When compared to bacterial contamination, Mycoplasma contamination isn't immediately obvious.

The outcome of any contamination event is the same — the disposal of the contaminated media and decontamination of equipment used in the process — but the…

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 from those of bacteria, or a virus, in a way that…

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 to mitigate risks?

Mycoplasma was first isolated in cell…

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 single-use automation.

Indeed, for many biopharmaceutical manufacturers…

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 single-use assemblies include the creation of process fluid flow…

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 manufacturing operations. 

Yet, there is some confusion as to what the terms…

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 processes are being run in single-use format. End users…

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 between products… these are just some of the consequences of over…

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 and other parts necessary to create an assembly are provided…

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 technology.

Here is Parker's summary of the five…

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 drug products and the potency of the products being produced…