Modern Approaches to Process Understanding
|
|
- Noah Montgomery
- 6 years ago
- Views:
Transcription
1 Biomanufacturing and Process Development (BPD) Modern Approaches to Process Understanding Thursday, September 18, :00 pm - Registration begins 1:15 5:00 pm - Presentations & Networking North Carolina Biotechnology Center Program Organizers: Barney Crum, barney.crum@roche.com Gary Gilleskie, gary_gilleskie@ncsu.edu EVENT SPONSORED BY
2
3 AGENDA 1:00 1:15 pm Registration 1:15 1:30 pm Introductory Comments How Today s Expectations and Tools for Process Understanding Differ from 10 Years Ago Gary Gilleskie, North Carolina State University 1:30 2:10 pm In Situ Monitoring of Cell Culture Exit-gases Through Novel Process Analytical Technology Kevin Chang, Biogen Idec 2:10 2:50 pm Accelerating Cell Culture Process Development Shahid Rameez, KBI Biopharma 2:50 3:30 pm Networking 3:30 4:10 pm Quality By Design and the Use of DOE as a Right First Time Approach to Process Development and Risk Reduction in Downstream Manufacturing Mark Wilson, Novartis Vaccines and Diagnostics 4:10 4:50 pm "High Throughput Analytics to Enhance Efficiency and Economics in Bioprocessing Yixin Lin, Pall ForteBio, LLC 4:50 5:00 pm Closing comments
4 ABSTRACTS Kevin Chang Engineer II (Pilot Plant Cell Culture in Cambridge) Biogen Idec In Situ Monitoring of Cell Culture Exit-gases Through Novel Process Analytical Technology" Abstract: Biogen IDEC (BIIB) is focusing on designing and developing new state of the art technologies that will enable real-time process control aiding advanced control algorithms that generate company value by increasing productivity, process consistency, and product quality to internal programs. One of the BIIB Advanced Process Control (APC) projects is evaluating the novel way of collecting cell culture off-gas. The off-gas from the bioreactor has been an undefined area in the biotechnology industry due to complexity and lack of advanced technologies. Current process analytical technologies mostly focus on liquid-phase components such as glucose, lactate, cell density, and titer. However, the gas-phase components from the bioreactor can be very important in terms of scale-up, feed strategies, and biomass. The FDAs mandate on process analytical technology improvements in bioprocessing makes this an obvious application area that should be explored. Optograf analyzer presents an innovative way of using spectroscopy to measure the composition of exhaust gasses associated with bioprocessing, creating a complete mass balance around the system. It is a more robust offgas PAT tool than the traditional electrochemical sensor gas analyzer. In terms of operation, Airhead probe from the Optograf analyzer (Kaiser Optical Systems, Inc.) is easier to implement as the associated probes are simply placed in the bioprocess gas lines and eliminate the requirement for sensor/membrane replacement and complicated calibration protocols associated with traditional off-gas analyzers. Optograf uses the technology of Raman spectroscopy which is a form of infrared vibrational spectroscopy with theoretical basis described by the shift in energy levels of molecular bonds upon excitation from a higher energy source. The Optograf will not only lead to more precise calculations of the Oxygen Uptake Rate (OUR) and Carbon Dioxide Production Rate (CPR) by measuring the differences of sparge and exhaust oxygen and carbon dioxide, but may also be able to track unknown off-gas species which will unravel a novel field in mammalian cell culture. Bio: Kevin received a BS in chemical engineering from the University of California, San Diego. He has worked at Biogen Idec for about 6 years, focusing on the area of cell culture. He began his career at Biogen Idec in small-scale cell culture, working on developing chemically defined media for high titer processes. He later joined the pilot plant cell culture group, where he supports manufacturing scale up and the use of advanced process control technologies.
5 ABSTRACTS Shahid Rameez, Ph.D. Senior Process Development Scientist KBI Biopharma Inc. Accelerating Cell Culture Process Development" Abstract: Decreasing the timeframe for cell culture process development has been a key goal towards accelerating biopharmaceutical development. The data presented here will help to demonstrate the utility of high throughput miniaturized bioreactor system (ambr) in accelerating cell culture process development. Through various case studies conducted at KBI Biopharma we will demonstrate on how these high throughput bioreactors are used to study effects of various process parameters on cell growth, productivity and product quality. In addition, we will present some case studies demonstrating incorporation of these bioreactors to study optimization of process design space and effect of process control perturbations. Bio: Shahid is a process development team leader at KBI Biopharma Inc. As a team lead he works on all the CMC activities responsible for developing cell culture processes (inhouse and for the clients). Shahid's expertise is in scale-up/scale-down, technology transfer, high-throughput cell culture development and analytics. Shahid Rameez received his PhD in Biochemistry program (Department of Chemical Engineering) from The Ohio State University in Prior to joining KBI in 2012, he was a Postdoctoral Research Fellow in the Department of Chemical Engineering at The Ohio State University. Shahid has over 8 publications in the area of protein therapeutics and process development.
