Platinum Sponsor
PALL Corporation
Drawing on nearly 70 years of experience supporting cGMP manufacturing of vaccines and protein-based therapeutics, Pall Biotech’s innovative cell therapy platform is designed to help our customers overcome the challenges associated with the production of live cells for therapies. Pall Biotech is dedicated to helping our customers achieve their cell therapy commercialization goals.
Associated Experts
Job Title: R&D Bioprocessing Team Leader
Job Title: Global Product Manager
Job Title: Bioprocess Specialist
Job Title: Global Product Manager
Job Title: Senior Global Marketing Manager, Cell & Gene Therapy
Job Title: Marketing Applications Manager,
Job Title: Director, Accelerator Process Development Services
Job Title: Director, Global Analytics, Biotechnology, Analytics & Controls
Job Title: Biopurification Specialist
Job Title: Head of EMEA Bioprocess Services
Job Title: Research Scientist
Job Title: Manager SLS Purification Consultants Europe
Job Title: Director of Cell Culture Technologies
Job Title: Global Product Manager for the Mixing portfolio
Job Title: Vice President and General Manager, Single-Use Technologies
Job Title: Senior R&D Manager
Job Title: Business Development Manager
Job Title: Senior Vice President, R&D, Biotech,
Job Title: Global Product Manager Depth Filtration
Job Title: Group Leader, Product Management – Biotech Division
Associated Content
New online Gene Therapy Academy offers great resources to support scaling up from lab to production scale
In this podcast, we spoke with Emanuel Krobath, Biopurification Specialist and Chiara Pacini, Bioprocess Specialist both with Pall Corporation about gene therapy process development including challenges and resources that are available for support. I began the ... Continued
Flexible single-use mixers are key to achieving a next level mixing experience and reducing delivery lead times
In this podcast we spoke with Klaus Kienle, Global Product Manager for the Mixing portfolio at Pall Corporation about the latest mixing technologies including single-use solutions, the need for increased flexibility, and a more standard ... Continued
Manufacturing high concentration mAbs challenges and solutions
In this podcast, we spoke to Tom Watson, Group Leader, Product Management – Biotech Division, Gregor Kalinowski, Manager SLS Purification Consultants Europe, and Aude Iwaniec, R&D Bioprocessing Team Leader, all from Pall Corporation, about why ... Continued
GMP manufacturing of mRNA lipid nanoparticles – Challenges and Opportunities
The rapid onset of the COVID-19 pandemic challenged the global scientific community to find a way to combat the SARS-CoV-2 virus. Emerging from relative obscurity, the messenger RNA (mRNA) and lipid nanoparticles (LNP) technologies were ... Continued
Scalable AAV Production Platform from Bench to Commercial Manufacturing
Gene therapies treat disease at a molecular level by transmitting genetic information to a target cell to correct a genetic defect, to inhibit the expression defective gene, to restore normal function or to impart a ... Continued
Optimizing Process Development Early – A critical factor in successful viral vector scale up and large scale manufacture
In this podcast, I spoke with John Ketz and Denis Kole about viral vector production, including current manufacturing challenges, navigating the road to commercialization, and successful scale up strategies. We began the interview by discussing ... Continued
Using End-to-End Integrated Solutions to meet the High Demand for Viral Vector GMP Manufacturing
In this podcast, I spoke with Hanna Lesch Ph.D., Chief Technology Officer at Exothera about viral vector manufacturing. We discussed current industry needs and challenges, scalability, end to end solutions, and key insights to a ... Continued
Increasing Single-Use Technology Operator Competency with New Training Methods
The implementation of single-use technologies (SUT) for biopharmaceutical manufacturing has increased dramatically in recent years owing to their numerous benefits. This has also been spurred by collaboration between end-users and SUT vendors to better understand ... Continued
Scaling up Lentiviral Production from iCELLis® Nano Bioreactor to the iCELLis 500+ Bioreactor
lentivirus production is easily scaled from the bench-scale iCELLis Nano bioreactor to the large-scale iCELLis 500+ bioreactor with very little development work required....Continued
A Demonstration of Effective Scalability of Suspension Cells for the Production of rAAV Viral Vectors using the Allegro™ STR bioreactor System
Reliable and scalable viral vector manufacturing platforms are needed to accommodate the increased demand as more gene therapy treatments are brought to market. These transformative medicines can be used to replace a defective gene with ... Continued
Biopharma Solutions – What we can Learn from the Pandemic
Separated into six parts, the e-book takes a look at the COVID-19 vaccine development and how the pandemic has re-shaped the biopharma manufacturing industry from the perspective of experts within Pall, across a number of areas of expertise....Continued
Integrated Freezing Solutions to Minimize Risk and Preserve Product Quality
