William (Will) Pedrotti

Do you have a #nyone or #cellavista from SYNENTEC? Join our webinar to hear about YT-REPORTS a brand NEW software feature to make reporting a breeze. Sign up below!

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Are you navigating the complex landscape of sourcing #leukopaks and cellular starting materials for your advanced therapies?     Join us for an on-demand webinar where Matt Chorley, Parijat Jain PhD, and Wini Luty dive into crucial considerations including GMP/GTP compliance and GMP material sourcing efficiency. Gain insights into how to select the right suppliers and streamline your journey through the #CellAndGeneTherapy development pipeline: https://lnkd.in/gZtjSASx     #FDARegulation #CellTherapy #GeneTherapy

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Demonstrating the technical leadership of SK pharmteco! 🧬 Catch up with our team at ASGCT to discuss how SKPT can support your #cellandgene development!

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No one should have to redo experiments because they couldn’t find the data they need. Eliminate siloed data by standardizing and centralizing your data at every stage of your process development cycle. See how #BenchlingBioprocess can help: https://lnkd.in/eXdAwK_P

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As NAMs are becoming more relevant and accessible in today’s chemical product development, Labcorp is innovating in vitro alternatives so clients around the globe can leverage these new assays. From standard techniques to novel solutions, we can identify an approach that fits your product’s specific regulatory requirements. Discover your NAM options today. #CropProtection #ChemicalDevelopment #InVitroStudyAlternatives #NewApproachMethodologies #NAMs

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Through database building, EAG provides higher-quality chemical characterization reports with reduced turnaround times to support medical device biocompatibility programs. Learn more in the recent whitepaper authored by Drs. David Black and Steve Doonan: https://lnkd.in/gpCPmvPY #medicaldevice #extractableleachable #chemicalcharacterization #toxicology #ISO10993 #ISO21726

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Check out this report from Drug Development & Delivery #Pharma #Biotech #CDMO #Formulation #DrugDevelopment #DrugManufacturing

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Thoughts on this? >> Cellular Origins Partners with CGT Catapult on Automated CGT Manufacturing - BioPharm International >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #biotech #competitivemarketing #pharma #healthcare

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Struggling with managing biological samples in life sciences? Check out Erica Waller's article, "Overcoming Obstacles in Automating Cryogenic Storage." ◾ Learn how a single sample's quality can impact new drugs and therapies. ◾ Discover strategies for transitioning to automated storage systems to improve efficiency and reduce errors. ◾ Understand the importance of scalable storage solutions for optimizing lab operations. 👉 Read the full article to transform your sample management! https://hubs.ly/Q02xwgQP0 #CryogenicStorage #LifeSciences #Automation #SampleManagement

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Unlock the Power of DSI's Quality Team! Dive deep into our unparalleled expertise in medical device cGMP, API, and Drug Product compliance. From aseptic processing to analytical chemistry, we ensure excellence in every aspect. #QualityAssurance #Compliance #DSI

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One more week! Don't miss our webinar on May 22 at 11 a.m. - Key Considerations when Choosing a GMP Storage Provider. Hear from Alcami experts Robert Briggs, Emily Lyon, Sylvan Poeckh, and Michael Davanzo to discuss how to ensure compliance, prepare for emergencies, and learn the benefits of considering additional services like aliquoting and cold chain transportation. Register today➡️https://lnkd.in/daQ6ewU3 #phramastorage #webinar #pharmaceuticals #coldchain #stability #GMP #storagesolutions

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BDRA Consulting LLC has been a member of AMDM since 2013. Come join AMDM for the entire story. Twice a year, members get to meet with the FDA to discuss upcoming regulatory and quality policies. The FDA provides industry updates. This year's meeting was held at Building 66, White Oak campus on May 21, 2024. Key Takeaways from the May 2024 AMDM Industry FDA Roundtable: 1. Cybersecurity for medical devices is a key issue. OHT7 and CDRH have increased focus on cybersecurity for medical devices. 2. The Oncology Diagnostic Pilot Program is nearly a year old, and no company has been accepted. This is primarily because drug manufacturers have not been able to provide validation data. 3. Reclassification plans for companion diagnostics are ongoing and will be completed by November 2027. - FDA is considering down-classifying three types of CDxʼs: i. Nucleic acid-based CDX ii. In situ hybridization-based CDX iii. Immuno-histochemistry-based CDX - Technologies will be grouped based on the intended use. 4. PCCP guidance for medical devices will be published before the end of the fiscal year 2024. A PCCP may be used to make changes to sample type changes, which may be acceptable in certain cases. 5. QSIT is being replaced by an entirely novel risk-based approach, which is currently being worked out. Manufacturers should be working through transition plans. #AMDM

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One more week! Don't miss our webinar on May 22 at 11 a.m. - Key Considerations when Choosing a GMP Storage Provider. Hear from Alcami experts Robert Briggs, Emily Lyon, Sylvan Poeckh, and Michael Davanzo to discuss how to ensure compliance, prepare for emergencies, and learn the benefits of considering additional services like aliquoting and cold chain transportation. Register today➡️https://lnkd.in/eB33R-uP #phramastorage #webinar #pharmaceuticals #coldchain #stability #GMP #storagesolutions

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Learn more about how to successfully scale-up with Thermo Fisher Scientific's latest application note, "DynaDrive S.U.B. Part 1: Intuitive bioprocess scale-up from bench scale to pilot scale." Gain valuable insights into how the DynaDrive S.U.B. outperforms bench-scale bioreactors in IgG titer, specific productivity, and cell density. Download the app note now to unlock the secrets of seamless scale-up! #bioprocessing #biotechnology #thermofisher #bioreactor #scaleup #DynaDrive

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Learn more about how to successfully scale-up with Thermo Fisher Scientific's latest application note, "DynaDrive S.U.B. Part 1: Intuitive bioprocess scale-up from bench scale to pilot scale." Get valuable insights into how the DynaDrive S.U.B. outperforms bench-scale bioreactors in IgG titer, specific productivity, and cell density. Download the app note now to unlock the secrets of seamless scale-up!  #bioprocessing #biotechnology #thermofisher #bioreactor #scaleup #DynaDrive

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Discover how a deep understanding of process characterization can drive successful clinical phases and accelerate commercial launch of biological drug development. Catalent Biologics experts share their insights here. https://ow.ly/EOEC50RqZIO

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