6 ABSTRACTS Mark Wilson, Ph.D. Senior Manager, Downstream Technical Development Novartis Vaccines and Diagnostics Quality By Design and the Use of DOE as a Right First Time Approach to Process Development and Risk Reduction in Downstream Manufacturing Abstract: Quality by Design and the Use of DOE as a Right First Time Approach to Process Development and Risk Reduction in Downstream Manufacturing: QbD is an ICH initiative that Regulatory Authorities expect to be used by industry in drug development This presentation seeks to explain what QbD means at Novartis and how we implement it What does it mean to the science and what experiments do we need to do? Finding out about interacting factors and building the design space is a key part of QbD What is Design Space and how do we develop it? Case studies in the use of statistical design are presented QbD and DoE are used from the outset in screening studies, throughout the lifecycle and into commercial manufacture The knowledge and understanding gained is a sound foundation for robust, reliable manufacture with reduced risk Bio: Mark Wilson has worked in biotech process development for over 25 years. He has experience working at small biotech and large pharma companies, and with products as diverse as live virus vaccines, protein sub-unit vaccines, therapeutic proteins and antibodies. His experience spans the project lifecycle from Research to Launch. Mark has been using Design of Experiments since 1998 and has seen the gradual progression of Quality by Design over the last decade to where it is now an expectation of the Regulatory Authorities. Mark is an advocate of ensuring that Development provides a robust, reliable process to Manufacturing that delivers high quality product to the patient with minimal risk of batch failure. Mark holds a BS and PhD from University of Kent and subsequently worked for 20 years in the UK. Mark moved to the US in 2009 and now works at Novartis Vaccines as Senior Manager, Downstream Technical Development.
7 ABSTRACTS Yixin Lin, Ph.D. Technical Support Scientist Pall ForteBio, LLC High Throughput Analytics to Enhance Efficiency and Economics in Bioprocessing Abstract: To address the needs of a large number of biotherapeutic molecules and vaccines in development, it has become increasingly important for biopharmaceutical companies to adopt a new generation of high throughput (HT) analytical techniques to facilitate fast and accurate characterization and processing monitoring. Recent advances in the use of Bio-layer Interferometry (BLI) are described for monitoring biotherapeutic molecules through quantitation and functional characterization, with emphasis on new development/methods in bioprocessing. The approaches offer benefits of label-free, real-time monitoring, enhanced throughput, decreased sample preparation requirements, and low cost of operation. Bio: Yixin Lin is a technical scientist from Pall ForteBio, LLC. Yixin has been with Pall ForteBio for 4 years. Previously she worked as a field application scientist in various life science companies for more than 10 years. She holds a Ph.D. degree from Cornell University in biochemistry and has just recently moved to North Carolina from New York State.
8 Notes
9 Notes
10 Program Schedule Season Month September 18, 2014 Program PAT/QbD Symposium Modern Approaches to Process understanding (upstream and downstream ) NC Biotechnology Center October 23, 2014 November 13, 2014 January 2015 February 19, 2015 (Feb 24 snow day) March 10, 2015 April 11, 2015 April 16, 2015 May 14, 2015 Continuous Process Symposium NC Biotechnology Center Analytical Symposium & Vendor Show (Drug Product Theme Formulation, Devices, Analytical Testing or Analytical / Formulations - could include CROs) NC Biotechnology Center Manufacturing Facility Tour Date and location TBD Single Use Symposium & Vendor Show NC Biotechnology Center 22nd Annual ISPE-CaSA Life Sciences Technology Conference Raleigh Convention Center 500 S. Salisbury Street, Raleigh, NC (sponsorships available through ISPE Early-Bird Exhibitor Deposit Form) Triangle SciTech Expo (aka Best Fest ) NC Museum of Natural Sciences 11 W Jones St, Raleigh, NC Quality/Regulatory Symposium NC Biotechnology Center New Frontiers Symposium and Expo NC Biotechnology Center **Monthly Meeting and Vendor Sponsorship Packages available, request information**
