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.
In a recent report, it was projected that the value of the immunotherapy market is expected to rise from today’s worth of $41 billion in 2015 to $80 billion by 2020. Today’s key trends in the industry will be instrumental in shaping this space and forging a path toward lower costs and increased innovation.
There are many factors a manufacturer should consider when deciding on whether to use stainless steel or single use in their facility. However, before considering any others, experts say this answer is likely to be found by looking at one key piece of information - titer.
This year's BioProcess International Conference & Exhibition in Boston covered a variety of issues spanning across five tracks. However, much buzz followed Wednesday morning's keynotes from experts at Amgen and Genzyme that highlighted two top trends in biomanufacturing: flexible facilities and continuous processing.
At this year’s BioProcess International Conference & Exhibition, David Pollard, executive director of technology development within bioprocess development at Merck & Co. Inc., will present a keynote on what is being done to support the mAb-driven immunotherapy revolution. Specifically, he plans to discuss the need to innovate monoclonal antibody (mAb) production in order to support this effort.
A new conference, Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications, aims to bridge the gap among the different technical teams of experts involved in single-use by looking closely at the science of plastics as it applies to bioprocessing.
If the method used to determine whether or not a protein is a viable target for drug development were improved, pharmaceutical companies could potentially avoid the losses associated with finding out too late that a drug has harmful side effects and/or a lack efficacy. So how can pharma do this? Well, fortunately for them, some new technologies are now available to enhance their ability to select and evaluate safer targets in improved cell systems.
What FDA news did you miss for the week of September 28th to October 2nd?
The future of biomanufacturing focuses on a simpler, cheaper, and more efficient way to make medicine. See how the BioProcess International (BPI) Conference intends to help drive the industry toward this goal.
In 2007, an advisory board to the FDA Commissioner was tasked with assessing whether or not the FDA is equipped to support current and future regulatory needs as they relate to medicine and food. At that time, the committee concluded the FDA did not have the scientific foundation necessary to meet its regulatory responsibilities. A subcommittee released an updated report last week. Eight years later, doubt still remains.