The phenomenal success of biological products in recent years has driven substantial advances in the science and technology surrounding bioreactors and bioprocessing. The rapidity of change and growing demand to fulfil market needs have created imperatives for increased capacity and efficiency, and for reduced production costs and batch-production timeframes. There is also a constant drive to attain adequate yields and meet the necessary standards of purification and stabilisation. Furthermore, emergent areas of research, such as tissue engineering, are often accompanied by their own complex and unique challenges. Alongside the issues of process development, maintenance and scale-up, there are stringent requirements to comply with regulatory standards.
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Bioprocessing is the development and manufacturing pipeline by which therapeutic agents such as engineered recombinant proteins, viral gene therapy vectors and other nanoparticle-based technologies are produced at levels required for commercial distribution. To achieve this end, large-scale cultures using engineered cell lines are grown in bioreactors or through other scalable approaches. These are constantly being refined and evolved to increase volume, product yield and efficiency. The adoption of next generation bioprocessing is reaching a decisive moment as biopharmaceutical companies are seeking new manufacturing methods that are essential to the industry's continued growth and innovation. It is more important than ever for the bioprocessing community to connect with one another, share ideas and strategise. Our event will offer unique insights through intensive research with key industry figures, combined with presentations and panel discussions to bring in-depth and informative content.
Today’s bioprocessing is the base of different emerging industries and technologies, including the production of therapeutic stem cells, gene therapy vectors, and new vaccines. Advances in bioprocessing is a special interest to the industry as it highly shortens the development timeline, improves the final product and increases the productivity of Bio-manufacturing facilities.
In this conference, leaders in biopharmaceutical production will investigate the latest technologies and manufacturing strategies for next generation biologics and advanced therapies. It will mainly focus on main challenges within the field, assessing innovative solutions such as continuous bioprocessing, SUTs, data integrity, PAT and the implementation of industry 4.0, all of which aim to increase the efficiency and yield of therapeutic production whilst maintaining high quality standards.
The International Bioprocessing and Biologics Forum will bring together more than 150+ industry experts from Large Pharma with interest in biotech, biotech, biopharmaceutical companies, contract manufacturing organisations, academic & research institutes, regulatory authorities, and solution providers, to discuss the latest developments, cutting-edge technologies, new challenges and opportunities in bioprocessing and best manufacturing practices to make better biologic drugs cheaper and faster!. So, what’s on the agenda for this year? Here’s a snapshot of what’s in-store on this year’s programme:
Evolution of Bioprocessing
Next Generation of Biologics Manufacturing
Gene Therapy at the Dawn of a New Era
Impact of Stress Factors on Protein Drug Products
LCMS Methods in Biologicals Formulation Development and in Quality Control
3D Printed Chromatography for Intensification of Downstream Processing of Biologics
Digital Twins for the Acceleration of the Bioproduct Life Cycle
Many more……
- Learn about biomanufacturing strategies to meet the needs of multiple modalities in biologics.
- Discover how high-performance simulation algorithms can optimise bioprocessing operations.
- Learn about bioprocessing technologies in biorefinery for sustainable production of fuels, chemicals, and polymers.
- Understand biopharmaceutical manufacturing trends.
- Analyse the efficacy of adaptive immune- cell therapy in patients with advanced gastric cancer.
- Understand what the regulatory expectations and challenges are.
- Explore how you can continue the evolution of vaccine development and manufacturing for the future
- Digital transformation & industry 4.0 in bioprocessing and biologics.
- Create a CMO selection process and criteria for successful project implementation.
- Explore the principles and practices of CMC analytics for cell and gene therapy.
- Overview of bioprocessing and biologics.
- Bioprocessing technologies.
- New directions in bioprocess development and manufacturing.
- The role of bioprocessing in building a bioeconomy.
- Financing and investment for biologics.
- Bioprocessing – applications and case studies.
- Regulatory strategies for intensified and continuous processing.
- Digital transformation.
· Learn about biomanufacturing strategies to meet the needs of multiple modalities in biologics.
· Discover how high-performance simulation algorithms can optimise bioprocessing Operations.
· Learn about bioprocessing technologies in biorefinery for sustainable production of fuels, chemicals, and polymers.
· Understand biopharmaceutical manufacturing trends.
· Analyse the efficacy of adaptive immune- cell therapy in patients with advanced gastric cancer.
· Understand what the regulatory expectations and challenges are.
· Explore how you can continue the evolution of vaccine development and manufacturing for the future.