11 Biomanufacturing & Process Development Group An Intellectual Exchange Group of the North Carolina Biotechnology Center Mission and Goals BPD s mission is to provide a forum for process development scientists and engineers to discuss bioprocessing issues. The group meets approximately six to seven times a season/year with speakers from academia, industry, technology vendor experts, and regulatory experts. Membership Guidelines Faculty, students, postdocs and industry members with interest in BPD are welcome. Meeting Format Similar meeting format as previous years will be maintained in the season. Each event will host multiple speakers centered around the event theme, allow a time for networking among attendees, and optionally include a vendor show or poster presentations. Sponsorships Monthly meeting and vendor sponsorship packages available. Please contact Brian Nunnally, Brian.Nunnally@biogenidec.com at or Dhaval Tapiawala, dhaval.tapiawala@fujifilmdb.com at for additional information. For More Information Brad Kosiba, BK Collaborative, LLC brad.kosiba@bkcollaborative.com Cricket Megarity, Pfizer Christine.megarity@pfizer.com
12 EVENT SPONSORED BY
Calendar. The Clear Solution to Reach the Global Biopharma Audience. INTERNATIONAL
The Clear Solution to Reach the Global Biopharma Audience yvdavyd/getty Images & blackred/e+/getty Images 2017 EDITOrial Calendar Editorial Coverage Special Themed Issues January Biopharma Outlook for
More informationPRELIMINARY AGENDA ** Attendees must already be registered to attend cphi Japan conference**
PRELIMINARY AGENDA ** Attendees must already be registered to attend cphi Japan conference** The Future of Biologics Development and Manufacturing 20 April 2017 13:00 16:00 Big Sight Exhibition Center,
More informationKupers Luc IMI webinar
Biomanufacturing 2020 (biomfg2020): Development of Innovative high throughput analytical tools and methods to characterize cell culture fluid during development and commercial cell culture processes Kupers
More informationProCellics. In-Line & Real-Time Bioprocess Raman Analyzer
ProCellics is the first GMP Bioprocess Raman Analyzer for the biopharmaceutical industry fully dedicated to in-line monitoring of the critical parameters and quality attributes in real-time, in order to
More informationSpeakers Title & Biography
Speakers Title & Biography Dr. Janice M. Soreth Deputy Director, FDA Europe Office/CDER, Liaison to EMA Dr. Soreth 20-year agency veteran with unparalleled experience, including serving as CDER's director
More informationSummer Training Program In Industrial Biotechnology BiOZEEN, Bangalore
Summer Training Program In Industrial Biotechnology BiOZEEN, Bangalore BiOZEEN Summer Training Program in Industrial Microbiology & Fermentation Technology One small step can brighten your future Microbes
More informationA Quality-by-Design Approach to Upstream Bioprocess Interrogation and Intensification
APPLICATION NOTE No. 3 I September 215 A Quality-by-Design Approach to Upstream Bioprocess Interrogation and Intensification Stephen Craven 1 and Ulrike Becken 2 * 1 APC Ltd, Dublin, Ireland; 2 Eppendorf
More informationAmerican Association of Pharmaceutical Scientists (AAPS)
American Association of Pharmaceutical Scientists (AAPS) AAPS, King Street, Alexandria, VA, USA* he American Association of Pharmaceu- Scientists (AAPS), founded in 1986, Ttical is an individual membership
More informationPatricia Van Arnum Issue Date: February 2012 Editor Contact: Patricia Van Arnum, (732)
Pharmaceutical Technology Patricia Van Arnum Issue Date: February 2012 Editor Contact: Patricia Van Arnum, pvanarnum@advanstar.com, (732) 346-3072 Biopharmaceutical Industry in 2012: Optimism on the Rise
More informationThe State of QbD in the Biopharmaceutical Industry Conference
The State of QbD in the Biopharmaceutical Industry Conference Criticality Assessment, Design Space Implementation and Control 10 11 April 2013 Sheraton Fisherman s Wharf San Francisco, California USA Sponsored
More informationBiologics. Biologics. The Centre for Process Innovation. From innovation to commercialisation
Biologics Biologics The Centre for Process Innovation From innovation to commercialisation The Centre for Process Innovation From innovation to commercialisation The High Value Manufacturing Catapult is
More informationDevelopment from Bench to Clinic
Accelerating Novel Vaccine Development from Bench to Clinic Roger Lias. Ph.D. President Eden Biodesign, Inc Questions Questions are encouraged and can be asked by sending an email to: edenbiodesign@propelmg.com
More informationThe Biopharma Symposium: Process and Formulations by GEA-NUS PPRL & Roquette University
The Biopharma Symposium: Process and Formulations by GEA-NUS PPRL & Roquette University Monday, 3 September 2018 Time Activity 08:00 08:30 Registration 08:30 09:00 Welcome address 09:00 09:50 Biopharmaceutical
More informationSEEING THE FUTURE A REVIEW OF THE ISPE 2016 FACILITY OF THE FUTURE CONFERENCE. Phil McDuff VP Global Engineering Biogen
SEEING THE FUTURE A REVIEW OF THE ISPE 2016 FACILITY OF THE FUTURE CONFERENCE Phil McDuff VP Global Engineering Biogen Robert Chew President & CEO Commissioning Agents Inc. Jim McGlade Client Leader BHDP
More informationImplementing New Technologies in Bioprocessing Howard L. Levine, Ph.D.
