Biologics Manufacturing 5.0 2024, is a part of the Biologics Manufacturing World Series with a focus on AI and digitalization's profound impact on bioprocessing.
With a decade of successful operations, the Biologics Manufacturing World Series has firmly established itself as a prominent player in the industry. At the forefront of this series, is a conference poised to redefine the future of biopharmaceutical manufacturing. In an era where the convergence of cutting-edge technologies, AI and digitalization are reshaping industries, we bring together global biopharmas to explore the transformative potential of Industry 5.0 in Biologics Manufacturing.
Our conference agenda covers vital themes: AI for continuous manufacturing, real-time modeling in commercial production, and cloud-based collaboration. We also explore Cell Line Development, Raw Materials, ICH guidelines, streamlined processing, continuous manufacturing integration, and process intensification. This strategy enhances efficiency and productivity, involving process modeling, control, and advanced analytics, offering cost reduction and higher titers while maintaining quality.
This 3-day event will bring together industry leaders from pharma, biotech, academia, and solution providers to foster high-level participation and facilitate meaningful dialogue. Our conference program includes masterclasses, panels, presentations, and breakouts, uniting forward-thinking leaders from various sectors to discuss key topics in Bioprocessing and Smart Manufacturing. We'll delve into major challenges, innovations, and emerging technologies.
Dimitrios Lamprou (Ph.D., MBA) is Full Professor (Chair) of Biofabrication and Advanced Manufacturing, and Director at MSc Industrial Pharmaceutics at Queen’s University Belfast. He is also the Chair at United Kingdom and Ireland Controlled Release Society (UKICRS) and the Chair of the Academy of Pharmaceutical Sciences (APS) Emerging Technologies Focus Group. Dimitrios, is the author of over 150 peer-reviewed publications, has over 350 conference abstracts, has given over 150 Invited Talks in institutions and conferences across the world, and has secure Funding more than £3M. Dimitrios has been recognised as world leader in 3D Printing with PubMed-based algorithms placed him in the top 0.087% of scholars in the world writing about 3D Printing in the past 10-years. Moreover, PubMed-based algorithms placed him in the top 0.11% of scholars in the world writing about microfluidics, and in the top 0.64% of scholars writing about nanofibers. Dimitrios has also been named in the Stanford University’s list 2021 & 2022 of World’s Top 2% Scientists, for his research in Pharmaceutics and Biomedical Engineering. For more info, please visit www.emergingtechnologieslab.com.
Federica Fraschetti has spent her entire career in the Pharmaceutical Industry, developing an expertise in Manufacturing of Sterile Drug Product (DP) and Secondary Packaging at Contract Manufacturing Organizations (CMOs). In her current position at MSD, Federica is responsible for overseeing DP manufacturing operations for New Product Introductions, working across multiple CMOs . In her career, Federica hold various positions in the Operations field at Biogen, BMS and MSD and had extensive experience in Tech Transfer (TTs), managing Projects and overseeing Commercial Manufacturing at External Partners (EPs).
Federica holds a Masters in Biomedical Engineering from ETH Zürich, and a Bachelor degree in Clinical Engineering from La Sapienza University of Rome.
Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., Rahway, NJ., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.msd.com
Greg serves as Head of cGMP Strategic Supply and Operations at the mRNA Center of Excellence at Sanofi, where he is responsible for all aspects of clinical production and raw material supply chain. He joined Sanofi via acquisition of Translate Bio, where he was Chief Manufacturing Officer and responsible for Technical Operations. Over his 20+ year career in the drug delivery field, Greg had various roles leading the pharmaceutical development of complex formulations, including numerous nano- and microparticle based systems. This includes leading groups for Formulation Development, Process Development, Analytical Development, Supply Chain Management, Manufacturing and Facilities at companies including Pfizer, Seer, BIND Therapeutics, Alkermes, and Guilford Pharmaceuticals. He’s brought myriad novel products into the clinic and helped commercialize five. Greg received his MSE and BS in Biomedical Engineering from The Johns Hopkins University and was elected and inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows in 2020 for recognition of his accomplishments in drug delivery.
