by Nick Hutchinson
Process intensification and continuous biomanufacturing continue to attract a lot of interest within the biopharmaceutical industry as method that can increase productivity and make the most efficient use of production assets.
I interviewed Dr Gerben Zijlstra, formerly of DSM Biologics and the first named inventor on the patent for the XD® (Concentrated Fed-Batch) Technology. He now designs and implements continuous process platforms for biomanufacturers around the world for Sartorius Stedim Biotech.
What is the difference between intensified and continuous bioprocessing?
GZ: A fully continuous biomanufacturing process consists of interconnected continuous unit operations, without intermediate holding tanks, through which the product travels into the containers for Drug Substance in a seemingly constant flow.
Continuous unit operations represent an extremely intensified form of processing and have short downtimes relative to the amount of time they are used for production. A fully continuous biomanufacturing process might have a perfusion bioreactor coupled to a multi-column chromatography capture step, followed by flow-through virus inactivation, multi-column intermediate purification, a flow-through membrane adsorber polishing step, continuous virus filtration and a final ultrafiltration step operated in continuous mode. K.B. Konstantinov and C. Cooney have written an excellent review on this subject.
Continue reading “Continuous or intensified bioprocessing? The gold standard for improved productivity”
With Nick Timmins, VP of Technology and Director of BridGE, CCRM
Nick Timmins, VP of Technology and Director of BridGE at CCRM sat down with us this October at Biotech Week Boston to discuss the collaboration efforts between CCRM and GE Healthcare, what issues have been encountered along the way, his experience working with start-ups, and much more. When initially outlining the GE collaboration, Nick mentions, “A key focus of this collaboration is really about identifying where gaps are in the field for cell and gene therapy manufacturing solutions both on the process side of things as well as the technologies that we utilize to enable those processes.” watch the full interview below to hear his complete thoughts on these pressing issues and the importance of this collaboration on the cell and gene therapy industry.
Jon A Rowley, Ph.D., Chief Executive and Technical Officer at RoosterBio Inc. will be joining the speaking faculty at the upcoming Cell & Gene Therapy Bioprocessing & Commercialization conference taking place October 5-7 in Boston, MA. Dr. Rowley was kind enough to sit down with the Cell & Gene Therapy Bioprocessing & Commercialization team to discuss the important trends that will be shaping the cell therapy industry in the coming years. In this exclusive Q&A, he addresses what he feels are the three major trends setting the stage for a new era of productivity in Cell Therapy.
Continue reading “Q&A with Jon A Rowley, Chief Executive and Technical Officer at RoosterBio Inc.”
We caught up with Dr. Larry Couture, Vice President of the Center for Applied Technology Development, City of Hope, to discuss the challenges facing the regenerative medicine industry, especially during regulatory approval.
Where do you see the biggest challenges facing regenerative medicine developers in the next five years?
LC: The field is really beginning to take off. There are clinical trials and academic trials that are about to enter the clinic or will be entering the clinic in the next couple of years.
One of the problems that is starting to emerge is where this is going to go and what we are going to have to face. Some of the issues we are dealing with right now that I think are going to become big are cost of goods and the ability to scale-up some of the manufacturing processes. Also the purity of the cell product; not necessarily trying to achieve 100% per se, but trying to optimize purity and identify how pure these products should be.
Continue reading “Podcast: What are the biggest challenges facing regenerative medicine developers during regulatory approval?”
In an industry as dependent on cutting-edge technology as bioprocessing, there will inevitably be a huge range of ever-changing challenges facing manufacturers. However, for Parrish M. Galliher, CTO Upstream at Xcellerex at GE Healthcare Life Sciences, one issue currently stands above all others: “The biggest challenge right now is the rate of change of drug design.”
Galliher describes how as drug diversity increases, “so the timescale to respond from a manufacturer’s perspective must by definition shrink…The manufacturer’s tool chest is beginning to be pressed for technologies that afford speed of change and many facilities being built are increasingly at risk of becoming obsolete.”
Continue reading “EXCLUSIVE INTERVIEW: Combatting the Manufacturing Challenges of Increasing Drug Diversity with Parrish M. Galliher, CTO Upstream at Xcellerex at GE Healthcare Life Sciences”
Interview with Daryl Fernandes, the CEO of Ludger Ltd and QbD expert