Implementing New Technologies in Bioprocessing Howard L. Levine, Ph.D. Presented at: AGC Biologics 2018 Global CMO Consultant Summit September 10-13, 2018 Seattle, WA BioProcess Technology Consultants,
More informationCareer Growth Areas in Physiology / Pharmacology
Career Growth Areas in Physiology / Pharmacology Magdalena Alonso-Galicia, PhD Pharmacology Department Forest Research Institute, Inc. Jersey City, NJ 1 Career Growth Areas in BioPharma n Pharmaceutical
More informationQbD Concepts Applied to Qualification and Transfer of Analytical Methods
QbD Concepts Applied to Qualification and Transfer of Analytical Methods CMC Strategy Forum Latin America - 2014 Patrick Swann Senior Director Technical Development QbD = Quality by Design QbD - A systematic
More informationIndia as an Outsourcing Frontier in Biotechnology
1 India as an Outsourcing Frontier in Biotechnology K.V. Subramaniam President & CEO 3 rd Annual Biotech Supply Chain Academy Conference San Francisco Oct 26, 2010 Biotechnology Industry Issues Long gestation
More information2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges Thursday, May 9 Registration Open Continental Breakfast
2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges End-to-End Product Development Manufacturing, Supply, and Quality May 9-10, 2019 Hilton Long Beach Long Beach, CA As
More information2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges Thursday, May 9 Registration Open Continental Breakfast
2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges End-to-End Product Development Manufacturing, Supply, and Quality May 9-10, 2019 Hilton Long Beach Long Beach, CA As
More informationA Roadmap to Biomanufacturing
MASSACHUSETTS INSTITUTE OF TECHNOLOGY A Roadmap to Biomanufacturing INTRODUCTION Join us in Principles of Biomanufacturing: Using Biotechnology to Manufacture Medicines and earn 3 CEUs and a MIT Professional
More informationRE-SHOWING: Continuous Manufacturing of Biopharmaceuticals
ISPE Boston Area Chapter Presents: RE-SHOWING: Continuous Manufacturing of Biopharmaceuticals Thursday, March 30, 2017 5:30 pm to 8:30 pm RE-SHOWING OF MARCH 16 th PROGRAM AT THANK YOU TO OUR PROGRAM SPONSOR
More informationFast Trak Services: Ongoing collaboration aims to accelerate biosimilar approval in China
GE Healthcare Fast Trak Services: Ongoing collaboration aims to accelerate biosimilar approval in China A case study Fast Trak Services Ongoing collaboration aims to accelerate biosimilar approval in China
More informationRegulatory Considerations on. Office of Biotechnology Products
Regulatory Considerations on Multiproduct t Facilities for Biotechnology Products Jun Park, Ph.D. Division of Monoclonal Antibodies Office of Biotechnology Products OPS/CDER/FDA 2011 CASSS CMC Strategy
More informationContinuous Biomanufacturing: Relevant Experiences with Development, Hybrid Implementation, and Emerging Opportunities
Continuous Biomanufacturing: Relevant Experiences with Development, Hybrid Implementation, and Emerging Opportunities Erik Fouts, Ph.D. VP and Site Head, Novato Operations 3-4 December ASTM E2968 14 Continuous
More informationProtein Formulation Development Summit
Summit Register by August 10th and Save up to $200. See page 6 for details! Accelerating your protein therapeutic through analytical characterization, formulation development, delivery device selection
More informationParadigm Change in Manufacturing Operations
Technical Report No. 54-4 Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug
More informationLFB BIOMANUFACTURING YOUR CDMO PARTNER FOR MABS AND RECOMBINANT PROTEINS B IOMANUFACTURING
YOUR CDMO PARTNER FOR MABS AND RECOMBINANT PROTEINS B IOMANUFACTURING COMMITMENT AND FLEXIBILITY LFB BIOMANUFACTURING is a medium-sized CDMO offering Bioproduction services, from an industrial facility
More informationAddressing challenges in Drug Development and Quality Control with innovative solutions
Addressing challenges in Drug Development and Quality Control with innovative solutions SYNOPSIS 16 May 2013, 9:30 am 3:00 pm Gd. Titan Centre (Theater Room) This seminar is designed for scientists in
More informationFast Trak Services: Long-term collaboration supports speed to market in single-use biomanufacturing
GE Healthcare Fast Trak Services: Long-term collaboration supports speed to market in single-use biomanufacturing A case study Fast Trak Services Long-term collaboration supports speed to market in single-use
More information2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges Thursday, May 9 Registration Open Continental Breakfast
2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges End-to-End Product Development Manufacturing, Supply, and Quality May 9-10, 2019 Hilton Long Beach Long Beach, CA As
More informationCOPYRIGHTED MATERIAL QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS. Rohin Mhatre and Anurag S. Rathore 1.1 INTRODUCTION
1 1.1 INTRODUCTION QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS Rohin Mhatre and Anurag S. Rathore The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should
More informationStability Testing for Pre-Clinical and Early Phase Clinical Drug Products
Microrite, Inc. brings you this unique learning experience in Stability Testing for Pre-Clinical and Early Phase Clinical Drug Products; Part of Microrite s step-by-step webinar series. Stability Testing
More informationPRAXIS. A publication by Bioengineering AG
PRAXIS A publication by Bioengineering AG Portrait of Rentschler Biotechnologie GmbH, a globally active service company that supports its clients in the development, production, and registration of biopharmaceuticals.