Claire Jarmey-Swan, Global Product Manager, Pall Corporation talks about the evolution freeze thaw technologies and how these new methods can streamline the process, minimize loss and maintain the highest product quality....Continued
Sterile Connections – A Critical Part of Fluid Transfer in Viral Vaccine Production
The Kleenpak Presto sterile connector brings enhanced levels of quality assurance with 100% inspection at point of manufacture that allows device traceability, as each device has its own serial number. The manufacturing process employs an automatic vision system that ensures the absence of defects in the membrane and membrane welding...Continued
Securing Sustainable Reimbursement for Innovative Gene Therapies
The insights into reimbursement of gene therapies presented in this article explore challenges and potential solutions based on the U.S. healthcare landscape. While not directly applicable to other nations, risks and solutions identified here may be a starting point for exploration of short and long-term sustainability discussions for other countries....Continued
Evolution of Viral Vector Analytics for Gene Therapy Manufacturing
We spoke with industry experts to get their insight on how the landscape of analytical tools has evolved over the past few years as the implementation of process analytical technology (PAT) by viral vector manufacturers has become more commonplace. Analytical processes have matured and become more refined, but there is still much more that can be improved. It is critical to evaluate as an industry how best to move forward to fill any existing knowledge gaps, whether it is learning from other, more mature bioproduction systems or investing in novel, innovative technologies....Continued
Upstream Manufacturing of Gene Therapy Viral Vectors
There has been a continued shift to the use of fixed bed bioreactors over conventional flatware culture for adherent cells. Fixed bed bioreactors, such as the iCELLis bioreactor, provide a route to increased scale of production up to 500L and a quicker route to market.39 Their use has been enabling for the industry as they can and move production away from an unmanageable number of flatware vessels into a single bioreactor.
There are also advancements in medium scale transfection methods up to 60-70L. There is greater understanding of the large-scale transfection process as gentle mixing and delivering DNA rapidly to the cell within a few minutes are critical parameters.39 New pump and mixing technology has allowed transfection at some increased scale, without a loss of productivity.39 Challenges remain for larger multi-hundred liter scale.
In summary, we see continued advancement and growth in an emerging industry that now has several approved therapeutics on the market and a bright future....Continued
Stay current on the latest industry developments while COVID-19 has us all stuck in place
Pre-COVID our lives were full of in-person trainings, seminars and industry conferences. Now, ten months into the pandemic with travel and in-person meetings eliminated or severely reduced, we are all looking to find ways to ... Continued
A Remarkable Year for Gene Therapies
Amid a chaotic year in many areas, 2020 has been an eventful year for gene therapies—a lot of progress coupled with some setbacks. Notable events so far this year have included a new gene therapy approval, finalization of FDA guidances, FDA striving to manage an increasing number of applications, a widely expected approval not granted, and a trial halted due to patient deaths....Continued
Insights on Successful Gene Therapy Manufacturing and Commercialization
Gene therapies have come a long way since that first clinical study in 1989 and looking forward gene therapies have tremendous potential to deliver on the designation - the future of medicine....Continued
Flexible Platform Solutions Overcome Vaccine Production Challenges
The team from Pall Biotech explores the challenges of vaccine development and how they can be overcome by applying a quality by design (QbD) platform approach from early process development phases forward....Continued
Novel single-use valve design increases efficiency and decreases risk of contamination
There are many challenges facing biopharmaceutical companies during commercial manufacturing. These challenges drive continual improvements in both manufacturing strategy and the associated tools or technologies used. For instance, pricing pressure has increased the need to ... Continued
Integrating bioprocessing steps to improve efficiency and reduce cost
In this podcast, we interviewed Dr. Rick Morris, Senior Vice President, R&D, Biotech, Pall Life Sciences, about integrating bioprocessing steps to improve efficiency, reduce cost and address current challenges in the industry. Specifically we looked at how upstream and downstream can be more integrated and how to increase integration in existing facilities....Continued
Scalable Viral Vector Upstream Process for AAV Gene Therapy Manufacturing
Gene therapy is an exciting area of medicine that has the potential to treat a wide range of diseases for which no other treatments are available. One of the key components of successful gene therapy ... Continued
Cell Harvesting Technologies – Which is best for your process?