Juergen Hubert Blusch
Mathilde has served as Contract Manufacturing Lead since November 2020 after various roles in marketing and business development within Labatec. She is now working for corporate development and contract manufacturing department to ensure continuous growth for the company. Prior to joining the group, she worked as executive manager for a healthcare provider in USA.
Mathilde holds a degree in Biochemistry and a Master in international business.
Philippe Jaïs, MD, PhD, is the President and Chief Scientific Officer of Eukarÿs. He obtained his doctorate in medicine and his doctorate in molecular human genetics from the Paris VII University. Philippe has served at several scientific a management positions in Pharma (Sanofi, Solvay Pharma, Hoffmann-LaRoche) and Biotechnology (Genset, ProteaBio, AzurRx). Philippe Jaïs is the inventor of the C3P3 technology and has cofounded Eukarÿs. He has also authored more 50 scientific publications and filed a dozen patents.
Richard is a Subject Matter Expert in the pharmaceutical temperature controlled supply chain. He has specialisation and expertise in packaging, temperature monitoring, and real-time monitoring technologies.
He has a broad knowledge of freight management. Deep understanding of the challenges faced within a complex supply chain. In-depth knowledge and understanding of global regulations pertaining to Good Distribution Practices
An author of presentations, white papers and technical reports. Experienced trainer. Fully qualified and trained Responsible Person. Experienced and knowledgeable Project Manager and Validation Manager in the implementation of pharmaceutical manufacturing facilities, equipment and supply chain operations.
Sonia Ben Hamida
As Head of Special Cargo at the International Air Transport Association (IATA), Sonia leads the development of the special cargo agenda, delivering standards, business processes, and solutions for the air cargo supply chain related to the transport of live animals, perishables, and temperature-sensitive cargo, and all other special cargo.
Prior to joining IATA, she held several roles in France where she spent 8 years driving innovation in the aerospace industry. Then she joined academia in 2019 as a lecturer and researcher at EPFL, the Swiss Federal Institute of Technology in Lausanne, and UNIGE, the University of Geneva. Over the past 12 years, she has built a strong expertise in project management, innovation, design, and business and systems modeling.
she holds an engineering degree in Aviation and Computer Science from the French Civil Aviation University - ENAC (France) and a PhD in Innovation from CentraleSupélec (France). She is passionate about innovation and design and enjoy spending my free time in nature biking, hiking, and climbing.
Head of Operations (COO), BioAtrium AG, Switzerland
Prof. Dr. Thomas Bieringer is SVP & Global Head of Advanced Manufacturing-Platform Engineering and Support, leading a team of bioprocess engineers that is accountable to deliver process equipment and digital solutions to realize Bayer’s biologics therapies. Thomas has more than 20 years of professional and leadership experience in product-, technology- and business development. Prior to his current role he was leading Bayer’s process development unit, providing all unit operations for chemical and biological production; he was as well founder and managing director of the public-private-partnership INVITE. Thomas holds a PhD in Physics.
Bioprocessing 5.0: Status and Development of Digital Transformation in Biomanufacturing
AI in Biomanufacturing
Advancements in Cell Line Development, Culture Media, and Raw Materials.
Analytics & Quality
Streamlined Processing, Purification Advances, and Efficient Tech Transfer.
Novel Therapeutic Modalities
AI for QbD and Supply Chain Risk
AI in Process Verification & Antibody Design
Continuous & Integrated Processing
Royale International are logistics specialists in handling sensitive, temperature-controlled products and deliver with extreme care and precision, all across the globe. The Life Sciences Division manages a wide range of temperature-controlled shipments for various sectors such as; pharmaceuticals, healthcare, biotech, medical devices, cell & gene therapy, clinical trials, and R&D. Royale International provides premium & customized logistics solutions via On-Board Couriers & Express freight and provides quality packaging solutions so that products are safely transported to its destination. All procedures are Customs Authority, Good Distribution Practice (GDP) and International Air Transport Association (IATA) compliant, ensuring shipments safely arrive at the right place, at the right time.
