Gold 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: Manager, Continuous Bioprocess, Scientific and Laboratory Services Europe
Job Title: Global Product Manager, Chromatography Sorbents & Membranes
Job Title: Bioprocess Specialist
Job Title: Global Product Manager
Job Title: Senior Global Marketing Manager, Cell & Gene Therapy
Job Title: Director, Accelerator Process Development Services
Job Title: Biopurification Specialist
Job Title: Manager SLS Purification Consultants Europe
Job Title: Global Product Manager for the Mixing portfolio
Job Title: Senior R&D Manager
Job Title: Senior Marketing Director – Downstream Processing
Job Title: Global Product Manager
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
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
Subcutaneous Drugs: Challenges and Considerations in Downstream Manufacturing
The last decade has seen an increasing trend towards the development of biologic products across many disease areas that can be delivered by subcutaneous (Sub-C) injection as an alternative to conventional intravenous (IV) formulations. Subcutaneous ... 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
Mustang Membrane Technology for AAV Empty and Full Capsid Separation
Interest in Adeno-Associated Virus (AAV) purification approaches have been increasing with recent AAV based gene therapy regulatory approvals. Purification approaches that have been developed for monoclonal antibodies and other recombinant proteins have been modified for ... 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 the ... Continued
Full Adeno Associated Virus (AAV) Capsid Enrichment Using Mustang® Q Membrane
Mustang Q XT step gradient elution demonstrated full capsid enrichment of 4-5-fold and produced elution fractions with ~100% full capsid content Adeno-associated virus (AAV) vectors are becoming increasingly important gene delivery platforms for the development of ... 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
Downstream Manufacturing of Gene Therapy Vectors
In summary, there is an increasing range of options to process and obtain high titers and high-quality batches of viral vectors. We expect continued advancement and the future is open to new innovations and capabilities that should reduce complexity, lessen the challenges, and lower costs. In many ways, the industry is taking a similar path to the monoclonal antibody industry several years ago with expansive growth and manufacturing capabilities....Continued
Viral Filtration Validation Study Design – A Systematic Method for Choosing the Most Appropriate Test Approach
I recently read a set of application notes in which Pall Biotech shares their experience validating the Pegasus™ Prime Virus Removal Membrane Filters and the Pegasus™ Protect Virus Filters. In the note, they address both the issue of spike selection and incorporation of virus prefilters into study design. I found the included decision trees to be very helpful as well....Continued
Bioburden Control Strategies for Continuous Downstream Processing
To provide clarification on strategies for bioburden control in continuous downstream processing, Pall’s Britta Manser, Manager, Continuous Bioprocess, Scientific and Laboratory Services Europe, presented a video where she provides specific strategies that can be implemented to minimize bioburden in continuous downstream operations....Continued
Innovative Sorbents Enable a Robust and Streamlined Protein Purification Process
Purification has traditionally been slower to innovate mainly due to the difficulty in changing existing downstream processes, the lack of a universal purification process, and the low capacity of mixed mode chromatography sorbents that has limited their use despite their high resolution. To address these issues, Pall® Biotech recently presented a chromatography process which combines KANEKA KanCapA sorbent, Mustang® Q chromatography membrane and CMM HyperCel™ sorbent. This three-step process has been demonstrated to eliminate the need for diafiltration or dilution between chromatography steps....Continued
Optimizing mAb Purification with Highly Selective Mixed-mode Cation Exchange Sorbent
This high-performance, salt-tolerant, mixed-mode cation sorbent combines the selectivity power of a mixed-mode sorbent and the high binding capacity of a cation exchanger....Continued
A Guide for Selecting the Correct Filter Integrity Test Instrument
In this guide, we have outlined a helpful set of criteria to help you compare and evaluate the features of the best-in-class integrity test instruments and to make informed choices. We have also highlighted helpful tips for working with suppliers to ensure you collect all the information you need to make the best decision....Continued
Continuous biomanufacturing – Key drivers for adoption, economic modelling and regulatory considerations
The publication includes seven articles covering the topic of continuous biomanufacturing from a variety of angles. I really enjoyed the eBook and it provided a great update on the current state of continuous biomanufacturing as well as information about key drivers for adoption, new economic modeling, and integration of continuous operations. Following is a sampling of articles with key highlights....Continued
