N. T. Gilles, E. Marty, D. Roesti, A. Staerk, M. Goverde
In December 2014 the new chapter <1115> of the U.S. Pharmacopeial Convention came into effect. The new chapter deals with microbiological contamination risk control for nonsterile product manufacturing.
Cheryl Platco, Tony Cundell, Ph.D.
A lack of data integrity often is “just fraud,” says Howard Sklamberg, FDA deputy commissioner for global regulatory operations and policy.
Michael Grass, PhD
Bioavailability enhancing (BAE) technologies for oral drug delivery may be designed to overcome many different hurdles to absorption.
David P. Elder, Patrick J. Crowley
The second article in this series deals with the many constraints that
face the pharmaceutical scientist tasked with developing preservation
systems for multi-use oral, topical and parenteral medicinal products.
The key role that pH plays in antimicrobial efficacy, as well as general
stability considerations (both chemical and physical), will be covered.
Girish Malhotra, PE
Use of “Fake and/or False” in our vocabulary has become very pervasive since 2016. I thought it would be useful and helpful to re-visit the definitions of batch and continuous production processes and try to see if either of them fit in the realm of False or Fake “B or C” process.
Samantha Kecman, Victor Dellisola, Stephen Raso
Even with an ever-increasing array of cutting edge technologies at its disposal, the process of drug discovery continues to be a difficult one.
Márcio B. Machado, Suzanne M. Kresta
Mixing is a crucial step in many chemical processes. Poor mixing
can limit the efficiency of an industrial process or cause severe
complications in scale-up. Despite its importance, the replication
of mixing conditions at different scales still needs to be better
understood.
Sidney Backstrom, Peter Makowenskyj, Maik Jornitz
Articles like these generally have the same opening – a discussion
of increasing expression rates in mammalian cell culture systems,
the advent of single use technology, advances in personalized and
orphan therapies, etc. and how they all either by themselves or in
combination with each other have made smaller scale manufacturing
of pharmaceuticals and biopharmaceuticals a growing trend.
Stefan R. Schmidt
Over the last decades drug development expertise for biologicals has constantly increased.
Johannes Kiefer, Ph.D.
Polarization-resolved Raman spectroscopy has great potential as a
means of process analytical technology in pharmaceutical applications.
Recent progress has even enabled enantioselective measurements,
which were previously believed to be impossible. The present article
compares experimental approaches to polarization-resolved Raman
spectroscopy and discusses them with regards to their pros and cons.
Ying Wang, Anil Vasudevan
Over the last decade, there has been an increased awareness on
kinetic and thermodynamic profiling of ligand-protein interactions
and its linkage to the clinical effectiveness of drug candidates. Herein
we provide an overview on where the pharmaceutical industry stands
with kinetic and thermodynamic profiling in drug discovery. We also
discuss the challenges for current technologies as well as provide our
views on future prospects to use kinetic and thermodynamic profiling
for prospective drug design.
Eric S. Langer
Biopharmaceutical manufacturing directly supports the $240 billion biologics industry, and small improvements in costs of manufacturing can result in very significant savings. However, unlike other industries, where adoption of new technologies are often quickly embraced, in bioprocessing, change evolves slowly. This is due to a few factors, but one of the largest is the intense regulation of the industry.
Alan Sheppard
The generic medicine industry has generated significant cost savings for payers over many years (over 100 billion euros in Europe alone in 2014) and provided access to affordable medicines for millions of patients. Competition has been generated through the availability of generic medicines from multiple sources delivering lower prices and a choice of suppliers. One aspect of such competition is that in order to maintain growth a generic portfolio has to be replenished or refreshed frequently.
Biosimilars, unlike traditional generics, require a strong valueproposition and patient support programs to drive payercoverage and provider uptake. Experience, resources and a keenunderstanding of today’s market dynamics are required to advancea promising yet complex molecule into an accessible therapy forpatients.
Nigel Walker
CROs are consolidating to deliver key discovery and early stage
efficiencies in the lab, as well as expert clinical stage trial services, to
accelerate drug development.
What are some current critical industry issues that have made drug delivery such a hot topic? Yihong Qiu, Ph.D., Sr. Research Fellow, Drug Products, Operations Science and Technology, AbbVie: Poor water solubility continues
to be one of the major challenges facing the industry in terms of oral drug delivery. Up to 90% of current candidates from the discovery small molecule pipeline across many therapeutic areas, such as oncology, infectious or rare diseases, are having solubility/dissolution problems. Many of these compounds are extremely insoluble. Twenty to 30 years ago, we thought of poorly soluble compounds in terms of 100 µg/mL, and today we are working on a few µg/mL or even ng/mL solubility.
Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
The purpose of this column is to highlight
and summarize recent key patents in the
pharmaceutical arena issued by the US
Patent Office in July-August, 2017.