ChemPartner is science-based, technology driven global CRO/CDMO research innovation engine with a broad portfolio of services spanning discovery, development, and manufacturing in both small and large molecule therapeutics, including discovery chemistry, biology, pharmacology, DMPK, and exploratory toxicology as well as biologics discovery, development, and CMC.
As a global partner to the biopharmaceutical industry, Asahi Kasei Bioprocess helps biologics manufacturers safely and efficiently produce medicines that patients can trust, by dependably supplying innovative yet exceptionally reliable bioprocess consumables, equipment, and scientific support services.
Our portfolio is anchored by Planova™ virus removal filters. First released in 1989 as the world's first hollow fiber filter developed specifically for removing viruses from biotherapeutic drug products, Planova™ filters ensure the viral safety of biopharmaceutical drug products, thanks to their high quality and consistent performance. Leveraging more than 30 years of experience, we continue to provide our customers with products, services, and expertise to achieve assurance that is beyond expectation.
ABOUT CHIME BIOLOGICS
Chime Biologics, a China-based, world-class Contract Development and Manufacturing Organization (CDMO), providing customer-centric and cost-effective services for timely premier-quality biopharmaceutical development and manufacturing. We provide one stop comprehensive solution supporting our customers from early-stage biopharmaceutical development through late-stage clinical and commercial manufacturing, catering to the evolving needs of the dynamic biopharmaceutical industry. We pledge to make world-class biopharmaceuticals affordable and accessible to all patients globally through manufacturing innovation, and empowering therapeutic advancement for improvement of human health.
With our State-of-the-art facility and in-house world class expert team, we are committed for excellence upholding highest degree of integrity. We are ISO 14001:2015 and ISO 45001:2018 certified. Our World’s first GE KuBio facility is located at Wuhan’s BioLake biotech industry development zone of China, with clear path to expand the total capacity up to 140,000+ in the near future.
Phone:+86 27 8787 9208
Asahi Kasei Bioprocess is the established global market leader in virus filtration products, with its Planova virus removal filters having an unrivalled 30 years history of trusted use in the production of biotherapeutics, such as biopharmaceuticals and plasma derived drug products.
For more info, please check: www.ak-bio.com
Pall Corporation provides critical filtration, separation, and purification solutions to meet the demanding needs of a broad spectrum of life sciences and industrial customers around the globe. Across 80 locations and 10,000 people worldwide, we are unified by a singular drive: to solve our customers' biggest fluid management challenges. And in doing so advance health, safety, and environmentally responsible technologies. Together, our Life Sciences and Industrial teams serve a diverse range of customers including biotechnology, pharmaceutical, medical, food and beverage, laboratory, microelectronics, aerospace, fuels, petrochemical, chemical, automotive and power generation industries. Our industry-leading technologies and solutions are at work in countless applications, protecting critical operating assets, improving product quality, safeguarding the health, and minimizing emissions and waste
For more info, please check: https://www.pall.com/en/biotech.html
Abzena is a leading contract provider of integrated discovery, development and manufacturing services for biologics and antibody drug conjugates (ADCs). Abzena provides the most complete set of solutions in integrated early discovery to mid-phase biotherapeutic and bioconjugation drug development and manufacturing in the biopharmaceutical industry. The company maintains resources around the world, with facilities in the US and UK. Abzena is owned by Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors. For more information, please see www.abzena.com.
Catalent Biologics has 20+ years’ experience in development, manufacturing, and analytical services for new biological entities, gene therapies, biosimilars, and antibody-drug conjugates. Catalent Biologics has worked with 600+ mAbs and 80+ proteins, with 12 marketed products using GPEx® cell line engineering technology, 25+ commercially-approved products through fill/finish and 40+ active clinical and commercial gene therapy programs.
With tailored solutions for clinical through commercial supply, Catalent Biologics brings better biologic treatments to patients, faster.
- Catalent Biologics’ capabilities include:
- GPEx® technology
- SMARTag® bioconjugation technology
- Industry-leading expertise in AAV vectors, next-generation vaccines and oncolytic virus production
- State-of-the-art biomanufacturing facilities
- Stand-alone and integrated analytical services
- Award-winning fill/finish facilities
For more information, please visit: https://biologics.catalent.com/