Join us for a discussion with leading industry experts
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The demand for more efficient and agile downstream purification processes for diversified therapeutic antibody pipelines require the development of new strategies and technologies.
Join us November 19 and learn from industry experts on recent advancements and the future of antibody purification.
By signing up for this panel discussion and breakout sessions you will learn more on:
Register 19 November 2020 10:00 AM EDT | 16:00 CET
Michel Eppink, Senior Director Downstream Processing, Byondis, BV
Karen Dickson, Group Leader Protein Expression and Purification, Kymab, UK
Paul Randolph, Downstreem Processing Lead, Janssen, US
Gunnar Malmquist, Principal Scientist, Cytiva
Michel Eppink: Michel received his MSc. in Biology/Chemistry in 1993 from the University of Utrecht and his PhD in 1999 from the Wageningen University and Research at the Laboratory of Biochemistry with background in structure/function relationships of proteins. Michel Eppink has more than 30 years of experience in Downstream Processing and currently is Senior Director Downstream Processing at Byondis BV heading a department of 30 highly skilled coworkers developing purification/formulation processes for biopharmaceutical proteins such as monoclonal antibodies and antibody drug conjugates.
Next to that Michel Eppink is Special Professor at the Department of Bioprocess Engineering at Wageningen University and Research heading a group of PhD candidates in the research of biorefinery technologies such as new purification/analytical techniques for proteins/lipids/carbohydrates from different eukaryotic organisms (e.g. mammalian cell lines, macroalgae, microalgae, yeast). In the Netherlands Michel is a section member of the Downstream Processing section of the Dutch Biotechnology Association. Internationally he is chair of the Microalgae Bioengineering Section of the European Society of Biochemical Engineering Sciences (ESBES) and scientific committee member of the International Symposium of Proteins and Peptides Purifications (ISPPP).
Karen Dickson: I obtained my degree in Microbiology from Liverpool university and did a PhD in Biotechnology at Birmingham university. Since then I have worked exclusively in industry in both small biotech companies and large pharma mainly based in Cambridge, UK. Initially I worked on enzyme purification from E.coli, yeast and insect cells systems to support pharmaceutical development of assays, structural analysis for drug design and production of biocatalysts. I have dabbled in molecular biology and protein expression systems over the years, but my main passion has always been purification at both research lab scale and development. The last 15 years I have been focused on antibody purification, developing processes, liaising with CDMO’s, managing purification, and expression teams and trying to improve the flow of pipeline projects from research to development.
Paul Randolph: Paul Randolph has more than 30 years of experience developing, transferring and supporting commercial biologic manufacturing, with a focus on downstream processing. He is the currently the Janssen DSP lead for the Mosaic GP140 (HIV vaccine) purification process. In addition to project support, he is responsible for leading the Janssen Parenteral Center of Innovation (PCI) Downstream Sub-team and driving downstream technical developments such as Protein A resin lifecycle management improvements and chromatography profile analysis (GDTA) across our internal and external sites. Throughout his career he has been involved with and lead efforts in process intensification and to improve process productivity, efficiency. Paul is active in the BPOG Continuous DSP and NIIMBL Flexibility workstreams.
Gunnar Malmquist: Gunnar Malmquist is a principal scientist at Cytiva and an analytical chemist by training with focus on chromatography and data analytics. He started his career at Pharmacia Fine Chemicals in 1979, working with quality control of chromatographic separation resins. He was later involved in the development of the ÄKTATM chromatographic system and the UNICORNTM software, before moving in 1997 to development and characterization of preparative chromatographic resins. He has been responsible for the design of several of the leading resins on the market, including MabSelectTM and CaptoTM. Currently he is focused on resin design strategies, Quality by Design and PAT, as well as using multivariate data analytics and mechanistic modelling to understand biomanufacturing processes.
Register 3 December 2020 10:00 AM EDT | 16:00 CET and on-demand
Production and development of biopharmaceutical proteins (e.g. monoclonal antibodies) is mainly performed in Chinese Hamster Ovary (CHO) cells. The process development of these biotherapeutic proteins includes Upstream and Downstream process development. During the Downstream Processing the protein of interest is purified according a chain of purification steps whereby affinity separation is mostly the first step in the chain yielding a product purity > 90%.
Protein A chromatography is one of the most powerful tools for antibody purification due to its high selectivity and recovery. During the protein A step, a great part of impurities are removed from the solution. One class of residual impurities represents high molecular weight (HMW) species which are likely to generate immune responses even when very small amounts are present.
Typically, during antibody purification, protein A chromatography is used as a capture step, followed by an intermediate chromatographic step which is almost entirely dedicated to the removal of HMW species. When the removal of HMW species could be implemented during the capture step, the intermediate step could possibly be removed leading to a more economical and robust DSP process.
