Embracing pharma’s needs
Commercialising product development in the
pharmaceutical industry is a complex task. After
years
of research, companies need to make sure that
their
products are effective, cause minimal side effects
and are
environmentally friendly in order to be commercially
viable. The
drive to reduce risks associated with pharmaceutical
treatments,
coupled with minimising its carbon footprint are
huge challenges.
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The high value of lyophilised
drugs demands improved process control to
achieve good product quality.
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A silent partner, The Linde Group is a leading
supplier of gases and applications to the pharmaceutical
industry. It has succeeded in developing solutions
that meet the evolving needs of the pharmaceutical
industry in a variety of applications across the
production chain . from R&D to quality control.
Linde's suite of applications targets the manufacturer's
needs, from gas solutions for several applications
to improving the controllability of the lyophilisation
process to yield enhancement through cold processing
knowledge and to state-of-the-art technology that
meets strict environmental regulations.
A key challenge in scaling up pilot processes
is minimising
the side reactions that generate unwanted compounds
that can
form in a commercial operation, but are not seen
in the labscale
process. In these cases, product yield can be
significantly
improved by cooling the reaction to a very low
temperature.
Uniform ice nucleation during lyophilisation
Lyophilisation is an important example of a downstream
process and is critical for stabilising valuable
compounds. The
high value of lyophilised drugs, as well as FDA
initiatives such
as Quality by Design and PAT, demand improved
process
control to achieve good product quality.
Control of the product nucleation temperature
is a critical
issue in lyophilisation and can adversely affect
the product's
uniformity because it can lead to less-than-optimal
freeze-drying
cycles. Linde has developed a novel technology
through a
collaboration with a leading freeze-drying OEM
to address this
ice nucleation step during the lyophilisation
process and it is
applicable to laboratory, pilot and production-scale
freeze dryers.
Yield growth through cold temperature processing
A key challenge in scaling up pilot processes
is minimising side
reactions that generate unwanted compounds, which
can form
in a commercial operation, but are not seen in
the lab-scale
process. In these cases, product yield can be
significantly
improved by cooling the reaction to a very low
temperature.
As drugs become increasingly complex, the demand
for
synthesis and crystallisation at very low temperatures
also grows.
Low temperature cooling of process fluids is both
necessary and
beneficial to achieve a high degree of process
control and stability
that will increase product quality, yield and
selectivity. Linde's
CUMULUSR Fluid Temperature Control system is the
optimal
solution for rapidly bringing the process down
to very low
temperatures. It uses liquid nitrogen as a cooling
medium to
automatically cool process fluids in a highly
controlled manner.
Reduce volatile organic compound emissions
Concerns about greenhouse gases also place pressure
on
pharmaceutical manufacturers to minimise volatile
organic
compounds (VOCs) as these can create health and
environmental
hazards. Linde's CIRRUSR vapour emission
control systems are
a comprehensive approach to minimising the release
of VOC.
The nitrogen-based cryogenic process is chlorofluorocarbonfree
that does not generate wastewater. Furthermore,
there is no
secondary pollution in the form of nitrogen oxides,
acids, gases
and dioxins. The inert nitrogen does not come
into direct
contact with the VOC, which means that the condensed
VOC
and evaporated nitrogen can be recycled and reused
for other
purposes in a customer's process, thus significantly
reducing
operating costs and increasing sustainability.
Cost-effective and adaptable solutions
Customer needs and environmental regulations are
constantly
changing, which means that pharmaceutical companies
require
partners that are swift and can adapt to the industry's
evolving
needs. Linde's solutions are a proven portfolio
of cost-effective
solutions, targeted to meet these demands.
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