William Deicher

Here's a question for your Monday - just before lunch time in this time zone. What is something that China and California have in common this morning? The answer here is that both have food companies that have earned warning letters from the US FDA. Full disclosure - the excerpt in the image is from Violation 3c and 4 from the California letter. (At first I thought it was to a firm in Australia, but with an address in Brisbane, can you blame me for that? ... Well, of course you can.) As you can see, it was / is 'potentially shocking - at least in terms of anyone needing a charge from chocolate? And these letters are provided in large excerpts from FSN (Food Safety News), dated 13 MAY 2024. The link to the article is provided at the end of this post. Here is an excerpt from the letter to the Chinese company, in violation 2: i. A live insect was observed crawling inside the facility’s post-heat treatment packaging room for their RTE soy protein products. ii. Three live crawling insects and two dead insects were observed on the floor of their spray dryer room, which is directly adjacent and connected to their post-heat treatment packaging room. iii. A gap was observed at the bottom of the packaging room entry doors. And so, as you can see, the FDA investigator was definitely 'bugged' by what they saw. (Apologies for the American English pun) At this point let's suggest you probably (?) want to read the article and the letter excerpts more fully. Here's the link to the FSN article: https://lnkd.in/g8cpgEwe And now on into the week for your reading time - maybe not close a meal time however? #fda #cgmp #hazardanalysis #China #California

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I shared it before, but this guide is so good on magnetic beads that is worth for you to take a look: Magnetic beads (or superparamagnetic particles) are versatile little tools for easy and effective isolation of biomolecules. Read Magbeads 101: A guide to choosing and using magnetic beads, to compare the different surface chemistries and find the best bead for your application. We have a bead for every need! https://cytiva.link/altrz

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Full:empty ratios aren't good enough. Partials are something you can't ignore. FDA requirements will only get more stringent.  Stay ahead of the curve. You'll need a single device that can precisely measure all 3 types of AAV on a single plate. And if it can do that with crude samples, even better. That's what the Tessie can do for you.  - Full partial empty ratios (with titers) - Precise results from crude sample - Readings in less than 4 hours If you'd like to learn more, you can: 1. Send me a DM, or... 2. Book a 15-minute exploratory meeting: https://lnkd.in/gGJkVZzV #biotechnology #genetherapy #aav #innovation

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Does your biologics stay where they should be? Here, we’re packing NanoFUSE Biologics Putty inside an ACIFT Solofuse PEEK standalone cage in a one-level ACDF. Love how it fills the entire cage and stays exactly where it’s needed for fusion. Get to know NanoFUSE Biologics Putty, the ONLY flowable FDA-approved combination of synthetic bioactive glass and DBM, that is: -Osteoconductive, Osteoinductive, Osteopromotive and Antimicrobial. -Fills bone voids or defects regardless of shape or size. -Less risk of migration from desired site. Innovating the future of spine technologies. Invest. Become an owner ! www.KICVentures.com www.NANISX.com Join our LESS movement. LESS Exposure Advanced Spine Technologies (LEAST) are unique technologies invented for the LESS Exposure Spine Surgery (LESS) movement. NANISX KIC Ventures FacetFuse Sacrix NanoFUSE Biologics Inspan Sagitechnology LESS Spine MISquito AxioMed #LESS #Spine #Surgery #exposure #lessexposurespinesurgery #technologies #fusion #backpain #implant #innovation #BoneHealing #biologics #bonegraft #fusion #orthopedics #spine #orthopedicsurgery #fractures #unique #technologyinnovation #ACDF #cervicalfusion This post is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities.

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❓"Well, we've always done it this way so what's your problem"❓ Here's a deep-dive into my recent post about things 𝗻𝗲𝘃𝗲𝗿 to say to an FDA Investigator (🔗 https://lnkd.in/e-27Bn-W) On this fun new episode of Yan Kugel's Qualitalks podcast, I share real-world strategies and best practices to navigate FDA inspections with: ✅ Professionalism ✅ Compliance ✅ Proactive mindset 📺 In this clip, we discuss the 𝗺𝗶𝗻𝗱𝘀𝗲𝘁 behind why some still use this phrase. You can watch or listen to the entire discussion across several channels.🎙 Check the comments below ⬇ to access the channel of your choice. I hope you enjoy! And don't forget to give Yan Kugel a follow for more great content! ...and a HUGE congrats to Yan for recently hitting 30K followers on LinkedIn 🚀 ~~~ If you found this interesting or helpful, consider Reposting 🔄; follow me Vincent F. Cafiso and click the 🔔 so you don't miss future content.