Inline Diafiltration Closes the Gap for End-to-End Continuous Bioprocessing
Specifically designed to meet the needs of continuous bioprocessing by supporting key diafiltration applications. These applications include: buffer exchange for final drug substance, desalting or buffer exchange before or after column chromatography, and small molecule contaminant removal....Continued
Implementing Process Analytical Technology (PAT) in Continuous Bioprocessing
The poster, “Process Analytical Technology (PAT) For Continuous Bioprocessing,” presented by Edita Botonjic-Sehic, Pall Corporation, discusses key steps in implementing PAT and enabling on-line and at-line real time continuous monitoring and automation....Continued
Cell Harvesting – Selecting a technology compatible with cell density and feed turbidity
Silke Bergheim-Pietza, Global Product Manager Depth Filtration, Pall. discusses challenges faced in the cell harvesting step, in particular, selecting the best cell harvesting method based on the cell density and feed turbidity of the process and meeting the demand of increasing cell densities. Download the cell harvesting technology selection guide and use the guide to compare the latest single-use harvesting technologies....Continued
Continuous Biomanufacturing Implementation Now and in The Future
Dr. Peter Levison, Senior Marketing Director – Downstream Processing, Pall Biotech talks about the evolution and benefits of continuous biomanufacturing, what implementation looks like today and what still needs to be realized for full industry adoption....Continued
Validation of Virus Filtration in Continuous Bioprocessing
Adoption of continuous processes certainly seems on the biomanufacturing horizon and this is not surprising considering the benefits of an integrated continuous approach. Demonstrated benefits include operational flexibility and efficiency, product consistency, increased quality assurance, ... Continued
Downstream Bioprocessing Cost Modeling – Looking at Integrated Continuous, Single-use and Stainless Steel Platforms
To identify the most cost-effective downstream monoclonal antibody (mAb) purification strategy, Dr. Schofield and his team modeled different unit operation sequences using BioSolve Process*....Continued
Optimize Downstream Processing with Single-Pass Inline Concentration
Eliminating the recirculation loop by using a unique flow path design and cassettes staged in a serial and parallel configuration, SPTFF is a viable option even for shear-sensitive proteins. Yields are also often higher because of improved product recovery and lower system working and hold-up volumes....Continued
Achieve Integrated and Scalable Continuous Chromatography
Over the last decade, advances in the upstream processing of monoclonal antibodies (mAbs) has resulted in higher bioreactor titers. With increasing titers, the production bottleneck has shifted to downstream processing. Hence, the biopharmaceutical industry has reached a milestone where the need for higher throughput in downstream processing is leading to the adoption of more efficient multi-column continuous (MCC) counter-current chromatography systems which increase overall productivity while significantly reducing consumables cost...Continued
Continuous bioprocessing – moving from theory to reality
Continuous manufacturing has been established in several processing industries for many years, providing many benefits over batch manufacturing. The feasibility of continuous processing has now been shown for monoclonal antibodies (mAb) at both the process development (PD) and the production scales by early adopters....Continued
A Look at the Current State of Continuous Bioprocessing
I found the supplement to be a useful update on continuous bioprocessing technology benefits, implementation challenges and successes, as well as what the future holds. Following is a sampling of articles with key highlights....Continued
Cadence Single Pass TFF Provides in-line Concentration, Enables Continuous process
The Cadence ILC permits in-process concentrating, which benefits continuous process applications such as perfusion culture methods. Concentration of bioprocess fluids with lower protein titer, such as those generated during perfusion, before multi-column or continuous chromatography enables significant process cost reduction. Continuous processing is also enabled by the easy integration of the Cadence ILC and its ability to couple a variety of processes for overall process integration....Continued
Clarification Using Acoustic Wave Separation Offers Advantages including -Continuous Process Solution
The harvest and clarification of cell culture bioprocess fluids removes cells and cell debris and provides clarified cell culture harvest fluid for downstream purification. The success of the clarification step can greatly impact efficiency and ease of downstream purification....Continued
Integrity Testing of Flexible Container Using the Helium Integrity Testing (HIT) Platform (2-D and 3-D Bags and Manifolds)
Switching to single-use systems (bags and hardware) can have financial and performance benefits. However, one of the critical challenges for complete acceptance of single-use systems is assurance of bag integrity which in turn means assurance of product sterility and operator safety....Continued