Cell harvesting is a critical step in connecting upstream monoclonal antibody production with downstream purification. Selecting the best cell harvesting technology based on the characteristics of the cell culture process can be challenging. This decision ... Continued
Large Scale Adenovirus Production for Gene Therapy Manufacturing
Gene therapy is one of the most promising developments in medicine. It has the potential to treat many diseases by using a gene-modifying technology to repair, replace or correct genetic damage in the body. Last ... Continued
Upstream Manufacturing of Gene Therapy Viral Vectors
Overview The majority of gene therapy applications in development utilize viral vectors to carry the therapeutic gene into the target cells. Cells may be genetically modified either in vivo or ex vivo. In the ex vivo applications cells are modified in ... Continued
Shape Matters – An Innovative Design for Single-use Bioreactors
Pall recently traded the traditional geometry for the cube shape Allegro™ STR single-use bioreactor line. Their innovative cube shape offers unique features not possible in a cylindrical design....Continued
A Look at the Current State of Continuous Bioprocessing
Introduction Recently, BioProcess International in conjunction with Pall Life Sciences published an informative supplement titled, “Is Continuous Bioprocessing the Future? ”. The publication contains 12 articles covering various aspects of continuous bioprocessing as well as additional ... Continued
Pall AcroPrep™ Advance 96-well Long Tip Filter Plate Offers Efficiency and Flexibility in Nucleic Acid Purification
A Single Plate for Multiple Applications Purified RNA or DNA is required for most molecular biology experiments and their isolation is often one of the first steps in disease pathways research. So RNA and DNA purification ... Continued
Allegro™ Microcarrier Delivery System: Streamline Processes, Increase Productivity
The AMDS promises to improve results and reduce costs by improving microcarrier weight accuracy and eliminating contaminations that can stem from microcarrier additions....Continued
Part II – A Look at the State of Cell Therapy – Current Manufacturing Options and Opportunities for Further Advancements
Introduction Yesterday we published Part I in this Cell Therapy series covering “Enabling Cell Therapy,” an informative supplement published by BioProcess International in conjunction with Pall Life Sciences. The publication contains twelve articles all covering various ... Continued
A Look at the State of Cell Therapy – Current Manufacturing Options and Opportunities for Further Advancements – Part I
While it is clear that new manufacturing solutions are needed for this burgeoning industry, there are also good resources currently available. This supplement does a great job highlighting manufacturing options and also pointing out areas where work still needs to be done....Continued
Options for Increasing Output and Reducing Footprint in Adherent Cell Culture
Introduction Adherent cell culture is often used in the manufacture of biologic products, including vaccines. Historically, the surface for cells to adhere to has been provided either by a two-dimensional (2D) system such as roller bottles, ... Continued
Viral Vector Production in the Integrity iCELLis Single-Use Fixed-Bed Bioreactor, From Bench Scale to Industrial Scale
A. Lennaertz (alenaertz@atmi.com), S. Knowles (sknowles@atmi.com), J.C. Drugmand, J. Castillo, ATMI LifeSciences Introduction Wild-type or recombinant viruses used as vaccines and human Gene Therapy vectors are an important development tool in modern medicine. Some have demonstrated high potential ... Continued
How to Ensure Integrity and Sterility of Single-Use Assemblies for Manufacturings
Introduction Single-use systems have many clear advantages, however, one challenge is ensuring the integrity of these plastic bags and components. Microscopic breaches of integrity, even those that cannot be seen, can allow microbial ingress. Possible breaches ... Continued