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Biopharma Webinar Series
United Kingdom
เข้าร่วมเมื่อ 14 มิ.ย. 2021
BIOPHARMACEUTICAL PROCESS DEVELOPMENT – TRENDS/ CHALLENGES/OPPORTUNITIES
Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS - Global Regulatory and Validation Consulting group at Pall Biotech |
This webinar discusses three things:
1) Current trends and regulations affecting Biopharmaceutical Industry
2) The journey from Lab scale to Commercial -Overcoming Scalability design hurdles
3) QbD-Bringing Improvements in Biologic development and Manufacturing Space.
This webinar discusses three things:
1) Current trends and regulations affecting Biopharmaceutical Industry
2) The journey from Lab scale to Commercial -Overcoming Scalability design hurdles
3) QbD-Bringing Improvements in Biologic development and Manufacturing Space.
มุมมอง: 875
วีดีโอ
JUST IN TIME RELEASE OF CAR T CELL THERAPIES
มุมมอง 158ปีที่แล้ว
JUST IN TIME RELEASE OF CAR T CELL THERAPIES Presented Irving Ford Head of CAR T QC Laboratories at Celgene now VP, Head of Quality at Adaptimmune, followed by Lori Daane, Pharma Microbiology Scientific Director at @bioMérieux The views and opinions expressed during the Webinar are those of the presenter. Currently, CAR T products typically represent the final treatment option for patients suff...
BIOPHARMACEUTICAL PROCESS MODEL EVOLUTION - ENABLING PROCESS KNOWLEDGE & ADVANCED PROCESS CONTROL
มุมมอง 293ปีที่แล้ว
Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen, followed by David Lovett, Managing Director at Perceptive Engineering & John Mack, Engineering Director at Perceptive Engineering Biogen is adopting modelling maturity models similar to the ones used by high-tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ens...
ENGINEERING FIRST PRINCIPLES: APPLICATIONS TO PHARMACEUTICAL MANUFACTURING
มุมมอง 235ปีที่แล้ว
Presented by Bernard McGarvey, PhD Chemical Engineering Within the pharmaceutical industry, creating a robust Operational Control Strategy (OCS) is a key step to accomplishing the goals of Quality by Design (QbD). Along the way to developing this robust Operational Control Strategy, many problems will be encountered that need to be solved. The use of a First Principles based approach provides v...
CASE STUDY & EXPERIENCE ON SANOFI’S & SGS’S IMPLEMENTATION OF BPOG’S LEACHABLE RISK ASSESSMENT MODEL
มุมมอง 156ปีที่แล้ว
Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of E&L at SGS Brief review of the BPOG’s Leachable Risk Ranking model. A case study of the leachable risk model implementation into Sanofi will be presented. All changes to specific risk factors and weights changes will be discussed. Finally, the lesson learns and experiences of the risk model performanc...
THE JOURNEY TO LEAN IMPLEMENTATION FOR EFFICIENCY INCREASE
มุมมอง 67ปีที่แล้ว
Presented by Uwe Voelker, Previously Site Head, Sterile Drug Product Manufacturing at Roche & now Senior Executive in Quality and Technical Operations, a.o. Roche. This webinar discusses: 1) Adoption of strategic and systematic use of lean principles to improve 2) operational efficiencies and cost competitiveness 3) Systematic reduction of waste, complexity and variability, 4) Reduction of orde...
BEYOND PURELY DATA-DRIVEN APPROACHES FOR EFFICIENT KNOWLEDGE MANAGEMENT IN PROCESS DEVELOPMENT
มุมมอง 762 ปีที่แล้ว
Presented by Previously Moritz von Stosch, PhD, Previously Senior Manager, Technical R&D, GlaxoSmithKline Vaccines and now Chief Innovation Officer at DataHow AG Followed by Klaus Mauch, CEO at Insilico Biotechnology AG and Shilpa Nargund Data Scientist and Business Development Manager at Insilico Biotechnology AG Knowledge from first principles is freely available and generally valid, and when...