More informationTransition to Next Gen Downstream Processing to Capitalize on Growth Opportunities in High-Value Low-Volume Biologics
A Virtual Think Tank Executive Summary Transition to Next Gen Downstream Processing to Capitalize on Growth Opportunities in High-Value Low-Volume Biologics By: Unmesh Lal, Program Manager, Transformational
More informationConjugated protein biotherapeutics
B i o P r o c e s s TECHNICAL Mass Spectrometric Conjugate Characterization Process Qualification of Recombinant Protein Hapten Conjugation Miao-Fang Lin, Margo Wilson, Michael V. Murray, and Greg W. Adams
More information3rd Oral Drug Formulation Innovations June 26-27, 2019 Philadelphia, PA
3rd Oral Drug Formulation Innovations June 26-27, 2019 Philadelphia, PA Uncovering the Future of Formulation Development, Oral Drug Delivery and Innovative Strategies to Accelerate Drug Product Time-To-Market
More informationQuality by Design Considerations for Analytical Procedures and Process Control
Quality by Design Considerations for Analytical Procedures and Process Control Moheb M. Nasr, Ph.D. ONDQA/CDER/FDA IFPAC 2009 Baltimore, MD January 26, 2009 1 Outline Background on FDA Initiatives and
More informationDRIVE DOWN COSTS. IMPROVE TIMELINES. NAVIGATE THE REGULATORY LANDSCAPE.
26-28 February 2019 Hilton Tokyo Bay Tokyo, Japan DRIVE DOWN COSTS. IMPROVE TIMELINES. NAVIGATE THE REGULATORY LANDSCAPE. BioProcess Experts Help You Accelerate Biologics Development and Production Jerry
More informationRobust Data Analytics in Biopharmaceutical Manufacturing. Richard D. Braatz
Robust Data Analytics in Biopharmaceutical Manufacturing Richard D. Braatz Background: Biopharmaceuticals Manufacturing 500 Products derived from biological organisms for treating or preventing diseases
More informationA Late-Stage Monoclonal Antibody in the FDA QbD Pilot Program: Moving from Concepts to Implementation
A Late-Stage Monoclonal Antibody in the FDA QbD Pilot Program: Moving from Concepts to Implementation Ron Taticek, Ph.D., Director Pharma Technical Regulatory Genentech, Inc. South San Francisco, CA WCBP
More informationAnalytical Method Validation
National University of Singapore Academy of GxP Excellence (NUSAGE) & PharmEng Technology Presents Part of the Pharmaceutical and Biotechnology Training Courses Instructor LOH Kean Chong, Ph.D.* Senior
More informationDriving Value through Innovation in Biotech Manufacturing. Agenda
Driving Value through Innovation in Biotech Manufacturing Jorg Thommes, PhD Senior Vice President Operations Technology and Innovation Biogen 7 October 2015 Agenda Biopharma Legacy, Trends, & Challenges
More informationMedical Device Preclinical Bootcamp
Medical Device Preclinical Bootcamp March 30, 2018 9:30am - 2:30pm Massachusetts Biotechnology Council (MassBio) 300 Technology Square, 8th Floor Cambridge, MA 02139 Featured Speakers Rosalyn Año Laurence
More informationASMS Workshop Report
ASMS Workshop Report 1.Title of workshop and those presiding Title: Get Ready to Become an MS Rising Star -Young Mass Spectrometrists Workshop Presided by Olga Friese (Pfizer) and Dian Su (Genentech) 2.Date
More informationBiomanufacturing Capacity for Biosimilars: Is there enough?
Biomanufacturing Capacity for Biosimilars: Is there enough? Cambridge Healthtech Institute s Third Annual BIOAnalytical Summit 2012 Mar 19-22 Baltimore, MD BioProcess Technology Consultants www.bptc.com
More informationInvestor Overview Presentation ADVANCING LIFE SCIENCE TOGETHER
Investor Overview Presentation ADVANCING LIFE SCIENCE TOGETHER Forward-Looking Statement Disclaimer In order to take advantage of the safe harbor provisions of the private securities litigation reform
More informationFacility of the Future: Next Generation Biomanufacturing Forum
Reprinted from PHARMACEUTICAL ENGINEERING The Official Technical Magazine of ISPE March/April 2013, Vol 33, No 2 Copyright ISPE 2013 www.pharmaceuticalengineering.org facilities and equipment Facility
More informationProcess Validation. Instructor Philip K. Ngai, Ph.D.* Senior Advisor & Trainer. National University of Singapore Academy of GxP Excellence (NUSAGE)
National University of Singapore Academy of GxP Excellence (NUSAGE) & PharmEng Technology Presents Part of the Pharmaceutical and Biotechnology Training Courses Instructor Philip K. Ngai, Ph.D.* Senior
More informationThe Ever-increasing Complexity of Biotech Changes - A Pledge for Global Convergence
The Ever-increasing Complexity of Biotech Changes - A Pledge for Global Convergence Wassim Nashabeh Global Head Pharma Technical Regulatory Policy F. Hoffmann-La Roche, Basel, Switzerland CMC Strategy
More informationBIOPHARMA SOLUTIONS TM Expedite Your Drug Development Program
BIOPHARMA SOLUTIONS TM Expedite Your Drug Program Maximize the Value of Your Asset The journey of drug development can be complex stressful. But it doesn t have to be that way. Join more than 600 biopharmaceutical
More informationKelly Thom Associate Principal Scientist Fujifilm Diosynth Biotechnologies. Your Biologics and Vaccines CDMO Partner of Choice.
