Continuous Manufacturing as a Default Platform for Oral Solid Drug Products
Presented by Lawrence De Belder, Senior Principal Engineer Continuous Manufacturing at Johnson and Johnson
Followed by an Industry Perspective presented by Bob Lenich, Director of Life Sciences Business at Emerson
The counter is at Six today: Orkambi, Symdeko, Trikafta (Vertex); Prezista (Johnson and Johnson); Verzenio (Eli Lilly); Daurismo (Pfizer) –are all approved by the FDA – Johnson and Johnson’s Tramacet for the Japanese market not included. Several large Pharma companies have chosen the path of Continuous Manufacturing, and announced they will use this platform as their default for development and consequently – commercial manufacturing of their Oral Solid dose drug product pipeline.
During this webinar, the author will explain the consequences of this decision, and different strategies to handle a pipeline that can be highly dynamic. Different techniques will be discussed that can be used to bring products with bad flow properties into a continuous process. Impact of different equipment in development, clinical and commercial environment will be detailed out, and mitigations will be proposed to overcome these differences. All will be placed in front of a background of regulatory requirements, changing market demand, and evolving strategies of equipment vendors.
Followed by an Industry Perspective presented by Bob Lenich, Director of Life Sciences Business at Emerson
The counter is at Six today: Orkambi, Symdeko, Trikafta (Vertex); Prezista (Johnson and Johnson); Verzenio (Eli Lilly); Daurismo (Pfizer) –are all approved by the FDA – Johnson and Johnson’s Tramacet for the Japanese market not included. Several large Pharma companies have chosen the path of Continuous Manufacturing, and announced they will use this platform as their default for development and consequently – commercial manufacturing of their Oral Solid dose drug product pipeline.
During this webinar, the author will explain the consequences of this decision, and different strategies to handle a pipeline that can be highly dynamic. Different techniques will be discussed that can be used to bring products with bad flow properties into a continuous process. Impact of different equipment in development, clinical and commercial environment will be detailed out, and mitigations will be proposed to overcome these differences. All will be placed in front of a background of regulatory requirements, changing market demand, and evolving strategies of equipment vendors.
Recorded
May 19 2020
99 mins
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Presented by
Lawrence De Belder, Senior Principal Engineer at j&J and Bob Lenich, Director of Life Sciences Business at Emerson
Lawrence De Belder, Senior Principal Engineer at j&J and Bob Lenich, Director of Life Sciences Business at Emerson
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Designer Sterile Filtration in Aseptic Processing Using Single Use Technology Nov 4 2020 3:00 pm UTC 90 mins
Alan Kelly, Project Engineer at SanofiAlan Kelly is a Project Engineer who has been employed within the pharma/biopharma industry in Ireland for the past 25 years and is currently in his 18th year at Sanofi Waterford. Previous employers include Leo Pharma and Elan. During his current tenure at Sanofi Alan has held several engineering roles, including Project Lead on two high speed aseptic vial-filling isolator technology lines integrated with industrial scale freeze dryers and as Process Engineering Manager during start-up of fill finish. Alan has worked in the Technical Services Department at Sanofi responsible for technical expertise input into front-end studies for new aseptic filling lines with isolator technology. In his most recent role in MSAT, Alan is responsible for next generation product transfers, identifying innovative technology including: real time microbial monitoring, drone vial studies to assess aseptic filling line set-ups and multi-purpose PAT technology for detection of trace silicone oil, leak detection and primary/secondary drying functionality for freeze dryers. Alan has successfully led cross functional teams in the qualification of high speed automatic visual inspection technology for cartridges and manual visual inspection of syringes. Alan has presented at international conferences including ISPE (Case study on VHP Cycle Development and Qualification of large scale aseptic Filling Isolator technology, European Compliance Agency (ECA) on “Case study on Manual Visual Inspection of syringes”, Alan is an active member of PDA Ireland Chapter and lead organiser for recent events including Annex 1 Conference (Revision of the EU GMP Guideline) May 2019 and Advances in Aseptic Processing with a focus on Media Fill simulations Oct 2018 -
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Mapping of PAT Tools for Enabling Integrated DSP in Continuous Biomanufacturing Oct 23 2020 2:00 pm UTC 120 mins
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Considerations on Impact of Raw Material Variability in Gene Therapy Oct 22 2020 2:00 pm UTC 105 mins
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Establish Early Development Strategies For Therapeutics Proteins Oct 21 2020 2:00 pm UTC 90 mins
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mAb Industry in China: Biosimilars vs. Innovative Biologics Oct 9 2020 8:00 am UTC 90 mins
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MES-Integrating Technology, Quality and Compliance – Opportunities, Challenges Oct 6 2020 9:30 am UTC 90 mins
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Organizational strategies to leverage the Power of technology by implementing MES. -
Quantification and Control of Amorphous contents by Raman, Application and Case Oct 2 2020 2:00 pm UTC 120 mins
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Amorphous regions in crystalline material can have significant impact on bioavailability, processability and stability. Conversely, crystalline material can act as nuclei for recrystallization and resulting in instability of amorphous systems. Raman spectroscopy is sensitive to polymorphic differences and amorphous content in pharmaceutical materials. This make Raman spectroscopy a powerful process analytical technology (PAT), when combined with multivariate modelling, to control the amorphous content in a pharmaceutical process. We will present pharmaceutical case studies showing process-induced amorphization of crystalline drugs across the DS and DP processing steps. In addition, we will compare the kinetics of crystallization of amorphous material when stored at various relative humidity and temperature conditions. The results clearly demonstrate that Raman spectroscopic techniques combined with multivariate methods is a powerful and effective tool for quantitation of amorphous content in crystalline material with applications ranging from API isolation, milling and to multiple unit operations in DP manufacturing. The information generated was critical to determine the root-causes and outline appropriate mitigation measures -
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Robert Dimitri is a Director in Takeda’s Business Excellence group for the Biologics Operating Unit as the Digital Transformation and Innovation Lead. Previously he led the Digital and Data Sciences group in Manufacturing Sciences at Takeda’s Massachusetts Biologics Site leading a team for the implementation of digital tools used for the analysis of internal manufacturing operations data, used to support the production of biologic drugs to treat rare diseases. He has over 15 years of experience in this field, having worked previously as a process engineer and developing software to perform process data analytics. Robert has a B.S. degree in Chemistry and Computer Science, an M.S. in Computer Science, and an M.B.A.
