Joseph Sullivan, P.E.

The latest U.S. Biotechnology Instruments Market report unveils remarkable growth and new opportunities. Here are 10 essential takeaways for every biotech professional: 1️⃣ Market Growth Projections: The market is set to surge from USD 36.16 billion in 2024 to an impressive USD 49.11 billion by 2033, with a CAGR of 3.46%. 2️⃣ Dominance of Analytical Instruments: Analytical instruments, holding a 65.9% market share in 2023, play a vital role in biotechnological applications, from research to quality control. 3️⃣ Rapid Growth in Cell Culture Instruments: The cell culture instruments segment is poised for the fastest growth through 2033, driven by advancements in biopharmaceuticals, regenerative medicine, and personalized healthcare. 4️⃣ Pharmaceutical & Biotech Companies Lead in End-Use: Dominating the end-use segment with a 40.11% market share in 2023, these companies showcase the industry's dedication to drug discovery and genetic engineering. 5️⃣ Rising Investment in Precision Medicine: With expanding applications, precision medicine presents substantial opportunities, boosting demand for biotechnology instruments crucial for genomic sequencing and biomarker analysis. 6️⃣ Regional Innovation Hubs: California and Massachusetts remain strongholds of biotech innovation, with emerging clusters in Texas and North Carolina contributing significantly to industry growth. 7️⃣ Addressing Regulatory Challenges: Navigating regulatory complexities, especially around gene editing and stem cell research, is crucial for sustaining innovation and market growth. 8️⃣ Global Market Size Estimates: The global biotech instruments market is projected to grow from USD 89.85 billion in 2023 to USD 132.36 billion by 2033, at a CAGR of 3.95%. 9️⃣ Recent Product Innovations: 2024 saw notable advancements, including LICORbio's Odyssey® F biomolecular imaging systems and Waters Corporation’s Alliance iS Bio HPLC System, enhancing productivity and research capabilities. 🔟 Impact of Biopharmaceutical R&D: The expansion of biopharmaceutical R&D, focusing on biologic drugs like monoclonal antibodies and cell therapies, is driving increased demand for sophisticated biotechnology instruments. For those looking to stay ahead, these insights provide a roadmap to understanding market dynamics and seizing growth opportunities. Dive into the full report for an in-depth analysis. Procure Complete Report (220+ Pages PDF with Insights, Charts, Tables, and Figures) @ https://lnkd.in/dGry4wGJ #Biotech #MarketInsights #Innovation #PrecisionMedicine #Genomics #Biopharmaceuticals #BiotechInvestments #RegulatoryAffairs #BiotechResearch #MarketGrowth Let's continue to elevate the biotech industry together! 🚀

