Bioprocess Pharmaceutical Filtration

Mycoplasma Contamination - Why So Serious?

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...

Tackling the Source of Mycoplasma Contamination Biopharmaceutical Processes

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...

Listening, Learning and Applying Knowledge in Product Development

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...

Early Adoption Single-Use Technology Can Ensure Successful Process Scale-Up

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 increase the...

Making Connections? Make the Right Choice for Your Single-Use Process

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...

Extractables and Leachables - a Source of Confusion?

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...

A Guide to Biopharmaceutical Filter Qualification

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...

Automating and Enclosing Bulk Fill Operations - the Way Forward?

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 final...

Mycoplasma Contamination: Understanding the Risks and Taking on the Challenges

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...

The Biopharmaceutical Industry's Definition of Integrity

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 manufacturing...

Filtration and Biopharmaceutical Process Protection

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 when...

Protecting Your Bioprocess From the Risk of Human Error

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...

A Guide to Business Continuity Planning for Biomanufacturers

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, and...

Protecting Your Process From Mycoplasma Contamination

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...

Eliminating Leaks and Faults: Single-Use vs Stainless Steel Systems

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...

Automated Single-Use Technology and Its Impact on Quality

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.  ...

Five Critical Challenges in Single-Use Bioprocessing

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...

Process Protection: What Does It Mean to You?

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...

Engineering Managers: Streamline Your Bioprocess With Automation

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...

What's Stopping You From Automating Your Single-Use Process?

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....