Process Design for an All Single-Use Manufacturing Facility: Scaling Low to High Titer Processes to Fit Standard mab Equipment BioProcess International West March 2, 2017 Kelly Thom Associate Principal
More informationApplying QbD to Bioprocesses
Applying QbD to Bioprocesses IFPAC Cortona Conference on, QbD/PAT: Advanced Technological and Regulatory Developments Impacting Pharmaceutical Manufacturing and Control, 19 th -22 nd September 2010 Definitions
More informationDebendra K. Sahoo INSTITUTE OF MICROBIAL TECHNOLOGY CHANDIGARH
Thursday 5 November EU-India PARTNERING EVENT Theme: Life sciences, biotechnology and biochemistry for sustainable non-food products and processes IMTECH Debendra K. Sahoo INSTITUTE OF MICROBIAL TECHNOLOGY
More informationAssessing and Managing Strategic Risk for Next Generation Processes of Established Brands Eric R. Garr Associate Director, Global Product Development
Assessing and Managing Strategic Risk for Next Generation Processes of Established Brands Eric R. Garr Associate Director, Global Product Development and Supply Our Mission To discover, develop and deliver
More informationBiopharmaceuticals A Regulatory Perspective
Biopharmaceuticals A Regulatory Perspective Maeve Lally Senior Pharmaceutical Assessor (Biologics) CASSS CMC Forum Killarney May 2017 Cead Mile Fáilte A hundred thousand welcomes 26/06/2017 2 Disclaimer
More informationAdvanced Certificate in Biopharmaceutical Manufacturing
2-Week Training Cohort: December 17-21, 2018 and January 7-11, 2019 The Advanced Certificate in Biopharmaceutical Manufacturing immerses participants in a rigorous digital and hands on training program,
More informationBiosimilars & Pharmaceuticals Feb 28-March 01, 2019 Osaka, Japan
conferenceseries.com International Conference on Biosimilars & Pharmaceuticals Feb 28-March 01, 2019 Osaka, Japan 200+ 15+ 10+ 50+ 3+ 10+ B2B Participation Interactive Sessions Keynote Lectures Plenary
More informationAdvanced Certificate in Biopharmaceutical Manufacturing
2-Week Training Cohort: December 17-21, 2018 and January 7-11, 2019 The Advanced Certificate in Biopharmaceutical Manufacturing immerses participants in a rigorous digital and hands on training program,
More information3rd Annual Global Drug Bioavailability Enhancement Summit
3rd Annual Global Drug Bioavailability Enhancement Summit Event Summary Most drugs on today s market display poor solubility, but the use of modern solubilization technologies can improve a drug product
More informationNANO TECHNOLOGY AND MATERIAL SCIENCE EXPO Propel New Technologies by Integrating Nanoscience and Material structures
NANO TECHNOLOGY AND MATERIAL SCIENCE EXPO 2017 Propel New Technologies by Integrating Nanoscience and Material structures DUBAI, December 04-06, 2017 Contact Us nanoscience@linkinscience.com 649 Mission
More informationTuesday, June 26, 2018 Hyatt regency Hotel, New Brunswick, New Jersey
Learn. Connect. Optimize. Tuesday, June 26, 2018 Hyatt regency Hotel, New Brunswick, New Jersey education Forums networking keynote speaker Keynote Speaker: Chairman & CEO of Corning Inc. wendell p. weeks
More informationVendor Neutral Host Cell Protein Analysis
Vendor Neutral Host Cell Protein Analysis Regulator Positions on HCPs VERY CLEAR Regulators classify residual host cell proteins (HCPs) as process-related impurities [ICH Q6B, Q2B]. Finding, measuring
More informationABL Europe s GMP manufacturing facility for viral vector production
ABL Europe s GMP manufacturing facility for viral vector production New Production Capacity for Viral Vectors Success Story ABL Europe GMP manufacturing of viral vectors from non-adherent cell cultures
More informationMAKING REAL-TIME PROCESS ANALYTICAL TECHNOLOGY IN BIOMANUFACTURING A REALITY
INDUSTRY LEADER INSIGHT MAKING REAL-TIME PROCESS ANALYTICAL TECHNOLOGY IN BIOMANUFACTURING A REALITY > BY CLINT PEPPER, Ph.D., CAPSUGEL/BEND RESEARCH utomated, aseptic sampling and analysis is a prerequisite
More informationSeminar on Product Stability and Predictive Tools by GEA-NUS, Singapore & FreeThink, US
Seminar on Product Stability and Predictive Tools by GEA-NUS, Singapore & FreeThink, US Thursday, 28 June 2018 Time Activity 08:00 08:30 Registration 08:30 08:40 Welcome address 08:40 09:30 Water sorption
More informationIntroduction of Development Center for Biotechnology TAIWAN
Introduction of Development Center for Biotechnology TAIWAN DCB Nonprofit Organization Founded in 1984 Funded Mainly by Ministry of Economic Affairs (MOEA), National Science Council and the Industry 394
More informationGlobal Pharma Summit
allied academies Global Pharma Summit September 03-04, September 03-04 Theme: Advanced Pharma Technologies-Better Healthcare system Sponsorship For More Details For Queries pharmaceutical@alliedmeetings.com
More informationContinuously Improving Bioprocesses: Biopharmaceutical Capabilities
Continuously Improving Bioprocesses: Biopharmaceutical Capabilities Pall Corporation A Legacy of Innovation Dr. David B. Pall Founded by Dr. David B. Pall in 1946, Pall Corporation has grown from a company