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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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Insight into a few of the ways we're helping our customers through recent projects we’ve taken on at Nucleus Automation Partners:        “𝐈 𝐝𝐢𝐝𝐧’𝐭 𝐞𝐱𝐩𝐞𝐜𝐭 𝐭𝐡𝐚𝐭!” If you’ve ever installed software expecting it to just repair what is already there and leave your data intact, only to realize you inadvertently formatted, partitioned, or otherwise wiped the hard drive, you know the pain of this one. We helped rebuild this system – a complex array of software, drivers, and licenses, got the integrated components talking and re-imported the script to get the system back online. With some pro-active measures, we can also help future-proof you from this situation to make a recovery even simpler.         “𝐈𝐭 𝐣𝐮𝐬𝐭 𝐭𝐚𝐤𝐞𝐬 𝐭𝐨𝐨 𝐥𝐨𝐧𝐠 𝐭𝐨 𝐩𝐫𝐨𝐜𝐞𝐬𝐬 𝐚 𝐩𝐥𝐚𝐭𝐞.” We recently analyzed a customer’s existing automation scripts, took a survey of their automation resources, and identified underutilized assets already in the lab, that, in conjunction with some updated programming, can significantly reduce the plate processing time, and thus the cycle time, of their operation.         “𝐖𝐞 𝐰𝐚𝐧𝐭 𝐭𝐨 𝐦𝐚𝐤𝐞 𝐢𝐭 𝐞𝐚𝐬𝐲 𝐟𝐨𝐫 𝐨𝐮𝐫 𝐢𝐧𝐬𝐭𝐫𝐮𝐦𝐞𝐧𝐭 𝐨𝐩𝐞𝐫𝐚𝐭𝐨𝐫𝐬.” One customer is expanding their automation footprint across multiple sites. We edited their existing scripts and added graphical user interfaces that will help by providing clear visual loading instructions, providing a clean interface for entering run-time information, and provided status information throughout the various steps of the process.         “𝐖𝐞’𝐫𝐞 𝐮𝐩𝐝𝐚𝐭𝐢𝐧𝐠 𝐨𝐮𝐫 𝐋𝐈𝐌𝐒 𝐚𝐧𝐝 𝐧𝐞𝐞𝐝 𝐨𝐮𝐫 𝐥𝐢𝐪𝐮𝐢𝐝 𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐢𝐨𝐧 𝐮𝐩𝐝𝐚𝐭𝐞𝐝 𝐭𝐨𝐨.” We were just recently contacted about a liquid handler script I personally programmed going on 7+ years ago (long before Nucleus Automation Partners existed). When writing it, I interfaced their liquid handler to a LIMS system. While it’s been in routine operation for many years, a transition to a new LIMS system will necessitate updates to the script. We look forward to giving this process further life for what we hope will be another 7+ years. Nucleus Automation Partners - we provide scripting services for all major liquid handling platforms (built from the ground up or modifications to existing scripts, whether or not originally written by us), planning for new automation, LIMS/LIS interfaces, and other lab automation consulting services. On-site and remote options available with our highly experience team. #labautomation #liquidhandling #robotics #ngs #proteomics #biopharma #tecan #hamilton #lims Nucleus Automation Partners Mike Mueller Kelly Tracy 

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Nxera Pharma, formerly Sosei Heptares, is set to receive $4.6 million in milestone payments from Centessa Pharmaceuticals. Centessa licensed Nxera Pharma technology to help design its novel orexin receptor 2 (OX2R) agonist, ORX750. https://lnkd.in/eKXySM7D Nxera, which has R & D facilities in Cambridge, says the milestone was achieved with clearance of the ORX750 Investigational New Drug application and progression of ORX750 into a Phase 1 clinical trial. The drug is designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1, with potential applicability to narcolepsy type 2, idiopathic hypersomnia and other sleep-wake disorders with normal orexin levels. In-demand Nxera also reveals that it has expanded a strategic R & D partnership with PrecisionLife in a new therapeutic area. The collaboration will leverage novel insights into causal biology within auto-immune disorders to identify fresh targets for drug discovery. PrecisionLife is a Causal AI precision medicine specialist. This is the latest in a series of collaborative agreements between Nxera and PrecisionLife, which began in 2022. The partnership aims to establish new drug targets and subsequently potential precision targeted therapies for auto-immune disorders, each linked to subgroups of patients by PrecisionLife’s mechanism-based patient stratification biomarkers. Matt Barnes, EVP, President of Nxera Pharma UK and Head of R & D, said: “PrecisionLife’s platform for enabling unique insight into disease biology supports our approach to identify the ‘right’ drug target and patient subgroups to leverage our world-leading discovery and early development capabilities and increase our probability of success to provide more effective treatments for patients.”

