation, which has been driven by demand over the past decade or more, and the concomitant advances in optics, electronics and supporting technologies that make this possible.
Krizia M. Karry, Ravendra Singh, Fernando J. Muzzio, Ph.D.
With the advent of more portable spectral nstruments, and in view of the Food and Drug Administration’s (FDA) latest article on its views towards continuous manufacturing, it may be time to focus on using
miniature sensors to enable continuous manufacturing. In continuous pharmaceutical manufacturing, raw materials enter and drug products
exit the process continuously, typically at a nearly steady rate.
Eric S. Langer
Fill and finish operations over the past 25+ years have remained relatively stable in terms of technology, capacity, and competitive environment. However, over the past few years, this important area
has rapidly gained importance as biologics have taken on greater value, and regulators have applied more scrutiny to the quality and safety of these high value, late-stage operations.
Xujin Lu, Christopher A. Zordan
Dissolution testing has been an important tool for decades for assessment of drug release from solid oral dosage forms such as tablets and capsules in pharmaceutical development. The amount of active pharmaceutical ingredient (API) in the solid dosage form
which is dissolved over time under well defined test conditions such as
temperature, composition of dissolution medium and hydrodynamics, results in a bulk concentration profile that provides very useful information for formulation design manufacturing quality control, stability studies, and prediction of in vivo performance.
Guy Tiene, MA
The global pharmaceutical excipients market, a multibillion market, is projected to expand at a healthy pace of 6.7 percent annually in the next five years and reach $8.4 billion by 2019 (Markets and Markets, 2015).