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Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder...

Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Blend Homogeneity in Continuous Manufacturing

In continuous direct compression of pharmaceutical formulations, it is essential to assess the homogeneity of powder blends. This could preferably be done in situ, using fast spectroscopic techniques. In this study, near-infrared spectroscopy was used to study powder blend homogeneity at two positions in the continuous manufacturing process; after the first blender and in the tablet press feed-frame. The focus of the study was on sample presentation at the two positions, and several sampling devices were tested in a laboratory setting using a model formulation, aiming at improving the quality of the NIR measurements. The results for the sampling devices tested are compared and the future implementation in the continuous manufacturing equipment is discussed.

Followed by Powder Blend Homogeneity Monitoring with the Viavi MicroNIR PAT-W

The MicroNIR PAT-W wireless NIR spectrometer is used in monitoring blend uniformity in pharmaceutical manufacturing. The PAT-W is a rugged, IP65/67 rated instrument with no moving parts. The PAT-W, with >8 hours battery life, WiFi communication and onboard gravity sensor is well suited for use on tumble blenders in regulated facilities. Viavi’s Linear Variable Filter technology, optical fiber-free design and dual onboard tungsten lamps ensure excellent stability, long lifetime and minimal instrument-to-instrument variability. Viavi MicroNIR Pro software provides data acquisition and chemometric model building, and assures compliance with Title 21 CFR Part 11, USP chapter 1119 and EP chapter 2.2.40. OPC communication and control are also available for use in process environments.
Recorded Aug 11 2020 73 mins
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Presented by
Anders Sparén Associate Principal Scientist at AstraZeneca and Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI
Presentation preview: Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder...
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  • Regulatory Strategies For Rapid Sterility Testing... Mar 7 2022 3:00 pm UTC 120 mins
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    Eileen Martin Merck KGaA, Darmstadt, Germany, Global Director of Diversity, Equity and Inclusion
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    Our global strategic diversity, equity and inclusion plan has a particular focus on gender. We aspire to increase representation of women in management and leadership positions across our healthcare, life science and electronics sectors. The leaders at Merck will track progress of women in leadership roles, along with other key metrics, including gender balance in our development courses, succession plans, and the sponsorship of women. In a world where women make up 50 percent of the population, we want to make Merck more reflective of the countries in which we do business and better reflect the customers we serve.
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    Irving Ford at Bristol Myers Squibb and Lori Daane at bioMérieux
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    Introduction to cartridge technology and its benefits
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    Robert Gronke, Ph.D., Senior Principal Scientist, at Biogen and John Cyganowski, Director of Customer Application, Merck
    Following on the commercial success of Spinraza® (the first successful treatment for patients with spinal muscular atrophy), antisense oligonucleotides (ASO) are now an important part of Biogen’s drug portfolio that enables us to better treat neuromuscular diseases. Development of the ASO process employs orthogonal chromatography to achieve industry high purities while maintaining good yield along with detritylation and UF/DF steps.  This purification platform process is all aqueous based on green chemistry principals that easily fits into our existing biologics manufacturing facilities. To date, we now leverage this ASO platform process to purify 13+ ASO molecules that contain different sequences, chemistries, and most recently incorporating conjugation reactions.

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    Jurgen Mulberg Associate Director at Bristol Myers Squibb and Joanna Zmurko, NGS specialist at PathoQuest
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  • Integrity Assurance for Single-Use Systems: End-User Perspective Recorded: Oct 6 2021 126 mins
    Charlotte Masy at GSK Vaccines and Patrick Evrard at Pall Life Sciences
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    The regulatory environment has significantly evolved in last years, with the publication of new guidance and standards and additional ones in preparation.  Current draft of EU GMP Annex 1 illustrates the increased scrutiny of regulatory authorities on this topic.  

    We will position integrity tests in the more global picture around integrity strategy. Concepts such as QbD and QRM, as well as close collaboration between supplier and end-user are required to build a good strategy and enhance the integrity assurance for processes using single-use systems. A defined integrity control strategy is very important for critical applications where single use systems are used after last sterile filtration step or in a process where no sterile filtration is possible.

