Four viral vector experts from diverse groups within Pall Corporation’s gene therapy manufacturing organization – Denis Kole, Jon Petrone, Marc Bisschops and Nathan Hazi – join BioInsights to share insights in hot topics for the field, including optimizing upstream process yield and titer, full/empty/partially full capsid separation, and platform process development.
Saadia Zakai and Mark Schofield of Pall join Hélène Lebas of leading viral vector CDMO, Yposkesi, to discuss key current trends and challenges in AAV and lentiviral vector manufacturing, with a particular focus on the cutting edge in lentiviral vector and adeno-associated viral (AAV) vector purification tools.
The tangential flow filtration (TFF) unit operation in viral vector manufacturing is a critical step on the path to commercialization. In this episode, Merck viral vector experts Ratish Krishnan and Akshat Gupta discuss best practices – and common misconceptions – when establishing process conditions and utilizing different TFF device formats.
Professor Dimitrios Mougiakakos is the director of the Hematology and Oncology department at the Otto-von-Guericke University in Magdeburg, Germany. In this episode, he joins us to discuss the exciting potential for CAR T cell therapy for autoimmune disease and how his team has approached GMP manufacturing in the clinical setting. He explains the challenges faced in setting up cell therapy for systemic lupus erythematosus (SLE), and the future of cell and gene therapy in different indications....
Cell and gene therapy scientists are under increasing pressure to achieve results faster and produce cells and cell products more cost-efficiently. Field applications scientists from their major suppliers can provide invaluable support, helping to optimize processes, utilize new platforms and technologies more effectively, and avoid costly errors. In this podcast, three veteran Field Applications Scientists from Corning Life Sciences - Austin Mogen, Catherine Siler, and Chris Suarez - share thei...
Fatema Kazi works for the WHO, where she helps to assess the public health value of vaccine products and technologies in routine, campaign, and outbreak settings. We caught up with her to discuss how innovations in vaccine technology can help get vaccines to the people who need them.
In today’s challenging financial environment, it is more important than ever to get key biotech business decisions right first time. One of the most important and topical of these is the choice of CDMO partner. Dr Kim Watanabe, General Manager and Site Head for Patheon Translational Services, a part of the Thermo Fisher Scientific pharma services contract development and manufacturing organizational arm, joins BioInsights to share her advice and insights into optimizing outsourcing strategy....
Drug development is a costly and time-consuming process associated with a significant attrition rate in the clinic. Safety is an important factor in this, and is a particular issue for cell and gene therapies. A panel moderated by Dr John Maher of King’s College London and Leucid Bio, and featuring Dr Alastair King, Dr Francisca Neethling, and Dr Andrea Bisso, discuss this highly topical barrier to the further clinical and commercial success of the field.
What valuable experiences from first generation cell therapies can the industry carry forward and apply to other indications, such as solid tumors? In this episode, Sean Werner and Chris Brown explore the most important lessons the industry has gleaned from pediatrics, and how they can inform the future of cell therapy manufacturing.
Tom Foti (Vice President and General Manager of the Protein Business Unit, Aldevron) and Dr Kris Saha (Associate Professor of Biomedical Engineering and Medical History and Bioethics, University of Wisconsin-Madison) discuss ongoing work in Dr Saha’s lab to harness different types of HDR templates in order to build cutting-edge systems with the potential to enable point-of-care cell and gene therapy manufacture.
The Maryland Stem Cell Research Fund (MSCRF) is a well-established US state fund aimed specifically at driving the development of new medical strategies for the prevention, diagnosis, treatment and cure of human diseases, injuries, and conditions through human stem cells. Here, we discuss the MSCRF’s specific activities and goals with Executive Director, Dr Amrithar Jaishankar, and get her take on how best to develop collaborative research programs and promote commercialization of stem cell tech...
Transient transfection of plasmids into suspension HEK293 cells is still the most commonly used method for the production of recombinant adeno-associated virus (rAAV) gene therapies – in this episode, Diane Golebiowski and Marissa Stanvick discuss ways to optimize that process.
Welcome to a 2-part series in which we identify and distill some key learnings for partnering success in today's life sciences sector. Perhaps one of the most valuable take-aways from the COVID-19 pandemic response is the sheer scale of what may be achieved through effective collaboration. Over the next three episodes, we'll talk to a range of different stakeholders from across BioInsights' fields of focus, asking them to pass on their tips for what works and what doesn't in this crucial aspect....
PART 1: The Big Pharma Perspective Welcome to a 2-part series in which we identify and distill some key learnings for partnering success in today's life sciences sector. Perhaps one of the most valuable take-aways from the COVID-19 pandemic response is the sheer scale of what may be achieved through effective collaboration. Over the next three episodes, we'll talk to a range of different stakeholders, asking them to pass on their tips for what works and what doesn't in this crucial aspect. In th...
PART 4: Who are tomorrow’s cell and gene therapy workers? Welcome to a 4-part series exploring a question that the entire cell and gene therapy community is struggling with at the moment: “Where will tomorrow’s workforce come from?” The cell and gene therapy field has been advancing at a breakneck speed for the best part of a decade now, fuelled by long-awaited clinical successes, commercial breakthroughs, and a related startling increase in activity from both investors and big pharma. But with ...
PART 3: Innovation in staff sourcing, training and retention - what works and what doesn’t? Welcome to a 4-part series exploring a question that the entire cell and gene therapy community is struggling with at the moment: “Where will tomorrow’s workforce come from?” The cell and gene therapy field has been advancing at a breakneck speed for the best part of a decade now, fuelled by long-awaited clinical successes, commercial breakthroughs, and a related startling increase in activity from both i...
Part 2: How is the educational system responding, and how can the cell and gene therapy community at large help? Welcome to a four-part series exploring a question that the entire cell and gene therapy community is struggling with at the moment: “Where will tomorrow’s workforce come from?” The cell and gene therapy field has been advancing at a breakneck speed for the best part of a decade, fuelled by long-awaited clinical successes, commercial breakthroughs, and a related startling increase in ...
Welcome to a 4-part series exploring a question that the entire cell and gene therapy community is struggling with at the moment: “Where will tomorrow’s workforce come from?” The cell and gene therapy field has been advancing at a breakneck speed for the best part of a decade, fuelled by long-awaited clinical successes, commercial breakthroughs, and a related startling increase in activity from both investors and big pharma. But with this relentless pace of growth and innovation comes the fundam...
Ratish Krishnan and Oliver Rammo share their thoughts on the need for a more nuanced understanding of AAV capture and empty–full separation, and the trends driving innovation in this area.
In this episode Ilaria Scarfone Field Application Specialist, Pharma Analytics, Thermo Fisher Scientific speaks to Mike Brewer, Director and Global Principal Consultant, BioProduction Division, Thermo Fisher Scientific about the challenges for residual DNA testing in viral vector manufacture. To read this interview and access lots more content, visit the Cell and Gene Therapy Insights website....
In this Episode, Roisin McGuigan, Editor at BioInsights, speaks to Dr Barbara Fisher, Process Consultant at Single Use Support about automating aseptic filling for lowest volumes. Barbara works with both established pharmaceutical manufacturers and start-up companies, and has in-depth expedience in low bioburden and aseptic GMP manufacturing from downstream processing to fill and finish. To read this interview and access lots more content, visit the Cell and Gene Therapy Insights website....
