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Biomanufacturing Digital Half Day Workshop

Advances in Convergent Bioprocessing: Case Studies from the Intersection of Novel Process and Digital Technologies.

Wed, June 10, 2020 09:00 AM - 12.00 PM EDT

Merck KGaA, Darmstadt, Germany invites you to the Biomanufacturing Virtual Workshop

Achieving greater efficiency, productivity, and product quality requires a new perspective that breaks across silos, unit operations, and specific disciplines in biomanufacturing. The application of Industry 4.0 principles in biomanufacturing enable innovative, digital technologies and approaches to merge with intensified process technologies to create a phenomenon we call convergent bioprocessing or Bioprocessing 4.0. With connected and continuous processing on the horizon, the implementation of these new technologies in upstream, downstream, data analytics, and automation will be examined in a series of application and case studies, cost analyses, and new technology presentations. Come witness how these convergent technologies are creating a single environment for a paradigm shift and digital transformation in biomanufacturing. 

  • Michael Felo, Director, Integrated Solutions Marketing – BioContinuum™ Platform

  • Lénaïg Savary, MSAT Upstream biomanufacturing Engineer

  • Jeffrey Barna, Research Scientist

  • Hemant Garg, Product Manager Analytics

  • Aniruddha Bose, Global Product Manager

  • Andrew Carass, Associate Director – Technology Management

  • Sandeep Mora, Head of Next Generation Downstream Process R&D

  • Michael Felo has 20 years of biopharma industry experience, has held positions in recombinant protein and monoclonal antibody downstream process development, clinical phase production, and technology transfer. Most recently, Mike was responsibility for the management of Mobius® single use solutions and is now Director of downstream process integration within the Next Generation Processing group, focusing on intensified, connected, and continuous purification technologies. Mike has a bachelor’s degree in chemical engineering and a master’s degree in biotechnology, both from the University of Pennsylvania.

  • Lénaïg Savary has more than 12 years of experience in the pharma and biotech industry. She started her career has a process engineer at Sanofi Pasteur (Swiftwater, US) working on adjuvants for vaccines. She has been with Merck (previously Millipore) for more than 10 years. She provides technical support to EMEA customers on single-use bioreactors, as well as single-use and multi-use mixers. Lénaïg holds a Master Degree in Process Engineering from the Engineering School ENSIC (Nancy, France) as well as a Master Degree in Marine Biotechnology from the University of Nantes (France).

  • Jeffrey Barna is a Research Scientist working in the downstream process development team in the BioContinuum Platform Application and Innovation group.  Since joining MilliporeSigma in 2014, he has worked extensively in capture and polishing chromatography, with protein A being a primary focus.  Through his role in the BioContinuum group, he has gained expertise in process modeling of both the upstream and downstream.  Jeffrey holds a B.S. in Chemical Engineering from the University of Connecticut, and is currently pursuing a Masters’s degree in Biotechnology from Johns Hopkins University.

  • Hemant Garg is on a digital mission to help biopharmaceutical industries grow and evolve in data analytics world. Trained as business analytics engineer, he has 13 years professional experience working across multiple roles within biopharma manufacturing industries. He holds expertise in driving complex industry research, long term forecasts, data analytics and modelling processes to identify, create & capitalize on unmet market needs. His deep understanding of statistical and predictive modelling concepts has helped his organization transforming it’s products and services into client focused analytics platform. At Merck life sciences, Hemant is leading the efforts in strategizing and launch of digital & analytics products for biopharmaceutical customers.

  • Aniruddha Bose is a passionate marketer with 13 years of experience in India and Global Biotechnology markets with a focus on Bioprocessing and Biomanufacturing. Aniruddha handled molecules screening and Process Development Projects for Biomolecules in Biocon. Later moved into Business Development, Field Marketing & Application Support in GE Life Sciences (Cytiva). Postgraduate in Biotechnology from Vellore Institute of Technology, one of the most reputed institution in India, Aniruddha finds lots of interest in product and process related workstreams.

  • Andrew Carass is an Associate Director within the Technology Management group of MilliporeSigma where he is responsible for supporting customers with the adoption and implementation of MilliporeSigma technologies. Prior to his role at Merck he worked for SAFC, Sartorius Stedim & FUJIFILM Diosynth Bio­technologies (then Avecia Biotechnology). Andrew hold a BSc in Pharmacology from the University of Leeds (UK) and an Executive MBA from the University of Bradford (UK).

  • Sandeep Mora leads the BioContinuum™ Platform downstream process development team focusing on integrated processing solutions for downstream mAb purification. His expertise includes process development and automation, and scale-up and scale-down of embedded systems. Sandeep holds a Ph.D. in Chemical Engineering from the Georgia Institute of Technology.      