Followed by an Industry Perspective by Pep Gubau, CTO and co-founder, Bigfinite -
Strategies to Overcome Low Endotoxin Recovery Using the Conventional LAL Assay Sep 28 2020 2:00 pm UTC 105 mins
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Followed By A Presentation From Kevin L. Williams, Microbiological Test Development at bioMérieux -
Current Bacterial Endotoxins Test (BET) and its Intended Use Sep 24 2020 2:00 pm UTC 105 mins
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The Bacterial Endotoxins Test is not a test for pyrogens (fever causing agents). It is not a test for the presence of Gram negative bacteria. Based on extensive comparisons of endotoxins activity in the BET and fever rabbits executed in the 1970s and 1980s, we may say that the BET is a test for levels of Gram negative bacterial endotoxins activity that may be predictive of a fever in mammals.
The various methodologies that are described in the harmonized in the harmonized chapter use the primary Reference Endotoxin Standard (RSE) or secondary Control Standard Endotoxin (CSE) to prepare assay standards, perform suitability testing as instructed in the chapter and inoculate positive product controls. These standards are relatively pure preparations of lipopolysaccharide. However, the utility of the compendial assay for non-compendial applications is limited. Our discussion will focus on the compendial uses of these BET assays. -
A Comprehensive Approach to Assess the Impact of Microbial Impurities on Pat... Recorded: Sep 16 2020 80 mins
Dr Friedrich von Wintzingerode, QC Lead iNeST Project at Roche and Shabnam Solati, CEO & Co-Founder at CTL-MATFULL TITLE: A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics
Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) at Roche
Large-scale Production of Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance (DS) manufacture (manufacture of the Active Pharmaceutical Ingredient), or Drug Product (DP) manufacture (manufacture of the Final Drug, e.g. formulated mAbs filled in vials or syringes) they occur, microbial contaminations can have a significant impact on product quality and patient safety. Even after bioburden removal by 0.2 µm filtration subcellular microbial components like toxins, lipopeptide/lipoproteins, flagellin, bacterial and fungal DNA, cell wall polysaccharides, extracellular proteases or endoglycosidases remain in the product. Those microbial components potentially lead to toxic, allergic or inflammatory responses in humans or product degradation or modification. The Case-by-Case Assessment of Bioburden (CCAB) approach described here enables a comprehensive assessment of these risks. -
Analytical Strategies for Comparability in Bioprocess Development Recorded: Sep 15 2020 52 mins
Dr Christine P. Chan, Director in Global Manufacturing Science & Technology at SanofiBioprocess changes can impact quality attributes of biologics and may affect efficacy and safety of the product. During development and throughout the product lifecycle, when process improvements are implemented, it is essential to gather sufficient data to support the conclusion that product safety and efficacy has not been adversely affected. This demonstration exercise requires careful planning of the comparability studies and is based on the background knowledge of protein structure, biological function, and clinical attribute profiles of the product accumulated during development.
In this webinar, I will discuss the key concepts of establishing product quality profiles, and the hierarchical assessment approach to demonstrating comparability of biopharmaceuticals in support of process changes. -
Mapping Future Technology Needs For Real Time Release Testing Recorded: Sep 14 2020 51 mins
Dr Udayanath Aich, Associate Director at Bristol-Myers SquibbReal 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 product. BioPhorum Operations Group (BPOG) published a Biomanufacturing Technology Roadmap in July 2017 with the active collaboration of Biopharma industry representatives and supply partners. As part of implementation of roadmap strategy, BPOG’s ILM-RTR technical forum team is developing User Requirement Specifications (URS) for prioritized CQA’s and CPP focusing on the critical control points and future requirements of real time release (RTR). The URS documents will promote effective development of desired Short, Mid and Long term technologies by the innovators and supply partners.
Presented by Dr. Udayanath Aich Associate Director at Bristol-Myers Squibb
Dr. Udayanath Aich has an extensive experience and management skills in analytical chemistry, and CMC analytical strategies for early, late and commercial biologics products. He then decided to move to M.I.T to gain extensive skills in the area of Biopharmaceutical characterization and drug development. Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Then Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics, CMC analytical strategies as ATL and structure-function study. Finally, before joining at Bristol Myers Squibb, Uday was working at Sanofi related to high throughput technologies, process analytical technologies (PAT), Analytical method harmonization, multi-attribute method Dev, analytical method dev, robustness, qualification and transfer for early and late stage product including 2nd generation commercial product as part of life-cycle analytics.
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- Title: Continuous Manufacturing as a Default Platform for Oral Solid Drug Products
- Live at: May 19 2020 8:00 am
- Presented by: Lawrence De Belder, Senior Principal Engineer at j&J and Bob Lenich, Director of Life Sciences Business at Emerson
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