· Create a CMO selection process and criteria for successful project implementation
· Explore the principles and practices of CMC analytics for cell and gene therapy.
Who Should Attend
VP’s, CEO’s, CXO’s, Heads, Directors, Senior Managers and Managers:
Bioprocessing
Biologics
Biomanufacturing
Biotherapeutics
Biotechnology
Biosimilars
Gene Therepy
Process development
Cell Line
ATMP Development
Quality Assurance/ Quality Control
Drug Substance
Tissue Engineering
Cell Culture
Therapeutics/Vaccines
Formulation
Continuous Manufacturing
Antibody
Drug Delivery
Bioanalytics
Virology
CMC Development
Upstream and Downstream Processing
Aseptic Processing
Digitalization
Regulatory Affairs/ Compliance
Bioproduction
Bioreactor
Single-use
Life Sciences
Purification
Fermentation
mRNA Delivery
Bioconjugates
Expand your network of top-level business contacts
Hear from enthusiastic speakers with powerful presentation
Use this exceptional platform for discussions and debates about then industry challenges
Benefit from our matchmaking and 1:1 meeting
Join our panel discussions, world cafe, interactive workshops, networking, strategic meetings and round tables discussion
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At the Leadvent Group conference you can request and organize your appointments by using a matchmaking app. Through the networking tool, each participant can create an individual profile. Guided by categories and keywords, attendees can search, find and approach interesting contacts. There will also be a networking area provided at the event of the conference. Your profile data and the details you provide are visible exclusively for registered participants within the event. You will oversee the information you would like to present and to whom. Our matchmaking app will be activated approximately one month prior to the conference and you will be notified vie e-mail as soon as you can start using the matchmaking App and can then set up your personal profile.
Steigenberger Airport Hotel
Stationsplein Zuid-West 951
1117 CE Schiphol
Amsterdam
For any general enquiries or questions please contact our team via email [email protected]
DELEGATE SALES
For booking information, please contact Martin Smith – Marketing Lead [email protected]
SPONSORSHIP
For booking information, please contact Martin Smith – Marketing Lead [email protected]
SPEAKER ENQUIRIES
If you are interested in speaking at the event please contact John Isaac – Event Producer [email protected]
MARKETING & MEDIA PARTNERSHIP
To create a media partnership please contact Martin Smith – Marketing Lead [email protected]
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Achim Treumann is an analytical biochemist with a strong interest in the characterization of biological macromolecules, including proteins and large oligosaccharide structures. Following a PhD in Michael Ferguson's laboratory at the University of Dundee, Scotland, he worked in academic and commercial environments as a leader of protein analytical laboratories in Japan, Scotland, England, Ireland and Belgium. Currently he is Principal Scientist Mass Spectrometry at KBI Biopharma BV in Leuven, Belgium.
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Dr. Behzad Mahdavi is a strategic growth business leader known for his expertise in developing successful, patient-centric business growth strategies across biopharma, and having a passion for advancing innovative technologies in cell and gene therapy, personalized medicine, synthetic biology, and the life sciences.
With over 20 years of senior leadership experience at companies such as Lonza, Catalent Biopharma Solutions, and Ginkgo Bioworks, Dr. Mahdavi has a proven track record of driving innovative strategies that generate remarkable sales and sustainable value growth in emerging market segments. In addition to his leadership roles, Dr. Mahdavi has made significant contributions as a member of multiple Boards of Directors and Advisory Boards. Holding a PhD in chemistry and an MBA in business administration, Dr. Mahdavi is a sought-after advisor for technology start-ups and large companies seeking help with fundraising, strategic business development, innovation management, sales expansion, and disruptive technology commercialization
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After graduating from the University of Manchester School of Chemistry, Ben joined Sanofi-Genzyme in Haverhill as a PAT scientist and then Abzena, working on the synthesis of ADC payloads and linkers. Ben then joined Lonza, researching and implementing new and advanced analytical technologies in the biopharmaceutical manufacturing process. Ben is now the Biopharma European Field Marketing Manager, focussing on Waters analytical solutions for bioprocessing.
