Taking steps to understand and control process variation is crucial
to biopharmaceutical manufacturers. The sentiment behind the old
adage, "the product is the process" can’t be dismissed. ...
On June 6, 2017
Single-use technology plays an integral part in nearly all
bio-production processes, yet several challenges remain —challenges
which are serious enough to delay or even stop the use of
single-use...
On May 24, 2017
Imagine the scenario: Your new blockbuster drug is making a
significant difference to the lives of patients. But then your
supply chain fails, taking the product out of circulation. The
consequences...
On May 16, 2017
Downstream oil and gas operations include refineries and
petrochemical plants where crude oil is processed into finished
products such as jet fuel, diesel, lubricants, and gasoline.
Refineries operate...
On April 20, 2017
Twenty years ago, Professor Bernhard Sonnleitner, of the
Institute of Chemistry and Biological Chemistry at the Zürich
University of Applied Sciences, suggested that the bioprocess
industry would...
On March 9, 2017
The use of automation in running complex single-use systems has
many benefits such as process control and consistency, increased
speed, reduced labour costs and operational flexibility....
On February 7, 2017
Single-use technologies have emerged as a significant and growing
resource in the biopharmaceutical industry but there is still some
trepidation around their use, meaning that some manufacturers
are...
On January 17, 2017
The design space - a toolbox of validated parts and assemblies -
allows an end-user to build any single-use device needed, utilizing
a combination of validated parts. Tubing, filters,
connectors...
On December 13, 2016
Major delays in getting products to market, higher costs generated
by design, testing, and management, increased lead times due to
low-volume production runs and the changeover processes...
On December 7, 2016
Single-use technology (SUT) has been adopted on a global scale
since its introduction 20 years ago and its benefits are
well-recognized. Thousands of single-use products are now in
use and entire...
On November 29, 2016
Given the difficulty of linking the molecular structure of a
complex biopharmaceutical to its efficacy and safety, the industry
must maintain that “the process is the product”. Any change to...
On August 1, 2016
A recent Parker domnick hunter webinar discussed the question "Is
Standardization Possible in a Custom Single-use World?". The
webinar looked at how high levels of customization has led to...
On July 18, 2016
For biomanufacturers, using a structured, analytical approach to
process scale-up will breed confidence and ensure quality.
By adopting robust experimental design, results gleaned
during initial...
On July 7, 2016
Buffers are used throughout the production of pharmaceuticals and
buffer filtration is essential in protecting downstream
chromatography and ultrafiltration equipment, controlling bioburden
throughout...
On May 17, 2016
Filtration is commonly used in biopharmaceutical manufacturing in
order to control bioburden within the production process, and the
appropriate use of prefilters can help to optimize filtration
costs....
On March 3, 2016
Parker domnick hunter is committed to increasing productivity and
customer satisfaction through application-driven new product
development, and collaboration is a highly effective way in which
to...
On March 3, 2016
Imagine the scenario: an insulin production facility is forced to
shut down, or production ceases, limiting the availability of
insulin to diabetics around the world. It’s a disturbing picture
and...
On February 24, 2016
Selection of the appropriate filter product for a given application
in your bioprocess is critical, as an incorrect decision at the
specification stage may have significant economic, quality...
On October 12, 2015
Sterilizing filtration is now commonplace in pharmaceutical
manufacturing and is used in order to prevent microbial
contamination from negatively impacting drug quality and, more
importantly, to...
On September 3, 2015
There is increasing need to manufacture biopharmaceuticals more
efficiently and cost-effectively due to downwards price pressures
caused by trends such as the emergence of the market for
biosimilars....
On August 4, 2015
