Guillermo Viramontes

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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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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Interesting trend: a federal judge on Monday just threw out BMS and J&J's challenges to the drug price negotiations outlined in Inflation Reduction Act. Given the 9 year patent protection for small molecules compared to the 13 year protection for biologics, it seems like investments for biologics will continue to gain traction. Biologics received 30% more funding than small molecules in 2022, and 50% more investment in 2023. Something to consider if you're looking for "stability" at your next employer in the Biotech/Pharma space.

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

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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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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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Happening at 12PM - Abstract Number 960! Don't miss insights from our cell and gene therapy scientist, Katie Knapp! 🧬 Learn about GMP Testing Potential for Replication Competent Adeno-Associated Virus Across Multiple Serotypes! Meet our team at ASGCT booth #2253 this week! #eurofins #testingforlife #vectorology #virology

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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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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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The Center for Biocatalysis and Bioprocessing's cGMP Facility is capable of producing protein products for Phase-1 clinical trials. This facility strictly follows the 2008 FDA guidance for cGMP manufacturing of materials for Phase-1 investigational drugs. All cGMP projects are run by our full-time, professional staff with years of manufacturing experience. Say Hi to our amazing GMP Project Manager, Sarah Kasperbauer! Sarah received her B.S. in Biology with a minor in Chemistry from Marymount College of Fordham University in New York. In 1999, she started working as an intern at Acorda Therapeutics, New York, and continued her work there until 2009, during which she focused on mammalian cell culture and protein purification. Sarah came back to Iowa, her home state, in 2009 to join the CBB, where she is currently the GMP Project Manager. Outside of work, Sarah is occupied raising a young son and taking care of her acreage, but, despite her busy schedule, she enjoys spending quality time with family and friends. Don't forget to click that "Follow" button to hear more about our awesome team at the CBB! The CBB is a unit within the Office of Vice President for Research (University of Iowa Research) at the University of Iowa. Please visit https://uiowa.edu/ to learn more. #scientists #science #scientist #lifesciences #research #biotech #biotechnology #biotechnologystudent #biotechinnovation #biotechindustry #biotechnologyindustry #researchanddevelopment #researchers #biology #biochemistry #biophysics #molecularbiology #cellbiology #biocatalysis #bioprocessing #pharma #pharmaceutical #pharmaceuticals #pharmaceuticalindustry #pharmaindustry #oncology #radiationoncology #dna #proteinexpression #proteinpurification #highereducation #fellowship #fellowships #nih #nsf #nsffunded

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Today's #cyclodextrin update highlights the importance of Ultrafiltration/diafiltration (UF/DF) in biotherapeutic downstream processing. However, traditional UF/DF processes can be time-consuming and cause protein exposure to physical stresses, leading to particle formation. Fortunately, hydroxypropyl ß-cyclodextrin (KLEPTOSE® HPB from Roquette) has been shown to protect proteins and reduce particle formation during UF/DF. In addition, KLEPTOSE® HPB's permeability in PES membrane allows for its usage without affecting concentration. This multifunctional excipient has promising potential for biotherapeutic bioprocessing and formulation. https://lnkd.in/d5viGXV7 #bioprocessing #biotherapeutics

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Are you experiencing Upstream Process Development screening capacity constraints? Leverage Culture Biosciences’ cloud-connected bioreactors to accelerate your project. #processdevelopment #processoptimization #cloudconnectivity #bioreactor #bioprocess

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cGMP + GMP vs. non-GMP sample storage- does it really matter? YES! Current Good Manufacturing Practices (cGMP) and GMP are guidelines written by the U.S. FDA to ensure drugs, pharmaceuticals and more meet minimum safety and quality standards for use as intended. All SciSafe facilities are fully cGMP compliant and accredited to industry standards for pharmaceutical, component and biologic storage. By choosing SciSafe to store any non-GMP samples, you are gaining the additional benefit of these strict handling standards at no extra cost to your organization. Stay tuned for an upcoming white paper comparing GMP and other industry standards. #outsourcedstorage #GMP #cGMP #samplestorage #researchstorage

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Our next webinar, with Dr. Samantha Atkinson from NSF, looks at how a quality culture can positively impact GMP compliance which, in turn, can impact supply chains and GMP compliance. - https://bit.ly/3KWIKbX

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While advanced drug formulations continue to grow more complex each day, oral solid dosage (OSD) forms still remain one of the most common and effective drug formulation types. Orally administered pharmaceuticals, which include pills, tablets, chewables, and capsules, remain the preeminent drug delivery form due to several advantages including: ✅ Patient accessibility ✅ Cost ✅ Consistent dosing and drug content ✅ Long shelf lives What drug formulation type is your company engaged with? What were the factors driving your decision? Learn about how TriRx Pharmaceutical Services, LLC can help advance your OSD program: https://lnkd.in/gX2Qs5Ni #pharma #healthcare #drugdevelopment #cdmo

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