Mycoplasma contamination poses a serious threat to
biopharmaceutical manufacturers. But it's the specific
characteristics of Mycoplasma that make it such a challenge.
Mycoplasma characteristics differ...
On February 11, 2020
Mycoplasma contamination can have a devastating effect on drug
manufacturers but what are the factors make a bioprocess vulnerable
to Mycoplasma contamination and what measures can be put in place
On February 4, 2020
Although bulk filtration of a product prior to shipping was one of
the first bioprocessing steps to benefit from single-use
technology, it has been one of the last to benefit from...
On November 21, 2019
Whether you are running a process in a 30,000 L bioreactor in
fed-batch mode, a 200 L continuous process, or have scaled-out
(rather than up), you will start at small scale and look to
On October 30, 2019
Single-use solutions have been widely adopted on a global scale
within the biopharmaceutical industry due to the many advantages
and process improvements they offer. Key applications for
On October 15, 2019
In the biopharmaceutical industry, extractables and leachables have
come under the spotlight as stainless steel manufacturing systems
have given way to single-use assemblies in...
On October 7, 2019
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