James Dean Vogel

Are you interested in learning more about #QPS #bioanalysis capabilities? Get an inside look at the QPS laboratories in this short video. To learn more, visit https://shorturl.at/asPrS or email [email protected]. 

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Another fantastic ISPE Delaware Valley Chapter (ISPE DVC) meeting in the books! Albert Dyrness gave an illuminating talk on Computational Fluid Dynamics and its applications in #pharma and #biopharma manufacturing. Our motto is "Know it Before You Build it." Learn how you can leverage this technology to save time and scaleup costs by downloading our free ebook, "Applications of Computational Fluid Dynamics in Pharmaceutical Manufacturing" - https://lnkd.in/ee_W_RQh. #CFD #processengineering #lifesciences #CQV #knowitbeforeyoubuildit

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Come see the power of multi-omics from the most experienced partner for gene expression at the single-molecule/single-cell level - RNAscope

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Last week at a ISPE Delaware Valley Chapter (ISPE DVC) and Merck-hosted event, Genesis AEC's ATMP and Biologics Leader, Jeff Odum, CPIP, and Marc Pellitier, co-delivered a powerful presentation on the groundbreaking 3rd edition of the ISPE Biomanufacturing Facilities Baseline Guide. This edition signifies a paradigm shift in the life sciences industry, challenging traditional design solutions and focusing on closed systems, contamination control, and product protection. Using case study examples, the session explored the practical implementation of this guide and its impact on risk assessment, process closure, and operational efficiency. Key takeaways included: - New terminology establishing a common industry language (for the 1st time in 20+ years) - Closure Risk Assessments (CLARAs) - Fault Tree Analyses for bioreactor contamination assessments - Use of HACCP risk assessments for process closure - Layer-of-protection analysis (LOPA) for operational efficiency - Bacteriostatic process zones for product protection The presenters illustrated how these tools can lead to significant capital cost reduction. Using a series of scenarios tied to a traditional fed-batch as well as a large-scale MAb scenario, they pinpointed reductions in footprint size, classified space needs, TIC, and equipment optimization. The 3rd edition of the Baseline Guide represents a monumental step forward in biomanufacturing, and this session provided invaluable insights into its practical application. Interested in learning more or obtaining a copy of the presentation? Email us at [email protected]. #ISPE #Biomanufacturing #BaselineGuide #GenesisAEC #ATMP #Biologics #JeffOdum

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It may be a beautiful morning here in NJ- but this story is a bit dark. It at least partially answers the question posted here last Saturday - " How did things get this far?" [ https://lnkd.in/ePsgVRnm ] In part at least, there were out-dated practices, resistance to change and something many in the field are familiar with. When the new resource ( here an employee but how often a consultant?) pushes these changes, they get fired. While the story is a concise read - that sounds eirely familiar - you can also hear 'the resource that tried' in his own voice if you care to. And would you expect to see data integrity issues at a. cold cuts plant? Reports were not quite accurate and remediations were never verified. Hopefully you will find this an interesting read, if not exactly "appetizing" ? Here's the link with text and video. #boarshead #listeria #dataintegrity #virginia #usda

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Throwing it back to our first Life Science Seminar of 2024. Industry experts gathered to dive deep into the differences between Biology and Chemistry labs. Our moderator, Greg McClure of Delawie, expertly guided the discussion, featuring panelists Mike Barbera of ISPE and Intersect Management, James Bassett of Arrowhead Pharmaceuticals, and Jamie Prevost of Prevost Construction. We learned so much from their expertise and discussions. Thanks to everyone who joined us and special thanks to sponsors ABM and San Diego Mechanical Energy! Stay tuned for more exciting events targeting the Life Science sector. #LifeScienceSeminar #LifeScience #IndustryExperts #BOMASD #ThrowbackThursday

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The roll out of MoCRA continues. Mandatory facility registration and product listings under the Modernization of Cosmetics Regulations Act went into effect today, July 1. Also noted that while the FDA hasn't yet provided detailed guidance related to MoCRA's safety substantiation requirements, the essence of this requirement is already in effect and fully enforceable by the FDA. Affected cosmetic companies are advised to be able to provide safety data for their products "derived from scientifically robust methods." Being able to demonstrate that your cosmetic-related facility is in a state of control has always made good business sense; now it's a regulatory requirement.