    We will discuss the different technologies available on the market to control integrity of single-use systems and key parameters that are affecting integrity measurements, at supplier’s and at end-user’s side.

    Several case studies will be shared, illustrating how integrity concerns can be practically addressed for cGMP manufacturing applications, and what are the results observed after a few years of use.
  • Sanofi’s Journey & Strategy for Continuous Processing for Small Molecules Recorded: Sep 27 2021 117 mins
    Flavien Susanne at Sanofi and Sean Bermingham at PSE Ltd
    In the past decade, there has been a growing interest in the application of continuous processing in the pharmaceutical industry with 100s millions of investments and several products delivered to the market using this technology. 

    Continuous processing demonstrates several value propositions for the Pharmaceutical industry. Amongst them we can name, access to better chemistry, product quality enhancement, reduction of CoGs but mostly speed to market where phase 3 to launch is drastically accelerated. 

    Sanofi R&D is building capacities to perform future GMP clinical batches using this technology. The first investment was completed last year, and we are in the process of expansion. It is a really changing time for science at Sanofi.  

    Sanofi is investing in modular concept with high capability of production of API and ability of infinite reconfiguration. We are not only thinking machine; to enhance our ability to always produce best quality drugs to our patient, we are also implementing digital twin system, tracking and controlling the quality of our product at any moment of time. 

    We are ready to meet the challenges of tomorrow and produce the new APIs to help patients.
  • The Business Benefits of PAT in Continuous Drug Product Manufacturing Recorded: Sep 22 2021 64 mins
    Steve Hammond, Independent Consultant at Steve Hammond Consulting
    It is well recognized that continuous processing requires continuous monitoring, at the “heart-beat” of the process to ensure product quality and patient safety. However, the use of PAT in the optimization of equipment and the development of processes from which a product will be manufactured is also of significant value, and justifies the investment in PAT for a continuous manufacturing. The data density and timeliness can deliver immediate feedback and exquisitely detailed information on the success of processing steps. The gathered information can aid in the establishment of an effective and robust processing regime for new or existing products.

    This paper will discuss the use of information rich PAT technologies to understand equipment and process steps during development. Examples of equipment characteristics and the effect on the product will be examined.

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    Oliver Steinhof, PAT Scientist at Biogen and Nicolas Langenegger, Senior Associate Scientist at Biogen
    Full Title: Development of automated chemometric platform for accelerated Raman-based model optimization in biologics

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  • Vaccine Development & its Manufacturing using Integrated... Recorded: Sep 20 2021 151 mins
    Dr. S.K. Jana at Serum Institute of India Pvt. Ltd, Vikas Revankar at Merck and Piergiuseppe Nestola at Sartorius
    Full Title: Vaccine Development & its Manufacturing using Integrated High Throughput Technology

    The billions of doses of vaccines manufactured worldwide each year are used to vaccinate the healthy people. This is the fact which drives vaccine manufacturing to be among rigorously designed, manufactured, monitored & compliant health products. In order to produce this huge number of doses, there is a need to have a manufacturing process which strongly influence the cost effectiveness, volume, application of technologies involving ease of scale-up, flexible in nature, automated integration with different manufacturing unit operations, minimal manual intervention or hybrid for complex biologics like vaccines manufacturing. The use of integrated way of automation with different online sensors like IOTs, AI at different measurement points of processes to make manufacturing process continuous, seamless, robust with high throughput yield, higher process capability with less time or no failure is the cornerstone of a modern, advanced & powerful manufacturing system. The concept of High Throughput Manufacturing is related to time required for a product to pass through a manufacturing process converting raw materials in to finished goods involving automation, integration of several unit operations with minimal manual intervention during the manufacturing. The ability to manufacture vaccines safely and consistently must be built on the theme with consistent quality, compliance, easier regulatory authorization in order to reach the market fast as manufacturing complexity is compounded by the need for different producing strains, type of vaccines & their processes. The present talk on “Vaccine Development and its manufacturing using integrated high through put Technology” is going to address some challenges & opportunities and its full scale application to future biologics manufacturing.
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  • Title: Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder...
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  • Presented by: Anders Sparén Associate Principal Scientist at AstraZeneca and Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI
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