More informationDownstream Processing for Production of Biologicals
Downstream Processing for Production of Biologicals... Overview: Bio-therapeutics form an important part of modern medicines. Complexity of bio-therapeutics molecules necessitates elaborate purification
More informationCONTRACTING CELL CULTURE
CONTRACTING CELL CULTURE BIOTECH EXPERIENCE Page 2 Professionals in proteins and antibodies Bayer HealthCare has more than 130 years of experience in developing and producing pharmaceuticals. An integral
More informationA New Cellular and Molecular Engineering Curriculum at Rice University
Session A New Cellular and Molecular Engineering Curriculum at Rice University Ka-Yiu San, Larry V. McIntire, Ann Saterbak Department of Bioengineering, Rice University Houston, Texas 77005 Abstract The
More informationspeeding medicines to people Potential Benefits of PAT for Biomanufacturing IFPAC 2005
speeding medicines to people Potential Benefits of PAT for Biomanufacturing IFPAC 2005 Outline PAT for Biologics (Biotherapeutics) Mfg. What is a biotherapeutic? Converging trends in Biotech PAT player
More informationBiotech Career Pathways: Your Journey at UC Davis!
Biotech Career Pathways: Your Journey at UC Davis! Denneal Jamison-McClung, PhD Assoc. Director, UC Davis Biotech Program Director, BioTech SYSTEM http://biotechsystem.ucdavis.edu dsjamison@ucdavis.edu
More informationInnovative Pharmaceutical Solutions for Discovery Chemistry, Biology and cgmp Manufacturing
Innovative Pharmaceutical Solutions for Discovery Chemistry, Biology and cgmp Manufacturing Overview Serving biotech and pharma community since 1998 Proven track record of advancing small molecules from
More informationWorkshops (Health & Regulatory, Business Development, Vaccines & Global Health)
About the Convention: Organized by the Biotechnology Industry Organization (BIO), this second annual event will bring together biotech and pharmaceutical companies interested in policy issues and business
More informationOpportunities and Challenges to The Implementation of New Technologies and Innovation in Pharmaceutical Manufacturing
Opportunities and Challenges to The Implementation of New Technologies and Innovation in Pharmaceutical Manufacturing Ferdinando Aspesi Global Head, Pharma Developmental Quality Goals Lay the framework
More informationINNOVATIVE SOLUTIONS IN THE PHARMACEUTICAL INDUSTRY
INNOVATIVE SOLUTIONS IN THE PHARMACEUTICAL INDUSTRY Soula Kyriacos, B.Pharm, PhD Head R&D, Pharmaline May 2017 Next-generation patients demand next-generation innovation Patient expectations rise We are
More informationBiotechnology and Health Care
0+ conferenceseries.com nd International Convention on Biotechnology and Health Care April 17-18, 019 Osaka, Japan Theme: Future Directions to Biotechnology and Healthcare 0+ Exhibitors BB Meetings Invitation
More informationTAIWAN. Who Should Attend? Endless Potential & Opportunities. Where innovations are shaping a new era of intelligent healthcare.
TAIWAN Where innovations are shaping a new era of intelligent healthcare World-class medical centers and hospitals Over 1800 biotech companies Best healthcare system in the world Top-ranked life science
More informationThermo Scientific Metabolic Pathway Design Process Cell culture media and process optimization approaches for optimal biotherapeutic production
Thermo Scientific Metabolic Pathway Design Process Cell culture media and process optimization approaches for optimal biotherapeutic production May/June 2013 1 The world leader in serving science Agenda
More informationBiotechpharma company profile. Romanas Ramanauskas Business development manager
Biotechpharma company profile Romanas Ramanauskas Business manager October, 2012 1 Contents History Company overview Services and capabilities Expression system and process Technology scale-up and GMP
More informationThe Changing Landscape of Mammalian Cell Culture Manufacturing Capacity
The Changing Landscape of Mammalian Cell Culture Manufacturing Capacity Howard L. Levine, Ph.D. Eighth Annual bioprocessuk Conference Nov 30-Dec 1 2011 Glasgow, Scotland BioProcess Technology Consultants
More informationThe Biotechnology Program at Montgomery College
The Biotechnology Program at Montgomery College www.montgomerycollege.edu/biotech Presented dby Dr. Collins Jones Biotechnology Coordinator Germantown Campus Montgomery College Collins.jones@montgomerycollege.edu
More informationISPE Annual Meeting 29 October 1 November 2017 San Diego, CA. FDA Perspective on the Use of Process Capability
FDA Perspective on the Use of Process Capability Chunsheng Cai, Ph.D. Office of Process and Facilities Office of Pharmaceutical Quality, CDER, FDA 2017 ISPE Annual Meeting & Expo Disclaimer This presentation
More informationJefferies 2016 Healthcare Conference. June 8, 2016
Jefferies 2016 Healthcare Conference June 8, 2016 Safe Harbor This presentation contains forward looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities
More informationA qualitative approach to bioprocess monitoring and decision making with NIR-Spectroscopy and MVDA.