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We must take action to support the biocontrol/ biopesticide industry, which is in crisis due to the lengthy regulatory process and limited products for farmers, which are slowing adoption. This issue won't resolve itself. We need to come together and take decisive action. Are you ready? Join the WBF to unlock Exclusive Benefits and Grow Your Network! The WBF is at the forefront of advancing the agricultural Biologicals sector, offering incredible opportunities for collaboration, policy influence, and practical support for its members. If you’re passionate about shaping the future of sustainable agriculture and want to work for an innovative, impactful organization, now is the perfect time to join us! From fostering connections with industry leaders to driving national policy change, WBF empowers its members to make a real difference in #IPM, #Biopesticides, and #SustainableFarming. Don’t miss out on this chance to grow your network and access exclusive resources that support your success. Visit WBF Membership to learn more and take the next step in your BioAg journey! #Biocontrol #Agricultural #Biologicals #SustainableFarming Dr Minshad Ali Ansari | Alan Bullion | Balaji Vasudevan | Carol P. | David Shapiro-Ilan | Dean Metcalfe | Diana Leemon | Ian Cox | Kellye Eversole | Owen Jones | S. Patricia Stock | Robert Cannings | Ralf-Udo Ehlers | Shachi Gurumayum | Shashi Bhooshan Sharma | Stephen Ford | Manjunath T. M. Meraj Syeda

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📢 Check out our report on the explosive growth of the Cell and Gene Therapy (CGT) industry in Greater Philadelphia! 🌟 #LeadingLifeSciences! The region is now the nation’s #2 CGT hub, serving as home to 60 of the estimated 500 CGT companies worldwide. Dive into the report here: https://lnkd.in/edNneij9

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Release from FDA: Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program FDA will begin accepting requests to participate in year three of the CDRP on October 1, 2024. Federal Register Notice On October 31, 2022, FDA first announced the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program for Center for Biologics Evaluation and Research (CBER) - and Center for Drug Evaluation and Research (CDER) - regulated products. CBER and CDER are continuing to conduct the CDRP to facilitate CMC development of selected products under investigational new drug (IND) applications with expedited clinical development timeframes to help patients get access to these products sooner. Sponsors of INDs with accelerated clinical development timelines are invited to apply to the CDRP. On October 1, 2024, FDA will begin accepting requests from sponsors who wish to participate in year three of the CDRP. Sponsors of INDs accepted into the pilot will be able to discuss their CMC product development strategies and goals with FDA review staff during two predesignated Type B meetings. Sponsors will have an opportunity for follow-up discussions to address questions arising from the meetings or when additional clarifications are needed. This increased communication will help sponsors complete CMC activities for their accelerated drug development programs to support application submission and earlier patient access to these products. https://lnkd.in/eKXj-dTa

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Hi everyone, the disruptive nature of RNA-based therapies, relative to small molecule and biologic modalities, continues to garner investment. This recent news from Sarepta highlights the important role of the New England bio/pharma ecosystem in advancing these opportunities for patients.

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The Future Of Automation & Robotics In Cell Therapy Manufacturing https://lnkd.in/eUQS6C3b Our experts (Will Junker, Nicholas Siciliano & Erin Harris) share the specific tasks or processes within cell therapy manufacturing that are currently being automated as well as the primary objectives behind automation efforts. 

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It’s amazing to see what an improvement bioanalytical automation can have on our lab efficiency and quality! Learn more about how implementing bioanalytical automation into your study can help streamline development in my team member’s presentation: https://bit.ly/3ZVKOtv

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According to MassBio Industry Snapshot, Massachusetts added almost 3,000 net new jobs in the biopharma industry in 2023 (nearly 17% of overall job growth in MA). Learn more in this annual report that tracks the state’s life sciences industry’s growth https://lnkd.in/g3UUMhZ2

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For any laboratory operations folks (scientists that cover lab ops functions count too!) in Philly, I highly recommend this if you can go.

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Check out our OEM Enzyme selection tool! Use this interactive guide to shorten the enzyme selection process for molecular assay development. This tool helps reduce the time and effort required for you to find the right products through a series of simple questions based on analyte and application. Try it out today!

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Current CAR-T manufacturing is expensive and time-consuming. BioProcess International explores how standardization and automation can pave the way for faster, more efficient production. https://lnkd.in/g94QhfYH What do you think about the idea of bringing in personnel who know and have lived high throughput manufacturing? #manufacturing #innovation #celltherapy

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