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🧩𝐖𝐡𝐲 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 𝐌𝐚𝐭𝐭𝐞𝐫𝐬 – 𝐘𝐨𝐮𝐫 𝐏𝐫𝐨𝐝𝐮𝐜𝐭 (𝐏𝐚𝐫𝐭 𝟏) 🎯 Your startup's regulatory strategy matters because your product matters. Over the last 3 weeks we looked at what regulatory professionals do - balancing leadership and ethics with cross-functional expertise and technical skills. This week we'll look at why the strategy your regulatory team develops is critical to getting your product to market. Each medical device is unique and deserves a tailored assessment of what regulatory requirements are relevant and how to show compliance to them. In my presentation at Alberta’s Life Sciences Week I highlighted a key reason why regulatory strategy matters: because your product matters - you want to sell it, help people, and drive your business forward. 𝐀𝐥𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬 𝐀𝐫𝐞 𝐍𝐎𝐓 𝐂𝐫𝐞𝐚𝐭𝐞𝐝 𝐄𝐪𝐮𝐚𝐥: Each product has a unique combination of technologies, applications, use environments, and users, resulting in a unique risk profile. As the risk of your product increases, you will need to engage with more experts and generate more evidence to prove your product does what you say it will in a way that is safe and effective. 𝐌𝐨𝐫𝐞 𝐑𝐢𝐬𝐤 = 𝐌𝐨𝐫𝐞 𝐑𝐞𝐬𝐨𝐮𝐫𝐜𝐞𝐬: Higher-risk products need more time and money to engage those experts and generate that evidence to successfully navigate the regulatory landscape. Not knowing about and planning for these resources can lead to delayed approvals, disappointed patients, and disgruntled investors. 𝐍𝐨 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 = 𝐍𝐨 𝐌𝐚𝐫𝐤𝐞𝐭 𝐄𝐧𝐭𝐫𝐲: Your product can’t go to market anywhere until you have all the evidence and regulatory go-ahead to show it is safe and effective. Involving your regulatory team early on helps avoid costly delays. 🗝 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲: The more complex and risky your product is, the more important it becomes to start your regulatory strategy and planning early. ☎ 𝐂𝐚𝐥𝐥 𝐭𝐨 𝐀𝐜𝐭𝐢𝐨𝐧: What steps is your startup taking to develop and build a compliant product from the beginning? Stay tuned next week when we explore why regulatory strategy isn't just about your product - it's also about your company's long term success 👀 𝐏.𝐒. 𝐃𝐢𝐝 𝐲𝐨𝐮 𝐦𝐢𝐬𝐬 𝐭𝐡𝐞 𝐞𝐚𝐫𝐥𝐢𝐞𝐫 𝐩𝐨𝐬𝐭𝐬 𝐢𝐧 𝐭𝐡𝐢𝐬 𝐬𝐞𝐫𝐢𝐞𝐬? 𝐂𝐡𝐞𝐜𝐤 𝐭𝐡𝐞𝐦 𝐨𝐮𝐭 𝐡𝐞𝐫𝐞: ❶ Leadership and Ethics: https://lnkd.in/gTf-jMn7 ❷ Cross-functional Expertise: https://lnkd.in/gzc3vmxm ❸ Technical Skills: https://lnkd.in/g-2aPxNu #LifeSciencesWeek #MedicalDevices #Innovation #MedTech #RegulatoryAffairs #Startups #RegulatoryCompliance #RegulatoryStrategy #RiskManagement

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✊ Phage Against the Machine It’s less to do with regulation. It’s more of a capitalism thing! And a manufacturing practices thing. And a research thing. And a safety thing. It’s complicated! I bumped into Ben Temperton at Citizen Phage Library a little while back. Ben told me about something going on in Parliament where scientists and UK’s Science, Innovation and Technology Committee (SITC), and others, are flying the flag for phage research. Since then I’ve been telling everybody about the awesome potential of Phage therapy, and I’ve been dying to write a blog! So…. I got started on the blog, with subtitles like, ‘What the phuck is phage?’, ‘How do they work?’, ‘What’s so cool about phage’? I wanted to include summaries of all of the challenges and the work going on with the Phage Policy Paper and the Government’s response to the Policy. And it’s really interesting. But it's pretty complicated for a blog. So I did what I did best…. Abandon the blog and design a t-shirt! And then I took my unfinished blog. I took SITC’s paper, ‘The antimicrobial potential of bacteriophages’. And I got Gemini 1.5 (thanks Google) to compile this podcast. What do you think?! About me I’m CEO of @Singer Instruments, making robots to accelerate biological research. At the moment I’m really keen to work with somebody to see if we can help accelerate phage and bacterial isolation, phage library generation and screening. Oh, and if you disagree with anything I’ve done here, please let me know. I’ve got a growth mindset! Phage Against the Machine t-shirt, anyone!? Thanks Tim Logg for the graphics! #Phage #PhageTherapy #Bacteriophage #AMR #AntimicrobialResistance #Microbiology #Biotechnology #Robotics #DrugDiscovery #PersonalisedMedicine #OneHealth #Innovation #Research #Science #ExeterUni #CitizenScience

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Good overview of the impact of the LDT rule.