9:00 – 9:05

Welcome and introduction

Michael Felo, Director, Integrated Solutions Marketing – BioContinuum™ Platform

9:05 – 9:30

Novel Cell Retention Device and System for N-1 Perfusion Processes

Lénaïg Savary, MSAT Upstream Biomanufacturing Engineer

  • Perfusion processes are becoming a more viable alternative to expand performance beyond what traditional batch/fed-batch platforms can attain.
  • Presentation of the benefits of using a family of pre-sterilized, high-throughput perfusion filtration solutions/systems.
  • Presentation of data in an N-1 perfusion application along with demonstrated scalability from the 3 L to 50 L scale.

9:30 – 09:55

A Cost Analysis and Evaluation of Perfused Seed Train Scenarios Through Process Modeling

Jeffrey Barna, Research Scientist

  • Several different variations of perfused seed trains were modeled
  • Potential benefits found from using High Seed Fed Batch production over Traditional production
  • The impact of multiple bioreactors and various production/seed train ratios were explored

09:55 – 10:05


10:05 – 10:30

Innovative Next-Generation Monitoring of Bioprocessing to Enable Smart Data Management and Analysis

Hemant Garg, Product Manager Analytics

  • Overview of Bioprocess life cycle
  • Challenges in existing Bioprocess data landscape – multiple disparate systems & Investigations
  • Introduction to Data management & analytics software offering from Merck Millipore – Key benefits & salient features

10.30 – 10:55

Orchestrating bioprocesses in present manufacturing facilities

Aniruddha Bose, Global Product Manager

  • Our solution offers a centralized management and visualization of regulatory-compliant Biomanufacturing systems. The solution is enabled by browser-based access to users, data collection, recipes, reports, and alarms in a holistic, process focused way
  • Our modular approach caters to specific Automation needs of the Biopharma manufacturing
  • Our solution is Intuitive UI, Light on deployments. The Modular strategies are curated to cater the customers’ growing needs

10:55 – 11:05


11:05 – 11:30

Intensified Buffer Management as a Strategy for Increased Manufacturing Efficiency

Andrew Carass, Associate Director – Technology Management

  • Impact of intensified processing on buffer consumption in monoclonal antibody manufacturing
  • Review buffer management strategies to address facility bottlenecks, increase facility throughput and reduce cost
  • Assessment of components required to successfully implement buffer dilution

11:30 – 11:55

Flow-Through Polishing Process Development: A Holistic Approach

Sandeep Mora, Head of Next Generation Downstream Process R&D

  • An integrated flow-through polishing technology platform for mAb purification was studied thoroughly.
  • Commercially available and novel prototype chemistries and devises such as activated carbon, Eshmuno Q Resin, Eshmuno CP-FT were investigated.
  • A design of flow-through polishing train that can meet the stringent demands expected for mAb polishing purification is proposed.

11:55 – 12:00

Wrapping up & Thank you

Michael Felo, Director, Integrated Solutions Marketing – BioContinuum™ Platform

Inhalation & Respiratory Drug Delivery Webinars

Inhaled Targeted-Inhibition Of Galectin-3 Dose Dependently Blocks Plasma Biomarkers In Patients With Idiopathic Pulmonary Fibrosis

Tue, Mar 3, 2020 2:00 PM - 3:00 PM GMT

Presented by Tariq Sethi, Co-Founder, Galacto Biotech and Former Chief Scientist Vice President Clinical Development Unit, AstraZeneca

Hosted by Tariq Sethi, Co-Founder, Galacto Biotech and Former Chief Scientist Vice President Clinical Development Unit, AstraZeneca

  • Galectin-3 is a key regulator of fibrosis
  • TD-139 is a specific Galectin-3 inhibitor formulated for inhaled treatment 
  • TD139 is safe and well tolerated in man
  • TD-139 demonstrated dose dependent target engagement 
  • TD-139 specifically decreases in plasma biomarkers associated with IPF progression 
  • Suggesting inhaled TD-139 is a potential novel therapy for IPF 

Our complimentary webinar is for respiratory and inhalation experts interested in learning more about the latest innovations in inhaled therapies. This is a free event open to all, so why not register and benefit from the expertise of our speakers?

Professor Tariq Sethi is Chief Physician Scientist, Vice President AstraZeneca and Emeritus Professor of Respiratory Medicine Kings College London. He was previous head of the Respiratory Immunology Autoimmunity Translational Medicine Unit.  Prior to joining AZ he was Head of Respiratory Medicine at Guy’s, St. Thomas’ and King’s College Hospital NHS Foundation Trusts and Professor of Respiratory Medicine King’s College London and formally Professor at the University of Edinburgh. He was educated at Cambridge and London Universities followed by hospital jobs in London. He did a Ph.D at the Imperial Cancer Research Fund London, was an MRC Travelling Fellow at the Scripps Research Institute California and a Wellcome Trust Senior Research Leave Fellow in Edinburgh. His research interests focus on the interaction between inflammation and lung cancer, Prof. Sethi continues on the editorial board of THORAX and was formally a member of the Population Systems Medicine Board Medical Research Council UK, Chair of Asthma (UK) and member of the British Lung Foundation Scientific Committees. He is also a Co-Founder of Galecto Biotech

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