Continuous Manufacturing Processes For Biotechnological Products
Online MasterClass 16-17 June, 2021 Continuous Manufacturing Processes for Biotechnological Products MasterClass Mylene Talabardon Hervé Broly KEY TAKEAWAYS: Setting-up the context of the bioindustry leading to develop and implement new manufacturing technologies for recombinant proteins Understand the upstream and downstream manufacturing technologies, past, present and future, their respective benefits and drawbacks Propose methods to build up a continuous process Understand the benefits of applying continuous manufacturing (regulatory flexibility, manufacturing flexibility, productivity and economics) Understand the regulatory expectations on continuous manufacturing (ICH Q13) What are the challenges? Learn the specificities of continuous manufacturing when considering its validation Understand how to set-up a control strategy for continuous processes www.glceurope.com
Continuous Manufacturing Processes for Biotechnological Products MasterClass 16-17 June, 2021 Online MasterClass TRAINING OVERVIEW The environment for recombinant proteins used as biotherapeutics is changing. In the context of developing new biological entities, the bioindustry should further improve speed to clinic, gain in manufacturing flexibility while reducing costs of good sales (COGS). Despite at start of the recombinant era in the 80s/90s, continuous upstream processes have been applied especially for sensitive molecules such as hormones, cytokines and blood factors, the development of monoclonal antibodies as drugs was mainly based on large-scale fed-batch upstream connected to chromatography-based purification operated in batch. However, since the last ten years, it seems that the productivity of manufacturing processes of recombinant proteins based on large-scale fed-batch and classical chromatography processes has reached a plateau. As new technologies in cell separation and automatization of chromatographybased processes emerged, continuous manufacturing becomes a valid option for improving manufacturing productivity, flexibility and COGS. Whereas continuous manufacturing is now well considered for small molecules, it is not yet the case for biologics. Despite, some challenges still exist in applying continuous manufacturing processing for biologics, that approach could address some of the current limitations of largescale fed-batch processes. Who Should Attend? Big, media and small size pharma companies, medical device companies, biopharma companies from all around Europe. Process development scientists and managers CMC development program managers Manufacturing managers QC and stability control managers Heads of Quality Assurance Drug Regulatory Affairs managers www.glceurope.com booking@glceurope.com 36 1 848 0515
Continuous Manufacturing Processes for Biotechnological Products MasterClass 16-17 June, 2021 Online MasterClass Meet the Trainer: Hervé Broly Starting with an engineering degree in agriculture, followed by a PhD in plant physiology, I joined the Blood Transfusion Center (Lille, France) in 1982 where I implemented a unit for the development and manufacture of monoclonal antibodies against blood groups, blood proteins and viral antigens. In 1991, I took the position of Head of Process Development and Manufacturing at Sorebio (Martillac, France), a contract manufacturing organization specialized in the development and manufacture of monoclonal antibodies for clinical development. I took the lead of that company in 1998 after it was bought by Serono, a Swiss biotech company (Geneva, Switzerland) in 1994. In 2003, I moved to Serono in Geneva as Global Product Team Leader in charge of managing the development of a recombinant Ig-fusion protein for the treatment of autoimmune diseases, moving that product from Phase I to Phase III. As of November 2006, I’ve been appointed Vice-President, Head of Biotech Process Sciences at Merck-Serono, based in Vevey, Switzerland, in charge of developing and validating the manufacturing processes for biotechnological products. In that context, whereas Serono was mainly using perfusion processes for recombinant hormones and cytokines, we moved the company to large-scale manufacture of monoclonal antibodies using proprietary chemically-defined cell culture media and feeds. After our participation to the FDA’s pilot program on Quality by Design, the concepts described in ICH Q8(R2) and ICH Q11 were implemented in our approach to gain process understanding. It was concluded by issuing a modernized approach for process validation at Merck (Darmstadt, Germany). More recently, we have introduced advanced processes such as intensified fed-batch and continuous downstream processing. Meet the Trainer: Myléne Talabardon With over 20 years of experience in the pharmaceutical industry, Mylène has a strong experience in process development, technology transfer and process validation. She obtained her PhD in biotechnology from The Ohio State University and her environmental engineering degree from the Swiss Federal Institute of Technology (EPFL). In 2001, she joined BiogenIdec in cell culture process department, focusing on antibody production from lab scale to manufacturing scale. In 2004, she has been appointed head of cell culture department at Merck Serono and started working in validation according to QbD for biotech products. After 2 years as CMC lead for a biosimilar product, she was nominated Process Validation Expert, and in this position, she developed the Global Process Validation strategy for the company according to European and FDA regulations for pharmaceuticals, and supported CMC teams in developing Process Validation plans for new biologics as well as for legacy products. www.glceurope.com booking@glceurope.com 36 1 848 0515