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Streamline your productivity with Niagara Launcher! Discover the minimalist launcher that's taking Android devices by storm! In a world of cluttered home screens, Niagara Launcher's simplicity shines. Learn from its creator, Peter Huber, on how this innovative app boosts focus and efficiency. [https://lnkd.in/eYC5fNqt] Key features: Simplistic design for reduced distractions Effortless navigation and customization Improved battery life Upgrade your mobile experience! Download Niagara Launcher and: Regain control over your screen Enhance your workflow Save time Join the productivity revolution! Share your favorite productivity hacks in the comments! #ProductivityTools #NiagaraLauncher #Android #Minimalism #Efficiency

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"San Diago... which of course in German means..." (you can fill in the blank in your head if you know the reference 😂) But I AM in gorgeous San Diego! Please reach out if you've been curious about base editing and would like to have an in person seminar in the So Cal region this month! Why base editing for your therapeutic cell engineering pipelines? ⏲️ SAVE TIME- reduce timelines on multiplex edited cell products by up to 90% 💰 SAVE ON COSTS of manufacturing when less steps are required to reach the end product 💪 HEALTHIER CELL PRODUCTS - gene editing with our platform avoids double strand DNA breaks, reducing the risk of genomic translocations, reducing cytotoxicity, and supporting normal growth rates

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Congratulations to my colleagues on receiving U.S. Food and Drug Administration (FDA) 510 (k) clearance of Thermo Fisher Scientific’s SeCore HLA Typing Kit for use as a companion diagnostic with a T-cell receptor (TCR) therapy for Synovial Sarcoma. Synovial sarcoma is a rare form of soft tissue cancer with a 36% survival rate. It most commonly affects young adults. The FDA’s clearance of our SeCore CDx HLA A Sequencing System as a companion diagnostic can offer patients and families new hope. The test can now be used to identify patients who may benefit from a first-of-its kind TCR therapy. The members of Thermo Fisher Scientific’s Quality & Regulatory Affairs function who worked on securing FDA clearance were proud to be a part of the effort to bring this innovation to patients with synovial sarcoma. Cancer immunotherapies, including TCR therapies, have become increasingly powerful tools in cancer treatment, particularly for patients with metastatic or unresectable tumors. TCRs interact with specific human leukocyte antigen (HLA) proteins to activate an immune response, making high-resolution HLA typing a critical step in identifying patients most likely to benefit from engineered TCR therapies like TECELRA. TECELRA (afamitresgene autoleucel) is Adaptimmune’s newly approved TCR therapy for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy. While the origins of HLA typing are most closely associated with transplant diagnostics, a critical component of matching patients and donors to reduce the risk of immune-mediated rejection, HLA proteins have wide-reaching effects on the immune system and may play a role in many immune-mediated conditions. Thermo Fisher’s Transplant Diagnostics business is committed to leveraging its history of innovation in immunology to help customers develop novel treatments that enable better patient outcomes, regardless of therapeutic area. #QualityProfessionals #QualityAssurance #RegulatoryAffairs #QARA #Regulatory #Quality #QualityControl #SynovialSarcoma #CancerTreatment #TCellTherapy #TCR #Tecelra #targetedoncology

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digiM's recent FDA IDIQ contract award marks a big step in advancing the role of microstructure analysis in regulatory assessment for complex generics. This partnership is set to deepen industry knowledge around product quality attributes and release mechanisms in key drug products, from injectables to implants. This recognition highlights the growing impact of microstructure tools like 3D microscopy and AI-based modeling, demonstrating how essential microstructure science is becoming within the pharmaceutical industry. https://lnkd.in/d5sj5Eds

