Terrence Walsh, Donald C. Singer
Responsibility in a contractual agreement between two pharmaceutical
companies has been indicated as one of the common cGMP (current
Good Manufacturing Practices) compliance challenges during this
last decade. Yet, the real challenge is much broader and usually more
basic than cGMP compliance. This challenge is raised to a high level
of risk when selecting and developing collaboration for manufacturing a
sterile pharmaceutical product.
Christine Pierre
Partnering among stakeholders has emerged as an essential tactic
for improving operational efficiency in the clinical trials sector.
Driven by escalating clinical trial timelines, more complex
protocols, stalled patient enrollment, and rising costs, this global industry
is evolving past traditional outsourcing toward various types of strategic
partnerships and collaborations.
Verena Brenner, Dr. Michael Hülsmann
The phenomenon of supply chain disruptions in globalized
production and distribution networks has raised many concerns
during the last years. In general, such disruptions are understood
as unexpected temporal events, which lead to a negative deviation
of the process plans [1, 2]. However, disruptions do not only lead to
immediate losses of e.g. products, but may also lead to considerable
reputation losses [3]. Especially pharmaceutical supply chains, but also
food chains experience a high susceptibility to disruptions, due to the
special nature of the products.
Dennis Jenke, Ph.D.
As previously published in Part 1 of this series: “Collection,
interpretation, and utilization of extractables or leachables (E&L)
data are not trivial processes and the scientific and practical
requirements for performing these activities may extend beyond the
technical and/or resource capacities of many organizations that are
required to possess such data. To bridge these knowledge and resource
gaps, organizations turn to contract research organizations (CROs) to
provide the needed expertise, the needed capacity, or both.” [1]
David P. Elder, Ph.D., David J. Snodin, Ph.D.
This third article in a series on genotoxic/mutagenic impurities (GTIs)
will discuss the challenges facing synthetic and analytical chemists
as they endeavor to identify and ultimately control levels of these
GTIs or PGIs (potentially genotoxic impurities) in drug substance and
drug products. GTIs are residual reagents, intermediates, degradation
products or by-products of synthesis that have a demonstrated ability
to damage DNA, thus having the potential to cause a mutagenic and
possibly a carcinogenic response [1]. GTIs are typically electrophilic
(e.g. alkyl halides, alkyl sulfonates, epoxides [2]), or can be metabolized
to an electrophilic moiety (e.g. aromatic amines, hydrazines [3]) and
act predominantly by alkylation of DNA bases. PGIs are compounds
containing an alerting structural motif; moieties such as hydrazine,
epoxide, aziridine and N-nitrosamine confer a high likelihood of
mutagenic activity, whereas others (e.g. N-oxide, carbamate, Michael
acceptor, carboxylic acid chloride, methylol) are considered to be either
false positives or extremely weak alerts [4].
The rationale in opening a commercial packaging
facility in the US was two-fold. One – demand from our US
clients for a flexible, quality-driven commercial packaging
partner and two – the Audubon site was readily available.
Almac have owned the site in Audubon, PA since 1997.
Originally the facility provided contract clinical packaging
services that relocated to Almac’s North American
Headquarters in Souderton, PA at the beginning of 2011.
Scott M. Wheelwright, Ph.D.
All of us who work in pharmaceuticals in Europe and the US recognize the need for our manufacturing
operations to meet compliance requirements. Quality levels that meet or exceed the expectations of
our regulators are a given for our operations.