CHARACTERIZATION OF BIOTHERAPEUTICS
มุมมอง 1.1K2 ปีที่แล้ว
Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia followed by Dr Kai Scheffler, Product Manager at Thermo Fisher Scientific Biotherapeutic products are typically characterized by multiple orthogonal methods to evaluate product quality and purity, including the assessment of aggregates, variants, and degradation products. For monoclonal antibodies and...
DESIGN OF EXPERIMENTS (DOE) FOR DEVELOPMENT OF HIGH THROUGHPUT, FOR ASSESSMENT OF PRODUCT QUALITY
มุมมอง 4662 ปีที่แล้ว
Presented by Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca Being able to generate accurate and precise analytical data to provide information on product quality in a timely manner is a great challenge facing analytical groups. By adopting a Design of Experiments (DoE) approach, we can overcome many hurdles facing the implementation and a...
FROM CONCEPT TO MARKET - UNIQUE APPROACHES IN BIOMANUFACTURING
มุมมอง 1212 ปีที่แล้ว
Presented by Jincai Li, Vice President of WuXi Biologics and Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific With the rapid growth of the biotherapeutics industry, the need and challenge for high-quality cost-efficient production have been increasing as well. At the same time, the number of approved biologics products are also steadily increasing, and more and ...
BIG DATA STRATEGIES FOR CELL THERAPY MANUFACTURING
มุมมอง 1682 ปีที่แล้ว
Presented by Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC And Heidi Hagen, Co-founder and Chief Strategy Officer for Vineti Inc. The quest to retrieve, analyze, and leverage that data has become the new gold rush in life sciences. This presentation will discuss the role of big data in cell therapy process development, real-time analytics and commercial scale manufacturing.
CASE STUDY & EXPERIENCE ON SANOFI’S & SGS’S IMPLEMENTATION OF BPOG’S LEACHABLE RISK ASSESSMENT MODEL
มุมมอง 1652 ปีที่แล้ว
Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of E&L at SGS. A brief review of the BPOG’s Leachable Risk Ranking model. A case study of the leachable risk model implementation in Sanofi will be presented. All changes to specific risk factors and weight changes will be discussed. Finally, the lesson learns and experiences of the risk model performanc...
ALTERNATIVE AND RAPID MICROBIOLOGICAL METHODS: MICROBIOLOGY OF THE 21ST CENTURY
มุมมอง 3432 ปีที่แล้ว
Presented by Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr. David Jones, Director of New Products & Industry Affairs at Rapid Micro Biosystems. Today Pharmaceutical industry remains conservative for microbiology testing methods and has the reluctance to develop and to use Alternative and Rapid Microbiological Methods (RMM) supported by a number of misunderstandings ...
THE JOURNEY TO LEAN IMPLEMENTATION FOR EFFICIENCY INCREASE
มุมมอง 512 ปีที่แล้ว
Presented by Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche Discussing: 1) Adoption of strategic and systematic use of lean principles to improve operational efficiencies and cost competitiveness 2) Systematic reduction of waste, complexity and variability, Reduction of order lead time, 3) Higher employee satisfaction and engagement in tackling the cultural challenges 4) Ac...
MAPPING FUTURE TECHNOLOGY NEEDS FOR REAL TIME RELEASE TESTING
มุมมอง 1012 ปีที่แล้ว
Presented by Dr Udayanath Aich, Associate Director at Bristol-Myers Squibb Real-time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring), in order to address biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of the product. BioPho...
