Nicolas Fourrier
Mass spectrometry has developed rapidly to
become an important analytical technique.
However, application to the analysis of
biological specimens was at first limited
because the ionization processes could only
be applied to compounds of low molecular
weight, and the instrument interfaces did not
permit easy introduction of biological samples
into the mass spectrometer.
Sonal Pathak, MS, Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
This column summarizes New Drug Applications (NDAs) from May 2015
to July 2015. In this quarter, FDA approved 26 NDAs.
Ashley Hatcher, Jonathan Hughes
The outsourcing of clinical research is a
significant part of the product development
landscape in the biopharmaceutical sector.
According to analysts, the global clinical
research outsourcing (CRO) market was
valued at $28.75 billion in 2014 and is
forecasted to grow to more than $64 billion
by 2020, with nearly 75% of all clinical trials
performed by CROs.
Stuart G. Levy, PhD
Throughout the developmtent lifecycle of a drug, API manufacturing
processes increase in scale and control, as does the level of required
process knowledge. Technology transfer packages that reflect the state
of knowledge and capability of a given API manufacturing process
serve to set the agenda for the next stage of development.
Mike Chace-Ortiz, CEng
Strong forces continue to shape world pharmaceutical markets, most of
which point to continued market share and volume growth for generics.
As global R&D spend stays flat, regulations continue to tighten, user
fees increase and industry consolidation heats up again, how can
manufacturers respond? By analyzing examples of successful industry
growth models, what role can information play in helping companies
transition to higher value products and services quickly and efficiently?
Which sources of information are required to inform these new and
different strategies and meet the changing needs of an industry and
companies undergoing change?
Edward S. Price
While CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is
getting a lot of attention as this year’s potential wonder therapy, the generics
industry continues to undergo change. Positive change.
Guy Tiene, MA
Predictions for healthy growth in demand for biologic drugs are driving
many manufacturers, including branded and biosimilar drug producers
and contract manufacturers, to invest in new production facilities.
These state-of-the-art manufacturing sites often look quite different
from traditional plants, however. Rather than massive, three story tall
permanent stainless steel reactors, biopharmaceutical companies
are opting for much smaller (typically 2000 gallon max) disposable
bioreactors. Many factors are influencing this move to single-use
technologies, not least are the benefits they provide, such as reduced
capital expenditures, reduced risk for cross-contamination, and greater
flexibility to meet changing market needs.