In this study, the potential of Protein A chromatography to separate antibody monomer from HMW species was investigated. A design of experiments approach was used to study the influence of four factors on the removal of HMW species: (1) elution buffer type, (2) conductivity of the elution buffer, (3) pH gradient length and (4) Protein A resin type.
During this study it was shown that HMW species can potentially be separated from antibody monomer by Protein A chromatography to the desired levels while maintaining an acceptable monomer recovery. This would result in the use of a more efficient Protein A step and allow for reduction of DSP economics.
Michel received his MSc. in Biology/Chemistry in 1993 from the University of Utrecht and his PhD in 1999 from the Wageningen University and Research at the Laboratory of Biochemistry with background in structure/function relationships of proteins. Michel Eppink has more than 30 years of experience in Downstream Processing and currently is Senior Director Downstream Processing at Byondis BV heading a department of 30 highly skilled coworkers developing purification/formulation processes for biopharmaceutical proteins such as monoclonal antibodies and antibody drug conjugates. Next to that Michel Eppink is Special Professor at the Department of Bioprocess Engineering at Wageningen University and Research heading a group of PhD candidates in the research of biorefinery technologies such as new purification/analytical techniques for proteins/lipids/carbohydrates from different eukaryotic organisms (e.g. mammalian cell lines, macroalgae, microalgae, yeast). In the Netherlands Michel is a section member of the Downstream Processing section of the Dutch Biotechnology Association. Internationally he is chair of the Microalgae Bioengineering Section of the European Society of Biochemical Engineering Sciences (ESBES) and scientific committee member of the International Symposium of Proteins and Peptides Purifications (ISPPP).
22 April 10:00AM EDT | 16:00 CEST Register
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and suppliers must address them immediately by analyzing data, determining the root cause and minimizing the variability. You can reduce variability across the biopharmaceutical value chain by characterizing raw materials, monitoring materials quality, and controlling raw material usage.
Aaron has 20-years experience working in IT in the cell culture industry, with the last 3 years being spent leading digital transformation efforts. Aaron has a successful track record in designing and building IT solutions to enhance business performance, speeding the flow of information, and collaborating with customers.
29 April 10:00AM EDT | 16:00 CEST Register
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, Cytiva introduced Chronicle™ - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare’s Life Sciences business, now Cytiva, in 2013 and has been an actively involved in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development products and services into the Cell and Gene Therapy space.
6 May 10:00AM EDT | 16:00 CEST Register
To address the growing demand for plasmid DNA, Cobra Biologics have embarked on a collaborative project with GE healthcare to develop a second generation PlasmidSelect resin based on Cytiva’s Capto bioprocessing resin. This presentation with look at the needs within the plasmid DNA market and how this collaboration has sought to address this market opportunity
Tony has over 35 years of experience in the large-scale manufacture of biopharmaceuticals. As a founding staff member of Cobra Tony has been responsible for the development of much of Cobra’s manufacturing technologies in the field of DNA and virus production. He has held a number of senior roles, managing both manufacturing and development functions within the company, working on over 40 programs for the development of novel therapeutic products including protein, recombinant virus, bacteriophage and plasmid DNA products. His current role is based in the commercial group and support external collaboration and outreach activities. Additionally Tony is currently a member of the BIA Science and Innovation Advisory Committee (SIAC) and of industrial advisory boards for Aston and Loughborough Universities
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
29 April 10:00AM EDT | 16:00 CEST Register
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, Cytiva introduced Chronicle™ - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare’s Life Sciences business, now Cytiva, in 2013 and has been an actively involved in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development products and services into the Cell and Gene Therapy space.
29 April 10:00AM EDT | 16:00 CEST Register
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, Cytiva introduced Chronicle™ - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare’s Life Sciences business, now Cytiva, in 2013 and has been an actively involved in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development products and services into the Cell and Gene Therapy space.
29 April 10:00AM EDT | 16:00 CEST Register
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, Cytiva introduced Chronicle™ - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare’s Life Sciences business, now Cytiva, in 2013 and has been an actively involved in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development products and services into the Cell and Gene Therapy space.
29 April 10:00AM EDT | 16:00 CEST Register
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, Cytiva introduced Chronicle™ - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare’s Life Sciences business, now Cytiva, in 2013 and has been an actively involved in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development products and services into the Cell and Gene Therapy space.
29 April 10:00AM EDT | 16:00 CEST Register
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, Cytiva introduced Chronicle™ - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare’s Life Sciences business, now Cytiva, in 2013 and has been an actively involved in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development products and services into the Cell and Gene Therapy space.