DESIGNING PRODUCTION FACILITIES OF THE FUTURE
มุมมอง 2292 ปีที่แล้ว
DESIGNING PRODUCTION FACILITIES OF THE FUTURE
USE OF COMPUTATIONAL MODELLING IN SPECIFICATION SETTING AND ESTABLISHING CONTROL STRATEGY
มุมมอง 782 ปีที่แล้ว
USE OF COMPUTATIONAL MODELLING IN SPECIFICATION SETTING AND ESTABLISHING CONTROL STRATEGY
CHEMICAL & PHYSICAL TRANSFORMATION MONITORING BY RAMAN & IR SPECTROSCOPIES IN PHARMA DEVELOPMENT
มุมมอง 892 ปีที่แล้ว
CHEMICAL & PHYSICAL TRANSFORMATION MONITORING BY RAMAN & IR SPECTROSCOPIES IN PHARMA DEVELOPMENT
PHARMACEUTICAL FORENSICS FOR SAFE MANUFACTURING AND SUPPLY
มุมมอง 762 ปีที่แล้ว
PHARMACEUTICAL FORENSICS FOR SAFE MANUFACTURING AND SUPPLY
PHARMACEUTICAL HOT MELT EXTRUSION A COST EFFECTIVE METHOD TO INCREASE SOLUBILITY
มุมมอง 5612 ปีที่แล้ว
PHARMACEUTICAL HOT MELT EXTRUSION A COST EFFECTIVE METHOD TO INCREASE SOLUBILITY
NEW DRUG PRODUCT DEVELOPMENT USING CONTINUOUS MANUFACTURING
มุมมอง 2432 ปีที่แล้ว
NEW DRUG PRODUCT DEVELOPMENT USING CONTINUOUS MANUFACTURING
REGULATORY STRATEGIES AND CASE STUDIES FOR RAPID STERILITY TESTING OF GENE AND CELL THERAPY PRODUCTS
มุมมอง 2922 ปีที่แล้ว
REGULATORY STRATEGIES AND CASE STUDIES FOR RAPID STERILITY TESTING OF GENE AND CELL THERAPY PRODUCTS
VIRAL SAFETY BY DESIGN FOR CELL AND GENE THERAPY PRODUCTS
มุมมอง 2662 ปีที่แล้ว
VIRAL SAFETY BY DESIGN FOR CELL AND GENE THERAPY PRODUCTS
CHARACTERIZATION OF SUBVISIBLE PARTICLES IN PROTEIN AND VIRAL VACCINES
มุมมอง 1812 ปีที่แล้ว
CHARACTERIZATION OF SUBVISIBLE PARTICLES IN PROTEIN AND VIRAL VACCINES
DO EXTRACTABLE PROTOCOLS TRULY HELP - AN END USER PERSPECTIVE
มุมมอง 572 ปีที่แล้ว
DO EXTRACTABLE PROTOCOLS TRULY HELP - AN END USER PERSPECTIVE
HOT MELT EXTRUSIONS AS A COST EFFECTIVE METHOD OF INCREASING SOLUBILITY OF WATER INSOLUBLE API’S
มุมมอง 2462 ปีที่แล้ว
HOT MELT EXTRUSIONS AS A COST EFFECTIVE METHOD OF INCREASING SOLUBILITY OF WATER INSOLUBLE API’S
APPLYING LOW FREQUENCY RAMAN TO QBD IN PHARMACEUTICAL DEVELOPMENT
มุมมอง 1042 ปีที่แล้ว
APPLYING LOW FREQUENCY RAMAN TO QBD IN PHARMACEUTICAL DEVELOPMENT
PDA TECHNICAL REPORT ON LOW ENDOTOXIN RECOVERY: IMPLICATIONS TO THE INDUSTRY
มุมมอง 7252 ปีที่แล้ว
PDA TECHNICAL REPORT ON LOW ENDOTOXIN RECOVERY: IMPLICATIONS TO THE INDUSTRY
Hello, Very helpful information. Could you suggest for veterinary injection and injection for suspension, oily formulation.
Est-ce que vous pouvez expliquer comment vous avez trouvé les intervalles pour chaque niveau de risque : faible, moyen et fort ?
Are there accessible powerpoints or journals that I can access regarding this research?
How about fluoresence
Great presentation Gaurav
Thanks
Silly question but why are oligosaccharides tested? Do they signal the degradation of the drug/product with their presence?
I don’t believe they’re stability indicating. It can be variable during manufacturing and can impact safety and efficacy so should be tested for batch disposition before release of material
Thanks .. very interesting collection of info
Excellent job gentlemen
these 💉 freaks are a existential threat to our children! 🔎 *"Nucleic acid delivery of immune-focused $ARS-C0V-2 nanoparticles drive rapid and potent immunogenicity capable of single-dose protection"* published in the journal Cell Reports. Novel nanoparticle $ARS-C0V-2 vaccine combines immune focusing and self-assembling nanoparticles... trust the Science juice! Nope.
Nice job!