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Dr. Letha Chemmalil is serving as as Scientific Associate Director at Bristol Myres Squibb in the Global Process Analytical Sciences & Technology group within the Biological Product Developemt division. Her prior affliations include working for major biopharmacetical companies such as Amgen, Genzyme, Seron, Wyeth and others. Letha’s areas of exertise include, analytical method developmet and protein characterzation utilizing Mass Spectrometry (LC/MS & MALDI-TOF MS) and Biophsical Characterization (CD, DSC, FTIR, Fluorescence Spetroscopy, etc.). Her academic background is spanning in the disciplines of Chemistry and Chemical Engineering. Letha’s passion for Process analytical technology (PAT) was evolved in response to hearing stories shared by industry practitioners in reference to the lack of rapid analytical methods for real-time monitoring and timely control of of CQAs. Round table discossions at variuos PAT consortiums also highlighted the deficite of reliable online analytical tools for suprting QbD driven process development and continuous bioprocessing. Letha believes that majority of the offline analytical methods can be performed at the online mode with an appropriate interface. Continuous evolution of chromatographic systems and column chmistries enable significant reduction in analysis time. With such padigm shifts, online chromatographic methods will surpass the spectroscopic methods that are calibrated against chromatographic method for predictive model building.
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Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. Since 2008, he is full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec, which is now part of Körber Pharma, pioneering data science software solutions for the biopharma life cycle.
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David Kelaher is Chief Medical Officer at Pharmaspectra. David has 20 years of experience in pharmaceutical Medical Affairs and healthcare communications, driving therapeutic portfolio success and international brand growth for several of the world's leading companies, such as Sanofi, Abbvie, and AstraZeneca.
He was previously Managing Director of BBH Health, a specialist strategic and creative business within BBH, one of the world's most awarded agencies. During his five years at the agency, BBH Health became global agency of record for HUMIRA, Symbicort and Brilinta, and led the global brand development and launch campaigns for Fasenra, Skyrizi and Rinvoq. Prior to this, David spent a decade at Sanofi, including Medical Affairs roles in the Australian affiliate, and as a Global Medical Director in the company's Paris headquarters.
He holds a Bachelor of Pharmacy from Sydney University and a Master of Science in Medical Science from Oxford University and is based in Paris.
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Having studied at the universities of Aberdeen and Sussex, Farzin’s early career was supported by Fellowships from the Beit Memorial Foundation, MRC and EMBO at universities of Sussex, Amsterdam and King’s College London (KCL). He was appointed to the Chair in Molecular Medicine at KCL in 1996, where he established the Rayne Cell Therapy Suite in 2001. This facility has produced the largest number of viral vectors for regulatory approved clinical studies in Europe (over 100 g-retro and Lenti-viral vectors in the last 5 years). He is also the Chief Scientific Officer at ViroCell Biologics, a recently established innovation driven CDMO, focused on the development and GMP manufacture of viral vectors. His current focus is on the development of vectors for targeted delivery and expression of therapeutic genes, and the rapid transition of gene therapy from discovery science into clinical studies. He holds an Honorary Chair at University College London and at the Technical University of Dresden. He has served since 2016 on the Clinical Trials, Biologicals & Vaccines Expert Advisory Group of the UK Commission on Human Medicines. He received the Distinguished Scientist Award, of the US Society for Experimental Biology and Medicine in 2016.
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Gerald currently works as Scientific Officer at Novartis Technical Research and Development (TRD) Biologics. He is member of the Novartis ICHQ12 implementation team and co-leads the TRD biologics QbD and Control Strategy initiative. Prior to joining Novartis, he gained professional experience in CMC and analytical development during his time at Roche and AbbVie. Gerald holds a Master's degree in Biology from the University of Constance and a PhD in Molecular Biology from the University of Jena (both Germany).
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John Moys is a European bioprocess systems specialist for Repligen Europe. He has over 35 years’ experience within the Bio Pharmaceutical and Diagnostics industries, in both up and downstream processing. He has over 25 year experience from the supplier perspective working in sales and technical applications support across the UK, Europe and Asia. Prior to this, he had accrued over 8 years of practical experience within manufacturing, quality control and R&D for the in-vitro diagnostics and antibody manufacturing sectors
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Maria Crespo is a director of Bioprocess Development within CSL Behring Bern. She has experience in leading and coordinating technology projects for the development of biological drug candidates. She is responsible for planning and supervising the development activities from lab-scale, up to pilot-scale to establish robust and scalable purification processes for drug development candidates to be transferred to GMP production. She has experience as CMC representative in cross-functional Project Teams; supporting technology transfer of relevant processes to external CMO's.
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Qifeng Zhang is a Global Senior Principal Scientist, focusing on novel protein therapeutics developability assessment and analytical strategy for product and process development from DNA sequence optimization to commercial release.
Qifeng earned his bachelor degree in biology in 1993 and PhD in analytical organic chemistry in 1998 from the Chinese Academy of Sciences.
