Not all areas of the drug development process have been able to be transferred to a single-use platform. One of these areas is protein purification. I recently spoke with Iwan Roberts, chief operating officer and co-founder of Puridify, a company developing bioprocessing technologies for biomolecule manufacturing, about this challenge in the industry and what can be done to overcome it.
Biopharmaceutical manufacturers can suffer significant financial losses as a result of a Mycoplasma contamination in a cell culture. Preventing this, though, is easier said than done. Andy Kelly reveals more about the structure of these troublesome microorganisms and detail a study to determine the link between filtration pressure and Mycoplasma retention rates.
The cost of filtration and separation stages within the production of pharmaceuticals has been increasing along with the increased complexity of final drug products.
By using a structured, analytic approach under simulated process conditions at the experimental stage, it is possible to accurately predict filter performance at cGMP level. Andy Kelly explains more...
When using sensors in a bioprocess, their levels of trueness, precision and accuracy are essential.
This case study explains how Parker Domnick Hunter (a division of Parker Hannifin) helped a pharmaceutical company optimize cell density in cell culture tanks that needed to be converted into fermenters to grow E. coli bacteria.
As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount.
Complex drugs (including biologics) were once considered a black box filled with inexplicable structures and incomprehensible variabilities. However, as Momenta’s Craig Wheeler describes, when it comes to tackling the complexity of biosimilars, it comes down to having the “right lens” to succeed scientifically and commercially.
I consider myself to be a fan of the pharmaceutical industry. This is not simply because I write for a media group that covers the pharma industry. I feel like I was a fan even before taking on my current job. It may have started a few years ago when an ailment of old age (I’m 52) began to inconvenience me and disrupt my sleep. One little white pill taken once per day has now relieved me of that issue. So, while there are many industries that bring happiness and efficiencies into my life, only one of those industries has the potential to save the lives of patients with life threatening illnesses, and ease the suffering of others. That is the pharmaceutical industry.
After a great amount of debate, the parties involved in hammering out biologics exclusivity rules in the Trans-Pacific Partnership (TPP) have finally settled on a deal. However, these final negotiations have garnered the ire of the pharmaceutical industry and nonprofit groups alike. But how will this deal impact generics and biosimilar makers?
There are still many key decisions that the FDA needs to make when it comes to biosimilars. Why should we feel optimistic that Califf is the man to make them?
There is no shortage of research reports in the pharma industry forecasting the potential success or failure of emerging therapeutic markets. However, considering the pharma industry seems to have erupted into a civil war over whether or not the market will be as successful as predicted, it is difficult to get a sense of where the market is actually headed.
The MET ONE 3400 portable air particle counter is designed specifically for ISO14644 cleanroom applications. Organize your routine cleanroom monitoring with embedded location and sample recipe management. The MET ONE 3400 portable air particle counter classification wizard assures compliance during periodic cleanroom certification.
GE Healthcare's portfolio encompasses both upstream and downstream processing and includes solutions for large-scale production as well as tools for process development, Quality by Design, analytical analysis and flexible manufacturing.
The formulation scientists at Cook Pharmica have great experience in a variety of formulations and product presentations. The development team will integrate the biophysical and biochemical characterization of your molecule with the final product format, developing a formulation that will ensure delivery of a stable product to the patient.
Magnosphere™ is a superparamagnetic particle for in vitro diagnostics and bio research applications.
Get the latest information on requirements for product and personnel protection, containment, and environmental safety. Understand the implication of personnel and materials flow on layout, as well as the materials and methods of construction of equipment and facilities, particularly from the perspective of cleanliness, functionality, and maintainability.
ASI is a leader in quick and customized single-use-systems. ASI can partner with you from the early stages of concept and design to the final stages of validations and sterilization. ASI specializes in transfer / purification assemblies used throughout the cell culture process. These assemblies are applicable to upstream buffer / media prep, bioreactors, fermenters, harvest, downstream, separation and purification, final product packaging. ASI offers component options such as disposable steam valves, aseptic connections, manifolds and filter assemblies.
GE Healthcare Life Sciences provides the expertise and tools spanning a wide range of applications from basic research of proteins and cells to large-scale purification of biopharmaceuticals.
World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.
Bioprocess Online is the leading source of technical information and thought leadership for the biotherapeutic community. If you are a bioprocess engineer, scientist, bioprocessing manager, biotechnology producer, consultant, QA/QC, project manager, director, purchaser, marketer, or if you are involved in biopharm supply chain or facilities management, you now have access to a comprehensive Web community delivering the latest updates on the business and scientific information you need to succeed in your industry. From upstream to downstream processing through bioanalysis and biomanufacturing, our goal is to provide readers with the most up-to-date information about the issues, challenges, and news they care about most.
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The relationships and considerations of bead structure, pore structure, surface chemistries and ligand design on affinity resin performance targets.