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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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🚀 Exciting collaboration announcement! Kincell Bio and Imugene Limited have unveiled a strategic manufacturing and process development partnership, featuring the sale of Imugene's North Carolina CGMP manufacturing facility and the transfer of process and analytical development activities to Kincell. 💼 The strategic alliance includes a manufacturing supply agreement wherein Kincell will manufacture Imugene's Azer-cel to support ongoing clinical trials. Additionally, Kincell will take over the process and analytical development of Azer-cel to optimize its readiness for commercial production. 🏭 The acquisition of Imugene's 32,800-square-foot CGMP-compliant facility marks a significant milestone for Kincell, enabling them to evolve site capabilities and manufacture a broad portfolio of autologous and allogeneic products. The facility's location in Research Triangle Park (RTP) will facilitate access to talent in the fast-growing biotech hub. 🌍 This partnership underscores the commitment of both Imugene and Kincell to advancing immunocellular therapies and addressing significant unmet medical needs for patients worldwide. 🌐 #PharmaceuticalIndustry #Partnership #TherapeuticInnovation #ImmunocellularTherapies #Biotech #CDMO #Collaboration

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Interesting inphographic highlighting the technologies used by 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗖𝗗𝗠𝗢𝘀 who develop and manufacture 𝗙𝗶𝗻𝗶𝘀𝗵𝗲𝗱 𝗗𝗼𝘀𝗮𝗴𝗲 𝗙𝗼𝗿𝗺𝘀 of small molecules. 𝗧𝗢𝗣 𝟯! 🥇 Tablets (218 companies) 🥈 Capsules (192 companies) 🥉 Liquids (163 companies) 𝗞𝗲𝘆 𝘁𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀: 🧪 Increasing availability of CDMOs offering sterile glass vials over glass ampoules. 💉 Growing trend of CDMOs providing pre-filled syringes. 💊 Rise in CDMOs offering high-potency solids for Oral Solid Dosage forms. 🗜 Some CDMOs offer less common technologies such as blow fill seal amps, sterile bags, and cartridges. Full article by PharmaSource in comments... #CDMO #SmallMolecules #Pharma

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In an industry where change is ever constant, Andelyn Biosciences stands as your steadfast partner in gene therapy manufacturing. With over two decades of experience and expertise, our commitment to growth and innovation ensures we're here for you, ready to bring your groundbreaking therapies from the lab to the patient. See what a feasibility study and yield assessment can do to get your program started on a path to process industrialization: https://buff.ly/3UzqzNP #andelynbiosciences

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Here is an up-to-date list of the Commercially Available Lipid Nanoparticle (LNP) Manufacturing Equipment that is out there right now. "There are a lot of new ways to manufacture nanoparticles at the development and cGMP scales that did not exist prior to the COVID-19 pandemic. For example, Table 1 shows the results of a survey of the commercial nanoparticle manufacturing equipment market from April 2024. There are Critical Process Parameters (CPPs) associated with the control of each of these systems. Understanding their impact on the quality and efficacy of the drug substance/drug product will need to be fully defined when progressing through the development and scale-up cycles, especially when switching from one ‘technology type’ to another. Thus, it is particularly important to understand the technical and regulatory support that each equipment vendor is willing to provide when you select their manufacturing equipment to formulate your RNA-LNP. This information will need to be documented in the CMC section of your submission." https://lnkd.in/e2vreRzq #Technology #Innovation #BestAdvice #BusinessIntelligence #LNP #DDS #PharmaceuticalManufacturing #Biotechnology #DrugsPharmaceuticals #Research #GMP #cGMP #FDA #EMA #NMPA #Nanoparticles #Nanotechnology #CellTherapy #GeneTherapy

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Pharmaceutical Technology recently spoke with our SVP of Science & Technology, Parviz A. Shamlou, about the potential impact that the Biosecure Act may have on the pharmaceutical industry, as well as the progress of continuous manufacturing in #biopharma. Parviz shares, “We appreciate that [the Biosecure Act] is an important act designed to protect the health of citizens of this country. And we know we must do everything we can to avoid any unintended, potentially harmful use of our services as highlighted in the act,” says Shamlou. “Abzena has put in place a robust contingency plan as well as a CMC strategy designed to mitigate any such risk to the supply chain and the development of the assets that our customers bring to us.” Click here to listen to the interview: https://lnkd.in/eAMc4fiP #CDMO #CRO #Drugdevelopment #Supplychain