Prior to joining Lonza, Qifeng successfully built up and led biopharma formulation and analytics development business with colleagues for former CMC development employer based on DoE-centered QbD strategy. Qifeng’s work in academia mainly concentrated on chromatographic purification of physiologically-active biomolecules and development of pioneering analytics for biological signaling, metabolism and immuno-oncology research.
Leveraging from his unique background, Qifeng passionately advocates for knowledge-driven CMC development strategy based on in-depth understanding of the molecule’s intended medical indications, physicochemical and biological properties, and potential interactions with neighboring components in vitro during manufacturing and in vivo post administration.
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Dr Sean Feast studied under Professor Conan Fee at the University of Canterbury to help develop Printed Monolith Adsorption (PMA or 3D printed chromatography). After completion of his PhD Sean has founded Precision Chroma, a start-up company that is commercialising PMA for applications in biological therapeutic purification and recombinant proteins for research to name a few. Sean is leading Precision Chroma to further developing and scaling up PMA out of the lab and into a manufacturing setting.
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My name is Tobias Hedberg. I hold a Phd in immunology from the University of Gothenburg and my work on dendritic cells and their response to adjuvants. Following my Phd I stayed at the University of Gothenburg for a postdoc position in Jan Holmgren's group working on a new adjuvant for an upgraded version of the cholera vaccine. After my postdoc I spent some time in a large pharmaceutical company before finding my way to VERIGRAFT. I have been employed there since early 2017 and my role in the company lies mainly within R&D/production.
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Tobias Rosenkranz is studying proteins, their folding, function and formulation for almost 15 years. He heads the Biomolecule Formulation R&D team within Process and Formulation Materials. His lab mainly focuses on formulation challenges arising in protein formulations, such as protein viscosity and aggregation. A biophysicist by training, he holds a PhD from the HHU Düsseldorf/Research Centre Jülich. Prior to joining the company in 2017, Tobias was a basic researcher at UIUC (US) and UNSW Australia.
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Dr. Trevor P. Castor, President and CEO, Aphios International, Woburn, MA, has over 30 years of diversified experience in technology and business development, management, marketing and finance in the biotechnology industry. He graduated from the University of California, Berkeley with a Ph.D. in Mechanical Engineering and a MSc in Chemical Engineering, and summa cum laude with a BSc in Chemical Engineering from the University of Toronto, Canada. He studied Business Administration at St. Mary’s College, Brooklyn, NY, and Management, Marketing and Finance at the Harvard University Extension Program, Cambridge, MA. He is the author of over a 100 issued and pending US and international patents on SuperFluids™ pathogen inactivation technologies, other enabling technology platforms and enhanced therapeutic products. He has collaborated with several pharmaceutical and biotechnology companies including Eli Lilly, BMS, Novartis, Pfizer and Merck-Millipore-Sigma.
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Dr. Ole Wohlenberg obtained a Life Science degree from the Leibniz University of Hannover and subsequently conducted his PhD at the Institute of Technical Chemistry. His research has been focused on the implementation of Quality by Design principles in biopharmaceutical production processes. In the course of his studies, he has been working with various cell types and bioreactor systems to determine effects of critical process parameters on process and product quality attributes. Ole Wohlenberg is currently working as a post-doctoral researcher and will be responsible for the cell culture establishment and 2D fluorescence sensor development in Hannover.
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Corinna started working in analytical development at Boehringer Ingelheim in 2018. She has a Master´s degree in Analytical & Bioanalytical Chemistry and hands-on expertise in High Pressure Liquid Chromatography, Capillary Electrophoresis and Mass Spectrometry. In her current position as Analytical Expert she is working with HPLC-based methods to monitor biopharmaceuticals in early and late stage process development as well as in 2nd generation development processes. One focus of her work is the optimization of analytical methods based on process needs
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Anja Müller holds a master’s degree in physics from the Technical University of Berlin.
Over the course of her studies, she acquired relevant knowledge and skills in the field of MIR spectroscopy.
She is co-founder and CEO of the biotech start-up IRUBIS based in Munich, Germany.
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Rolf comes with 9 years experience in the bio-decontamination business with Ecolab. Rolf studied in Cologne Germany and did his PhD at the Max-Planck Institute on Molecular Biology. Throughout his professional career Rolf learned a lot in the areas Molecular Biology research and diagnostics. He gained a lot of insights into cell and gene therapy treatments while working with one of the leaders in that field in a senior sales director role. Currently he serves Ecolab as an cell and gene therapy expert.
