Edward A. Church, Eric Hiser
ISTA Standard 20 Revision 2.0 is a process standard developed by pharma
industry experts. It is a design and qualification process that applies the
Quality-by-Design (QbD) approach. The structure and path to design,
test, verify and independently certify a specific Insulated Shipping
Container (ISC) for use is provided. It sets the minimum requirements
for qualifying insulated shippers and has been proven to develop
shippers which meet regulatory expectations.
Ivelisse Colón, Joseph Medendorp
Quality-by-Design (QbD) is now a well-established and commonly
employed approach to the development and commercialization of
products in the pharmaceutical industry. According to a 2012 survey
conducted by Kourti and Davis1, eleven of the twelve pharmaceutical
companies surveyed indicated they use QbD to some capacity in
the development process.
Jon Denissen, PhD, Peter Wunderli, Ph.D., Moira Elmore, PhD, Erica Golueke
Biotherapeutic medicines generated by living cells or organisms are
larger and more complex than chemically synthesized, small molecule
medicines and feature varied mechanisms of action (MOA). They also
are more prone to heterogeneity, and subtle differences may occur
across product lots, resulting from differences in conditions used in their
production processes, including variables such as differences in cellular
post-translational modification, cell passage and culture, production
and purification.
Jonathan Hughes, Stuart Price
Strategic partnerships have long been a major feature of the pharmaceutical
industry. In-licensing, out-licensing, joint research, and codevelopment
arrangements between and among bio-pharmaceutical
companies, and with academic research institutions, abound. Approximately
33% of drugs in the pipelines of the top ten pharmaceutical
companies were initially developed elsewhere, according to a 2014 WSJ
article by Jonathan D. Rockoff.
Eric S. Langer
The biopharmaceutical manufacturing community
continues to find it difficult to staff key
positions, and is turning instead to outsourcing
to fill the gaps. According to preliminary
results from BioPlan Associates’ 13th Annual
Report and Survey of Biopharmaceutical
Manufacturing, hiring trends continue to
plague the industry, and it is finding relief
by outsourcing some increasingly core
activities. Results from the report indicate
that experienced process development (PD)
expertise is very challenging to find. And
this is leading to an increasing number of
companies looking to outsource their PD
activities.
Sonal Pathak, MS, Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
Twenty-five (65.8%) NDAs were for small molecules while the remaining
13 (34.2%) were for large molecules. Most of the large molecules were
used in the cancer therapy. In this quarter, 18 companies (47.4%)
receiving NDA approvals were large companies and the remaining
20 companies (52.6%) were mid-sized and small companies.
Nigel Walker
All signs point to further healthy growth of
the pharmaceutical contract manufacturing
market in 2016. For the fourth year in a row,
respondents to Nice Insight’s annual survey
of outsourcing-facing pharmaceutical and
biotechnology executives expect spending
on outsourcing to increase over the next five
years. Other results of the survey indicate,
however, that only service providers that
meet specific criteria will be considered for
potential partnerships.