Continuous Manufacturing Processes for Biotechnological Products MasterClass 16-17 June, 2021 Online MasterClass day1 08:50 day2 Connecting to the online MasterClass 09:00 Welcome and introduction 09:15 Context 09:45 Connecting to the online MasterClass 09:00 Current technologies for producing large amounts of recombinant proteins Need for manufacturing flexibility Pressure on manufacturing costs Single-use systems Regulatory expectations 10:30 ICH Q13 Steady state vs State-of-Control Diversion points Limitations for biotechnological processes Process Analytical Technologies Break Upstream Perfusion Technologies 10:45 Principles (batch, fed-batch, Intensified fed-batch and perfusion) Cell metabolism in fed-batch vs perfusion Cell retention devices Continuous buffer feed 10:45 Process validation for continuous processes Break 11:00 Downstream Technologies 12:30 08:50 END Principles of “continuous” chromatography Available technologies based on chromatography resins Continuous viral inactivation End of Day 1 Control Strategy Residence time distribution Continuous viral clearance Continuous filtration Bioburden control 11:45 The future of continuous processing 12:15 Questions and answers 12:30 Evaluation Session 12:45 END New purification technologies Economics Process Analytical Technologies Real-Time Release End of Day 2 All dates and times are expressed in UTC/GMT 1 on the Agenda. www.glceurope.com booking@glceurope.com 36 1 848 0515
Continuous Manufacturing Processes for Biotechnological Products MasterClass 16-17 June, 2021 Online MasterClass Upcoming Events About GLC FINANCIAL EVENTS Advanced Risk Based Audi ng MasterClass May 2021 Advanced Risk Based Pricing MasterClass May 2021 Stress Tes ng MasterClass May 2021 FinTech M&A MasterClass May 2021 9th Annual Retail and Corporate Payments Forum (BizzPay 9.0) May 2021 Global Leading Conferences (GLC) is an industry leader in the field of business intelligence. We provide interactive & impactful business platforms and networking opportunities for senior level executives by bringing them together for B2B Conferences, Global Summits, Training & Workshops. Being customer focused and having our client’s priorities at the forefront, are amongst our core values and is of high importance to the way we operate our business. Our passion for customer satisfaction and results, drive us to work with industry experts closely - who fully understand their peers interests and day-to-day challenges - in order to deliver the most impactful events. We are specialized in industries such as; Pharmaceutical, Banking & Finance, Energy, Oil & Gas, IT & Communication, Sales & Marketing, Law and Human Resources. Our commitment is to deliver the latest information to our clients, while maintaining highest quality and standards. By attending GLC events your company will be able to apply advanced strategies to your operations, gain the latest knowhow’s and benchmark yourself higher against the competition while enjoying a 5 star environment. PHARMACEUTICAL EVENTS Pharma Real-World Evidence MasterClass March 2021 Medical Device Regula on MasterClass March 2021 Regulatory and quality requirements for the design and April 2021 development of Medical Device So ware MasterClass Analy cal Chemistry for Non Analy cal Chemists MasterClass May 2021 Process Valida on for Biotechnological Products MasterClass May 2021 Development of generics: From R&D to GMP MasterClass May 2021 Smart Packaging & Technical Opera ons in Pharma MasterClass May 2021 GXP in Pharma MasterClass May 2021 Analysing and Dra ing Commercial Contracts in Life Sciences May 2021 GLC’s Custom In-House Trainings MasterClass Advanced CMC MasterClass May 2021 Risk Based Valida on of Laboratory Computerised Systems May 2021 MasterClass Best Prac ces and Tools for Pharma Project Management May 2021 MasterClass Pharma Cybersecurity Risk Management and Audit MasterClass May 2021 Benefit-Risk Assessment in Pharmacovigilance MasterClass May 2021 Con nuous Manufacturing Processes for Biotechnological TBA What is it? No travel or logistic expenses for the team (we deliver it at your facilities) Maximize ROI with a depth tailored content accordingly to your corporate needs 360 degrees GLC Learning experience – Individual pre-questionnaire for each participant, several case studies and post training diagnose with participants Maturity assessment for the team during the preparation of the course Products MasterClass 6th Annual Pharma Pricing & Reimbursement Forum May 2021 HUMAN RESOURCES EVENTS Contact us for more information and tailored details: Talent Development in Remote Working MasterClass March 2021 Sales Incen ve Plans MasterClass May 2021 Learning & Development to a ract and retain talent MasterClass May 2021 booking@glceurope.com Media Partners CROSS INDUSTRY EVENTS C#/ML.NET Machine Learning MasterClass May 2021 Women in Leadership MasterClass May 2021 Sales Incen ve Plans MasterClass May 2021 Leadership in Safety Virtual Workshop May 2021 Turnaround and Shutdown Management MasterClass May 2021 www.glceurope.com booking@glceurope.com 36 1 848 0515
Continuous Manufacturing Processes for Biotechnological Products MasterClass www.glceurope.com boongglceurope.com une nlne Maerla day1 day2 10:45 Break 10:30 Break 08:50 Connecting to the online MasterClass 08:50 Connecting to the online MasterClass 12:30 END End of Day 1 12:45 END End of Day 2 11:00 11:45
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