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Full disclosure, I am several 483s (plus other items) behind in posting - and perhaps you are grateful for that? In any event, this latest OUS 483 dated 23 APR 2024, was one I had wanted to post about last week due to the 'local press [ https://lnkd.in/eks5skDz ] . But I decided to wait and see what happened and something did - the actual 483 was posted mid-day today. It certainly put flesh on the bare bones of the article - "the USFDA conducted an inspection at the injectable manufacturing site .... The inspection closed with 10 observations", There were 10 observations indeed -spread over 18 pages. The image below was 'only the 10th.' You know this was my favorite GMP sections, but when this observation around data integrity (and CSV) comes last - don't you want to see the first 9? Some teasers - Obs. 1 was over 7 pages about incomplete or inadequate investigations. Obs. 2 was about to failutr follow sampling plans for another 3 pages, followed by a brief Obs. 3 about microbiological issues. And you will find a long Obs. 5 about procedures or the lack thereof. If those jottings don't encourage you to read the full document, consider the signature line - this is the work product of the team of "Boyd and Shields." There is no surprise that it is lengthy and detailed. And given the 483 posted about in this space recently for this firm, as in just 2 weeks ago today, [ https://lnkd.in/eGHu5XHk] it is not perhaps surprising that they had "a lot to work with"? Enough of my wanderings, here is the link - read and evaluate the situation for yourselves: https://lnkd.in/eMwPQHiU Comments and questions are always welcome. It really should be good reading, at least I think so. #fda #dataintegrity #sterilemanufacturing #moda

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Tired of 'melt and drip' fat analyzers? Don’t have the time to wait up to 3 minutes per sample? Check out our newest analyzer - ChemWiz-Meat. How is this different from the ChemWiz-ADK? Find out more at the link below!

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Core values are an essental part of the nature of a team. The core values represent those ideals that form the fabric of the organization and are referred to when decisions are to be made. CART did an exercise to get input from all members of the department on what they felt were our core values. the department wad broken up into smaller groups and asked to identify what they felt were our core values. these were then shared with the group and everyone voted on their top 3 values. Based on that meeting and some refinement, we now have a set of five core values that we can use when making decisions as to department priorities, goals and more. #CART #URresearch #teamscience #URMC

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Ever found yourself facing unexpected hurdles when trying to rapidly scale your biotech or medtech operations to meet increasing demand? If so, you're not alone. In my experience at Accumold, I've observed numerous high-performing engineering teams encountering similar challenges. For all of you high-performing biotech / medtech engineers, R&D and strategic supply chain managers, there will come a time you need to scale fast to meet demand spikes. Here's what happens... Analyzing hundreds of successful rapid-scale projects in my work at Accumold, there are a few patterns you need to know and moves you can make now to anticipate equipment limitations, supply chain disruptions, workforce capacity constraints, and quality control issues. Many engineers came to us facing bottlenecks from insert vendors, material shortages, and quality control issues when scaling. Re: insert vendors: they run into bottlenecks due to limited capacity or lead times, which can slow down production schedules. Additionally, variations in insert quality or compatibility issues may arise, affecting the overall assembly process. We anticipate this by building an extensive network with reliable insert vendors in advance. Close collaboration with these players ensures timely delivery, consistent quality, avoiding compatibility concerns. (A big deal in our micro world.) Re: material shortages: this really hurts production timelines, putting you in a position to compromise product quality, production downtime, increased costs, missed deadlines, and loss of revenue. I've noticed our team works with our suppliers to forecast material availability and anticipate these potential shortages. Expertise in material selection/sourcing allows us to offer alternative materials or recommend inventory management strategies. One final note... when scaling production to meet increasing demand, quality control must remain a focus area. Because we're the sole micro molding partner for a large percentage of our customers—we have to get this right. Rapid scaling without a plan will strain existing quality control processes, leading to inconsistencies or defects in the final product. Unrelenting quality control measures are a big deal. I'll write up more on this and post. The final word here is this: Successful engineering teams like yours should conduct thorough risk assessments, develop contingency plans, and establish clear communication channels with all stakeholders to address any unforeseen issues swiftly and effectively. What did I miss? What challenges have you run into when rapidly scaling? #SupplyChainManagement #QualityControl #CollaborativePartnerships #MicroMolding #Accumold

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Interesting listen: 'In Praise of Maintenance' from the Freakonomics podcast, which reminded me of the vital work of sustaining on-market products. New product development is just the beginning of the lifecycle - post-launch challenges, like supplier issues, stability concerns, or software bugs, can arise and need addressing even while NPD continues. Ensuring consistent, reliable supply and performance is crucial, especially for IVD customers who rely on validated products. 'Maintenance' is key to keeping the show on the road! #ProductDevelopment #Maintenance #Sustaining #IVD (Particular shout out to Manjula Chelliserry and everyone who has ever contributed to sustaining efforts)

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Come visit SwRI at SupplySide West. learn about micro and nano encapsulation

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