James Bernstein Ph.D.
A significant trend in the pharmaceutical industry is the increasing
proportion of early drug development carried out in smaller
organizations, as opposed to the large vertically-integrated
pharmaceutical companies. Most of these small organizations use contract
development and manufacturing organizations (CDMO’s) for the Chemistry,
Manufacturing and Controls (CMC) aspects of development. In this model
of drug development, a small innovator organization works in partnership
with contract organizations for the early non-clinical, clinical, and CMC
aspects of drug development.
Laura Brown, Ph.D.
Pharmaceutical companies are facing the increasingly-stressful
challenge of delivering greater performance at less cost and in
less time while complying with a rising number of regulations and
guidelines (such as ICH GCP and the Clinical Trial Directive). This places
tremendous pressure on the technical and managerial skill base of all
companies, large, medium or small.
Dennis Jenke, Ph.D.
During their manufacture, storage and use, pharmaceutical drug
products come into contact with polymeric materials, components
and systems. Although these components and systems are
constructed from materials and by processes that seek to minimize the
extent to which contact can occur, neither truly inert materials and
systems nor truly benign contact conditions exist and interactions which
potentially impact product quality can occur. One such interaction is the
migration of components out of the material and into the pharmaceutical
drug product. Migrating substances are a concern due to their potential
impact on the finished drug product’s suitability for use. For example,
migratory substances could adversely affect the safety and efficacy of the
finished drug product, directly or indirectly. The extent of migration must
be evaluated, and it must be established that the impact of the migration
is within acceptable values.
Matty Toomb, C. Ray Goff, Jr., Kevin Michael Lawler, Martin Peter, Melissa Germain, M.Sc., Jean-Pierre Emond, Ph.D., Jamie Chasteen, Kenneth Lukes, Henry Ames
MT: It seems that when American Thermal Instruments introduced
our cloud-based temperature management system two years
ago, we were the only company that had a flat screen in our tradeshow
booth talking about transmitting data and apps. Now, it does not matter
what the product line is, every supplier is talking about their cloud and the
need to hire software engineers and suppliers to their workforce.
Michael Pohlscheidt, Mahalia Corrales, Salim Charanyia, Eric Fallon, Manfred Bruch, Marco Jenzsch, Christian Sieblist
Since the early 1980s, biotechnology products have shaped the
pharmaceutical industry. A large number of monoclonal antibodies
and therapeutic proteins have been approved and are predicted to
be the major source of revenue in upcoming years for the industry