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Bjørn Voldborg is the Head of the National Biologics Facility at the Technical University of Denmark (DTU) and he has more than 20 years of experience, from both academic and industrial settings, working with recombinant protein production. Bjørn was team leader in the biotech company Pharmexa A/S for more than 8 years, responsible for molecular cloning and expression of protein-based drug candidates. In 2009, he went to the NNF Center for Protein Research at the University of Copenhagen as Head of the Protein Production Unit, and, since 2012, Bjørn has been heading the CHO Cell Line Engineering research at DTU dedicated to the engineering of improved protein production cell factories. Since 2021 he has been heading the Cell Line and Protein Production Facility and the National Biologics Facility at DTU. From January 2024, Bjørn is also function as Senior Advisor in Mammalian Cell Technologies at Bioneer A/S, a non-for-profit CRO.
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Nic Preyat holds a PhD in Immunobiology. His academic research focused on understanding cell and molecular mechanisms controlling the immune response, and cell death pathways. During his post-doctoral studies, Nic Preyat investigated the possible implementation of new therapeutic strategies to fight cancer. He also developed tools to characterize biomarkers for inflammatory diseases. Nic had several scientific and leadership positions within two global CDMOs, Masthercell and Catalent, developing and manufacturing cell and gene therapy products. Nic Preyat had contributed to the development of various products ranging from viral vectors to CART from early development to transition for commercial manufacturing. At UCB Nic Preyat is now leading a team responsible for the development and manufacturing of rAAV with the ultimate goal to treat patients with neurodegenerative disorders. Through the various positions he assumed, Nic Preyat has acquired a strong expertise in cell culture, CMC development, technology transfer, good manufacturing practices and project management
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Marco Bieri is a Senior Scientist in the Biologics Analytical R&D group at MSD and joined the company in 2017. In the last several years he implemented novel Process Analytical Technology (PAT) tools and methods for Biologics from R&D to GMP facilities for Continuous Manufacturing. Marco holds a BSc. in Pharmaceutical Biotechnology from Zurich University of Applied Sciences.
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A Project Management and Manufacturing Systems consultant with a focus on digitization in Life Sciences manufacturing and processing. Barry has spent over 25 years managing complex software and digital transformation projects for major Life Sciences companies. Barry has established a strong reputation internationally for his expertise in systems design and project management, and has assisted numerous clients in defining a digital roadmap for their business.
Known for his creative and innovative approach, Barry has held senior positions in Life Sciences manufacturing, processing, systems integration, and consulting firms. His specialization lies in electronic manufacturing batch records (eBR) design, project recovery and regulatory compliance
Barry has managed the transformation of several manufacturing and processing operations from paper records to electronic batch records for many of the world’s top Life Sciences companies.
He is a regular speaker at international Project Management and Life Sciences conferences, and serves as an industry consultant to Universities in Ireland.
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I am a bioprocess engineer with a hands-on experience on projects in the biotechnology industry. I work with process optimization and delivering creative innovations to the biofuels industry because I believe in a greener fuel industry and a more sustainable future. At Raizen, I work with data analysis, process monitoring and troubleshooting. My team and I work to ensure that the second-generation ethanol plant keeps its position as pioneer on this breakthrough technology. All in a very dynamic and enthusiastic environment.
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Experienced Senior Vice President New Business with a demonstrated history of working with multinational companies as they drive their international growth. Recently worked with Apple, Facebook, Biomarin, Aerie and OPKO Healthcare. Strong operations professional with extensive knowledge and experience of establishing international operations. Currently heading up the Emerging Business and New Forms of Investment teams
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Stefano Baila received his PhD in 2007 based upon translational research and development of gene therapies for hemophilia at the Children’s Hospital of Philadelphia. Since that time he has been actively involved in the process development and manufacturing of advanced therapeutic medicinal products through business development and strategic marketing roles at Areta International, a CDMO, and by leading field implementation and commercialization activities for the cell processing unit of Terumo BCT. Stefano worked as Industrialization Manager at Celyad where he led process development and automation efforts for CAR-T and later on he did join Anemocyte as Director of Operation and Business Development. Now he serves as Managing Director for Eurofins
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Twinkle Christian is a Process Development Sr. Scientist at Amgen. She has 20 years of experience in drug product development across diverse modalities and has led the advancement of multiple programs from early discovery to clinical trials and commercialization. Twinkle’s expertise encompasses high concentration formulation development and drug delivery of biologics, investigating protein-protein interactions, and macromolecular crystallography. She is an inventor on multiple patents related to formulation and drug delivery. Twinkle is an adjunct lecturer at California State University, Channel Islands. She holds a Master’s in Biochemistry and Molecular Biology and was employed at Alza (Johnson & Johnson) and VaxGen prior to Amgen.
