Marc Franzini

In #biologics manufacturing, Single-Use Technologies (SUTs) provide a multitude of advantages from the flexibility to scale up or scale down, to reduced downtime needed for cleaning, sterilization, and maintenance. Our colleague, Adam Goldstein, recently had the opportunity to share some insights with BioPharm International on SUTs and the characteristics of this technology that are influencing adoption throughout the industry. Check out the full article to learn more about incorporating SUTs into your workflow. #bioprocessing

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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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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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Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot 600 supports scale-up from process development to GMP clinical scale. Try this ÄKTA system in 3D https://cytiva.link/fajey

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Join me and my esteemed colleagues on June 12th for our LIVE virtual Planova Operators Course! Learn about the importance of virus filtration and how to use our commercially available next-gen virus filter, from the pioneers who brought the first virus filter to the market. Register for this FREE course using the link below, see you there!

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Get ready for Episode 7 of the GxPodcast! 🎙️ This week, we're joined by Chris Lewis, the Vice President of GMP Quality for Umoja Biopharma. Tune in to hear us discuss quality culture and excellence in life sciences. We look at cell and gene manufacturing, the connection between innovation and purpose, and the importance of data management in our industry. Tune in to the full episode here: 🔗 https://lnkd.in/exW4jkBB #GXPodcast #iPharmGxP

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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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AmplifyBio is doing things differently in CRO and CDMO space. Offering phase appropriate scale up solutions in advanced therapies - partners can outsource services at any point, from concept to commercial. If you are involved in a scaling program, let's get our teams together. It's never too early to plan. #advancedtherapies #mrna #cdmo #celltherapy

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Check out our latest project and how it will help us to help you better and faster!

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Check out David Powell talking all things Annex 1, what it means to have the answers to the test, and GRAM's recently announced expansion plans. And of course, my cameo at 0:28 😂! These things really matter, and GRAM is ahead of the curve. Drop me a note if you understand the "why" and want to discuss further.

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☕ #Boston, grab you favorite Dunkin’ coffee and join us at the Precision in Clinical Trials Summit May 6 & 7! Stop by Booth #11 to meet the #IDDI experts Tara Kervin & Kalyn D. to discuss how IDDI’s solutions can assist your most pressing clinical trial challenges. 📈 Schedule a meeting today: https://lnkd.in/efjcJffp #PCTSummit #biometricscro #clinicaltrials #biostatistics #datamanagement #lifesciences #trialdesign

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We Are GMP Pros, Inc.® Our approach is different. We lead change from the inside out with a team of technical experts and savvy strategists who know how to navigate FDA-regulated manufacturing. We work person-to-person with your team to offer immediate support, while also building the structures to support long-term change. #manufacturing #fda #engineering #biotechnology #pharma #animalhealth #food

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⬇ Good things just got even better! ⬇ ✔ Expertise and excellence in plasmid manufacturing. ✔ Expertise and excellence in IVT. ✔ Expertise and excellence in analytics. ✔ Streamlined manufacturing. ✔ Single quality system; single facility. ✔ Now - flexibility in encapsulation platforms! How can Aldevron advance your mRNA therapeutic or vaccine candidate?

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Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot 600 supports scale-up from process development to GMP clinical scale. Try this ÄKTA system in 3D https://lnkd.in/gkYFvSwu

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

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Join my colleagues in presenting our new automated TFF system combined with Variable UV Pathlength Technology. Registration link below

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Wondering if organ-on-a-chip (OOC) technology is right for your processes? Check out this article for an honest perspective on common misconceptions and adoption challenges, and learn if OOC can really benefit your research. #ooc #organonachip Link to the article: https://lnkd.in/eU7BJU-m

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📣 Exciting DAY 1 at ASGCT #ASGCT2024 in Baltimore, MD It is great to see all the excitement within the gene and cell therapy industry. Come by Booth # 2137 and meet the team 🤝 and check out the FlexiPro TFF system. https://lnkd.in/ep5irZpy 💡Learn how our downstream purification solutions can accelerate your scale-up and commercial manufacturing. #verdot I #ASGCT2024 I #biopharmaceuticals I #innovation I #bioprocessing I #singleuse I #chromatography I #tff I #purification

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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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