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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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My colleagues, John Puglia and AdamGoldstein, each recently spoke with BioPharm International around the benefits Single-Use Technologies (SUTs) provide in terms of process efficiencies and environmental sustainability benefits. If those piqued your interest and you want to learn more, read our recent white paper on the topic. Take a look! #bioprocessing

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As drug substance molecular complexity continues to increase, flow chemistry is becoming an essential enabling technology. Chemical methods once restricted to the discovery laboratory can be available for use in clinical and commercial manufacturing because of this technology. Join our Chief Scientific Officer, Matthew Bio, in a live webinar on June 13th via Outsourced Pharma as he discusses examples of the use of flow technology to enable modern synthetic methods from pilot-scale through commercial. https://lnkd.in/grTwi_-G #continuousflow #flowchemistry #pharmaceuticals

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𝗗𝗮𝗶𝗹𝘆 𝗡𝗲𝘂𝗿𝗼-𝗯𝗶𝘁𝗲𝘀 🧠: 💵𝘾𝙤𝙣𝙜𝙧𝙖𝙩𝙪𝙡𝙖𝙩𝙞𝙤𝙣𝙨 to CereVasc who secures $70 million series B financing, following FDA approval of STRIDE study 𝗦𝗼, 𝘄𝗵𝗮𝘁 𝗮𝗿𝗲 𝘁𝗵𝗲𝘆 𝗴𝗼𝗶𝗻𝗴 𝘁𝗼 𝘂𝘀𝗲 𝘁𝗵𝗶𝘀 𝗳𝘂𝗻𝗱𝗶𝗻𝗴 𝗳𝗼𝗿? 🧑‍💻Support the clinical and regulatory development of the company’s novel eShunt system ⚕️Fund their upcoming STRIDE pivotal study involving patients with normal-pressure hydrocephalus. 🤔𝗪𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝘁𝗵𝗲𝗶𝗿 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗱𝗼? Their eShunt System is a minimally invasive approach to treating hydrocephalus. The System comprises an endovascularly implantable CSF shunt and associated delivery component. This is designed to avoid the need for: ⭐Invasive surgery ⭐General anesthesia ⭐Extended hospitalization ⭐Post-procedure pain management. #hydrocephalus #brainhealth #minimallyinvasive #patientoutcomes #neurovascular https://lnkd.in/e-R5wkkQ https://lnkd.in/enfjKs_E

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If you gave the same molecule to two different companies before Phase 1, would they be equally successful? I'll explain why the answer is "No" during my talk next Thursday at the ISPE Greater Los Angeles Area Chapter Vendor Night Technical Session, and also covering the impact AI/ML is having on Drug Development. Register for the event here if you haven't already! Information can be found in the link below, and also credit to IDEA Pharma on the thought-provoking question.

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Check out this article on the struggles of biomfg to hire highly skilled talent with the specialized skills needed to work in this industry! If any industry needs skills-based hiring now, it's biomanufacturing. This is why we do our work at BCSI. Our microcredentials shine a bright light on the skills so desperately needed in this dynamic sector.

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Next-generation drug products require next-generation partnerships. In our latest on-demand webinar, Anil Kane, Ph.D., MBA, Senior Director of Global Technical Affairs at Thermo Fisher Scientific, shares his views on the critical importance of strategic #CDMO partnerships in reshaping #drugdevelopment, emphasizing the need for #innovation, #adaptability, and true operational #agility to meet the complex challenges of the evolving pharmaceutical landscape. From novel partnership models to integrated supply chain management to #dataanalytics and AI-based #predictivemodeling, these innovations are transforming pharma manufacturing. Watch our on-demand webinar to see how a strategic CDMO partnership can elevate your next project: http://spr.ly/6042eDEsi

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