A qualitative approach to bioprocess monitoring and decision making with NIR-Spectroscopy and MVDA. Dan Kopec - Field Marketing Manager Sartorius Stedim Biotech N.A. Sartorius and PAT Ready to use Solutions
More informationManaging QbD From A CMO Perspective
Managing QbD From A CMO Perspective By Cathy Yarbrough The concepts and methods of Quality by Design (QbD), which the automobile, airline, and electronics industries have utilized to enhance the quality
More informationExhibitor Information Advances in Cell Based Screening 2017
Exhibitor Information Advances in Cell Based Screening 2017 10 th and 11 th May-2017 www.elrig.org Advance Information for Exhibitors: Please note that it is NOT possible to enter via the AstraZeneca main
More information2016 Editorial. Advancing Development & Manufacturing. Calendar w w w. P h a r m Te c h. c o m. Editorial coverage
Advancing Development & Manufacturing 2016 Editorial Calendar w w w. P h a r m Te c h. c o m COMPlete Editorial coverage EDITORIAL COVERAGE: EXPERT INSIGHT AND ANALYSIS Pharmaceutical Technology continues
More informationEBF Recommendation for Stability Testing of Anti-Drug Antibodies; Lessons Learned from Anti-Vaccine Antibody Stability Studies
EBF Recommendation for Stability Testing of Anti-Drug Antibodies; Lessons Learned from Anti-Vaccine Antibody Stability Studies Presenter: Janka Ryding Presentation based on publication: Pihl S, Michaut
More informationHealthcare. Healthcare. The Centre for Process Innovation. From innovation to commercialisation
Healthcare Healthcare The Centre for Process Innovation From innovation to commercialisation The Centre for Process Innovation From innovation to commercialisation The Centre for Process Innovation (CPI)
More informationENTREPRENEURIAL OPPORTUNITIES IN LIFE SCIENCE QUALITY & REGULATORY
BIOANALYTICAL SOLUTIONS FOR BIOTHERAPEUTICS AND SMALL MOLECULE THERAPEUTICS ENTREPRENEURIAL OPPORTUNITIES IN LIFE SCIENCE QUALITY & REGULATORY MARCH 15, 2017 AIT BIOSCIENCE, LLC BIOANALYSIS TO SUPPORT
More informationWelcome to. April 4-5, DoubleTree by Hilton Hotel Silver Spring, MD USA
Welcome to April 4-5, 2016 DoubleTree by Hilton Hotel Silver Spring, MD USA What is CASSS? Practical Applications of Mass Spectrometry EUROPE JAPAN NORTH AMERICA SOUTH AMERICA CASSS is the leading non-profit
More informationSponsorship. Pharmaceutical Analytical Chemistry & Technology. allied. June academies. International Conference on
allied academies International Conference on Pharmaceutical Analytical Chemistry & Technology June 28-29, Theme: Exploring the Recent Trends & Advances in the Field of Pharma and Chemistry June 28-29 Sponsorship
More informationQuality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)
Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries) *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Today, many companies operate
More informationKAISER OPTICAL SYSTEMS, INC. Application Note. Representative sampling in process Raman spectroscopy
KAISER OPTICAL SYSTEMS, INC. Application Note Representative sampling in process Raman spectroscopy Raman spectroscopy is an analysis technique that provides a molecular fingerprint of the sample, enabling
More informationGibco BioProduction Services
Gibco BioProduction Services Custom solutions tailored to suit your bioproduction needs A comprehensive portfolio to fit your unique needs Regardless of your stage of development or specialized needs,
More informationGlobal Industrial Perspective of Novel Biologicals Development
Global Industrial Perspective of Novel Biologicals Development Anthony S. Lubiniecki, Sc.D. Vice President, Technology Transfer & Project Planning Centocor R&D/Johnson & Johnson What Kind of Biotechnological
More informationEFFECTIVE PROCESS VALIDATION NUSAGE PharmEng Pharmaceutical and Biotechnology Training Program Copyright 2014 NUSAGE-PharmEng.
EFFECTIVE PROCESS VALIDATION NUSAGE PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry EFFECTIVE PROCESS VALIDATION Objective
More information