Filter qualification typically involves demonstrating bacterial
retention of a filter under process simulated conditions. A crucial
first step in this is in the hands of the filter vendor, who...
On May 15, 2019
The consequences of failure during downstream processing are
severe. Following the Affinity Chromatography stage, the value of
the product increases significantly at every step. A failure at the
On January 17, 2019
Mycoplasma contamination events, although rare, can have an
enormous and immediate negative impact on biomanufacturers leading
to reduced productivity and delays in products
reaching patients. Parker...
On January 7, 2019
One of the challenges faced in any biopharmaceutical process is
bioburden control and containment — or how do you keep what is out,
"out" and what is in "in". For a stainless steel-based
On September 13, 2018
Effective filtration is vital to process protection and factors
such as filter selection, testing and optimization can have an
impact on process risk. Here we examine the factors to consider
On February 13, 2018
In Parker Bioscience’s webinar entitled Protect The Process,
Protect The Patient, the concern that biopharmaceutical
manufacturers have regarding the impact of human error on their
processes was all...
On January 30, 2018
Picture the scene: Unprecedented rainfall and poor flood defences
causes flooding to a biopharmaceutical facility, damaging
equipment, making large areas of a site unsafe and inaccessible,
On December 19, 2017
Plant shutdown, a shortage of key products, patients unable to
access important drugs, profits hit … the consequences of a
biological contamination can be devastating for a...
On August 16, 2017
Ensuring process integrity – which means being able to effectively
test for leaks – is a critical factor in biopharmaceutical
manufacturing processes, especially given the high value placed on
On July 31, 2017
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
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
On May 16, 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
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
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,
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