The priority of speed to market is often at odds with issues around development resources, facility space, and infrastructure for both development and manufacturing. Continuous bioprocessing provides solutions for many of these challenges in certain applications, but to deliver on this promise we need fit-for-purpose tools and technologies to enable process development and provide reliable transfer to commercial manufacturing.

Alan Dickson talks about the evolution of the CHO Cell line from isolation to workhorse of the biomanufacturing industry, to gene edited knockout variants. It is an interesting look at why CHO cells have been so successful and how this success continues to be improved upon for manufacture of emerging therapeutics.

In this podcast, Ratish Krishnan, Associate Director for Cell & Gene Therapy BioProcessing for the Americas at MilliporeSigma about the importance of 3D culture and the challenges associated with growing and maintaining culture in 3D.  We also discussed using a 3D culture bioreactor system, which employs clinostat technology to culture spheroids and organoids in a way that maintains the structure and function of in vivo cells. 

In this podcast, we spoke with Dr. Stephen Fey, Chief Research Officer and Co-founder, CelVivo about the importance of 3D culture and the challenges associated with growing and maintaining culture in 3D.  We also discussed using a 3D culture bioreactor system, which employs clinostat technology to culture spheroids and organoids in a way that maintains the structure and function of in vivo cells.

In this podcast, we conducted a panel discussion with experts from Wuxi Biologics about one of the great technological advancements of the last decade, CRISPR/Cas9 technology. We discussed the technology’s potential and in particular its possibilities in the discovery and development of biopharmaceuticals. We also conducted a deep dive on its potential impact on bioprocessing and biomanufacturing.

In this podcast, we conducted a panel discussion with experts from Peak Proteins on common protein challenges and the use of mass spec to overcome expression and purification issues. We also discussed how mass spec can also be utilized in working with complex proteins and in-process modifications.

In this podcast, we spoke with Dr. Ann Rossi Bilodeau, Senior Bioprocess Applications Scientist and Dr. Catherine Siler, Field Applications Scientist both with Corning Life Sciences, who shared insightful tips for setting up a new lab. We discussed how to create a lab plan, maximize lab space, stay within budget and timelines. They also shared their experience in implementing lab safety and training as part of the new lab launch. Show Notes We began the podcast by talking about how...

In this podcast, we talked with Chris Scanlon, Global Marketing Development Manager at Thermo Fisher Scientific about how to effectively evaluate which FBS product is right for each application. This includes weighing product quality levels and country of origin. Chris also shares strategies for maximizing purchasing options and new FBS products on the horizon. We began the interview by talking about how FBS has evolved to include several different product quality levels to meet the needs...

In this podcast we talked with DQ Wang, PhD, and Vice President, Formulation, Fill and Finish of WuXi Biologics about their DP4 multi-product fill & finish facility featuring the Vanrx SA25 robotic, gloveless, isolator-based filling system. The system significantly reduces drug product fill risk and provides greater aseptic assurance. The facility is the first in China to use this technology platform and the system fits perfectly with “scale-out” manufacturing paradigms.  This...

In this podcast, we talked with Ken Chen, MBA, Senior Director, Regulatory Affairs, WuXi Biologics about staying current with regulatory changes. We discussed how WuXi Biologics recently began publishing a quarterly summary of regulatory updates on new or revised guidance documents from the various global regulatory agencies and how this is a valuable resource for anyone in the biological drug development arena. I began the article by asking Ken what prompted WuXi Biologics to begin...

In this podcast, we interviewed Markus Gershater, Chief Scientific Officer with Synthace about computer aided biology and how it addresses several common biomanufacturing challenges. We also discussed ways to build a common culture between science and software. I began the inteview by asking Mr. Gershater to describe the concept of Bioprocessing 4.0 and what it means to the industry. Markus explained that the term 4.0 refers to the industrial revolutions that have happened throughout...

In this podcast, we talked with Thierry Cournez Vice President, BioReliance® End-to-End Solutions, MilliporeSigma.. We discussed effective ways for emerging biotechs to collect material quickly and cost-effectively for pre-clinical and clinical studies. We also discussed managing the need to move quickly with cost and quality. Show Notes I began the interview by asking Mr. Cournez if he could talk about how MilliporeSigma works with emerging biotechnology companies. He said that...

Cell counting is a challenging technique, with many pitfalls, that can delay entire projects. We talk with Christian Berg about how new technologies are solving these challenges and enabling standardization of cell counting across organizations.

Spheroids can be an improved model for cancer in the lab compared to standard 2D cell culture. When cancer cells are cultured as spheroids, they are able to maintain the shape, polarity, genotype, and heterogeneity observed in vivo (1). This allows researchers to create models that are much more reflective of what’s going on in the body. For a simple example, if you think about drug penetration into a 2D monolayer of cells it’s completely different from drug penetration into a solid tumor. In...

In this podcast, we talked with Dr. Gil Van Bokkelen, Chairman and CEO, Athersys about recent clinical breakthroughs in regenerative medicine and manufacturing challenges. We also discussed Multistem and how it has been demonstrated to help patients with ARDS (Acute Respiratory Distress Syndrome).

In this podcast, we conducted a panel discussion with experts from Selexis and KBI Biopharma on bi-specific antibodies. We examined bi-specific antibody development and manufacturing, including current challenges and key solutions. We also discussed the promise of these cutting-edge therapeutics and their future in medicine.

In this podcast, we talked with Dr. Glenn Harris,  Director of Integrated Life Sciences Platforms at 908 Devices, about the benefits and challenges of implementing rapid media analysis in process development, including the bottleneck created by outsourcing samples to core labs. We also discussed an easy to implement, benchtop media analyzer that permits comprehensive media analysis in real-time, thus speeding process development efforts. I started the interview by asking Glenn if he could...

Dr. Jennifer Chain, Scientific Director of Research and Development, Oklahoma Blood Institute, talks about the isolation of mesenchymal stem cells form cadaveric bone marrow and the differences between live and cadaveric donors

In this podcast, we talked with Dr. Tobias Hertzig, Regulatory Affairs Manager and Dr. Ulrich Tillmann, Global Product Manager, Supplements and Manufacturing Aids both with MilliporeSigma about non-animal origin cell culture media supplements. We discussed the regulatory advantages of non-animal origin, performance vs. animal origin material and the manufacturing process.

Max Blomberg and Andrew Govea talk about the challenges of handling bulk drug substance, specifically freeze and thaw and how the need for scalability, flexibility, and a robust approach led to the development of CryoVault. 

Jonathan Royce details new technologies to monitor critical quality attributes, reduce development time and increase the number of projects that can be run.

Paul Jantzen, Product Manager for IncuCyte at Sartorius talks about the benefits of real-time live-cell analysis and image processing workflows. We also discussed how live-cell analysis is enabling the use of neuronal cell models to study cell health, morphology, function and cell dynamics. 

Dr. Paul Wotton, Chief Executive Officer, Obsidian Therapeutics talks about the evolution of cancer therapy and new advancements in the space including precision medicine. Our discussion included Obsidian's cytoDRiVE™ platform that provides a technology, in which the level and timing of protein activity are fully controlled in a dose-dependent manner by an FDA-approved small molecule.

Shareen Doak and Dr. Wolfgang Moritz talk about the use of 3D cell-based human liver microtissue models to predict the adverse effects of chronic exposure to nanomaterial . We also discussed the use of liver microtissue models for drug discovery and development.

Susana Alcantara, Senior R&D Scientist and Neuroscience Program Leader, BioAnalytics, Sartorius talks about the ways real-time live-cell analysis is enabling neuroscience research.