Eric S. Langer
The embracement of single-use applications by the biopharmaceutical
industry is no secret. They now dominate clinical scale manufacturing,
and as the pipeline of new products advances, are now moving into
mainstream commercial bioproduction. However attitudes differ on which
disposable applications are most important.
Eduardo F. Motti, M.D.
In spite of economic turmoil, flat or decreasing R&D budgets, and public distrust in the pharmaceutical industry, the reasons why clinical trials with new therapeutics must be done remain unchanged, if not stronger.
David P. Elder, Ph.D., Phil Borman
Analytical method transfers are an integral part of the product
lifecycle of medicinal products, particularly as they are moved
between different sites (often not within the same company, i.e.,
outsourcing). There is a requirement under current good manufacturing
practice (cGMP) that methods are suitably validated and verified under
actual conditions of use, which may necessitate suitable validation and
method transfer to the intended site(s) of use [1].
Luc Huybreghts
On March 7, 2013, the revised “Guidelines on Good
Practice for Medicinal Products for Human Use” (2013/C68/01)
were published by the EU authorities [1].
Lori Ball, Amelia Wall Warner, PharmD, RPh, Andrew Brooks, Karen McNamara, Reynaldo Roman
The rapidly accelerating transition from traditional drug discovery
and development to personalized medicine is pushing researchers to
understand more about their samples and to deploy them in novel ways.
High-quality research samples with appropriate clinical annotations
and their respective data are critical components to the discovery of
personalized medicines. In order to support this research, biospecimen
resources need to be developed and managed under established scientific,
technical, business and ethical/legal standards.
Max S. Lazar, Brian Swierenga
Active Pharmaceutical Ingredient manufacturers have faced
their share of regulatory concerns over the years. In fact, the
adoption of the ICH Q7A API GMP Guidance would have never occurred
if not for the absence of an accepted API GMP globally. In my opinion,
the following example was one of the most serious regulatory issues that
U.S. firms had to address with their customers in the European Union (EU).
Yi Qun Xiao, Ph.D., Andreea Halford MBA, MS
When a company outsources macromolecule bioanalysis, the
expectation of their CRO largely depends on the company’s
setting. If the outsourcing request is from a virtual company
without laboratory space or hands-on expertise in bioanalytical
development, the CRO is expected to provide both consulting
and mentoring with suggestions and guidance on study
design, critical reagent procurement or creation, bioanalytical
method development, and spearheading the progress towards
method validation and sample analysis.
May Wattie Singh, Craig Embleton
Drug pooling takes time and expertise
to set up, but when implemented
correctly, it can substantially reduce
costs and increase efficiency