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Marcel Thön is a molecular biologist with strong interest and experience in the field of cell line development for recombinant production of therapeutic proteins. After his PhD at the Leibniz Institute for Natural Product Research and Infection Biology (Hans Knöll Institute) in Jena, Germany, he worked as group leader in the central R&D department of the Wacker Chemie AG in Munich with focus on different biotechnological topics such as production of natural compounds by metabolic engineering of E. coli and yeasts as well as continuous improvement of the proprietary E. coli based ESETEC® system for secretory production of recombinant proteins. Currently, he is Senior Expert of Bioprocess Development and Head of “Competence Center for Cell Line Development” at the Wacker Biotech GmbH, Germany.
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Dr Bhavik Mehta is an Applications Engineer in the Pharmaceutical Industry Strategy Area team at Siemens Industry Software Ltd. He obtained his degree in chemical engineering in 2015 at the University of Nottingham and his PhD in engineering 2020 from the University of Liverpool. Before joining Siemens, Dr Mehta spent two years working as an academic research associate. His research focused mainly on developing systems models for pharmaceutical R&D applications, including biological applications, through population balances. His work now focuses on applying Siemens’ mechanistic and hybrid solutions for various pharmaceutical applications, including bioprocessing.
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As Manufacturing Science and Technology Expert at VTU Engineering, Clara Kröger (Dr. rer. nat.) supports customers in the pharmaceutical and biotech industries in the late stages of process development and in commercial manufacturing. She received her PhD from Ulm University for investigating the role of the TANK-binding Kinase 1 protein in correlation with the neurodegenerative disorder Amyotrophic Lateral Sclerosis. During her career in pharmaceutical industry she gained profound knowledge in the late stages of process development and in the transition to commercial manufacturing. Her knowledge in the biotech field is covering CMC development of biosimilars, process characterization and process validation, technology transfers as well as project management.
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Marc Hummersone has over 20 years of project and managerial experience in both big and small technology companies, including industry leaders AstraZeneca, General Electric Healthcare & Cytiva. He has a broad experience base across a wide range of technologies including the development of novel chromatographic media for the purification of complex biological feed streams as well as drug discovery and development. He was a key contributor to the development of the Fibro chromatography family of products which resulted in the acquisition of Puridify, by GE Healthcare in 2017. Additionally, he was a key part of the management team who validated the concept of synthetic lethality and who identified and developed Lynparza, which is an approved drug for the treatment of BRCA-mutated advanced ovarian cancer which resulted in the acquisition of KuDOS Pharmaceuticals in 2005, by AstraZeneca. Marc has held positions including Company Director, Chief Scientific Officer and Department Director. He gained a PhD and Post-Doctoral experience in chemistry which was focused on the total synthesis of complex natural products at University College, London
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Guido currently holds the position of Vice President Life Sciences at JSR Life Sciences. He is leading the extension of the bioprocess materials portfolio and also heading the European sales and customer support team. Previously, he was CEO and co-founder of ChromaCon AG, a Swissbased provider of chromatography process technologies and equipme
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Aoife has over 20 years experience in ATMPs, specifically GMP manufacturing, Quality Control and Quality Assurance. Aoife is leading the Cell and Gene Therapy Operations at Hitech Health where she manages the CDMO facilities in Galway, Ireland- this includes full suite of cleanroom facilities, including Grade A/B and Grade C cleanrooms, Quality Control and Microbiology laboratories, as well as Process Development services. Aoife has successfully led the manufacturing and approval of 4 cell therapy clinical trials within Ireland and Europe and has extensive experience in regulatory affairs
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The phenomenal success of biological products in recent years has driven substantial advances in the science and technology surrounding bioreactors and bioprocessing. The rapidity of change and growing demand to fulfil market needs have created imperatives for increased capacity and efficiency, and for reduced production costs and batch-production timeframes. There is also a constant drive to attain adequate yields and meet the necessary standards of purification and stabilisation. Furthermore, emergent areas of research, such as tissue engineering, are often accompanied by their own complex and unique challenges. Alongside the issues of process development, maintenance and scale-up, there are stringent requirements to comply with regulatory standards.