Christopher Deitz

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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Lonza, Busy with Capacity Upgrades and Exec Turnover, Hints at CDMO Industry Rebound A tough biotech funding environment and a downturn in COVID-related contracts has weighed heavily on CDMOs of all stripes in recent years. Now, with a new CEO waiting in the wings, Swiss manufacturing juggernaut Lonza is attempting to reassure the market that an industry stabilization is on the horizon. Despite “softer” sales over the first three months of 2024, Lonza remains confident that its performance across the first half of the year will improve to align with its full 12-month trajectory, the company said in a quarterly update this week. The company did not provide specific sales numbers for the quarter but instead gave a "qualitative" update to the market. For the first quarter, Lonza says it enjoyed sustained demand for commercial-stage projects and cited “initial signs" of an industry recovery for early-stage work. https://lnkd.in/dvK--9rg #aspenalert #biotech #bioprocess

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🔬 Big News Alert! 🔬 🌟 FDA, EPA, and USDA join forces to streamline regulation for biotech products! 🌟 Interesting times ahead for the biotech industry as these agencies collaborate to simplify pathways to market while maintaining rigorous safety standards. How do you think this will shape the future of biotech? 💥 #Biotech #Regulation #Innovation #FDA #EPA #USDA

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

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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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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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🦠 Bristol Myers Squibb (BMS) and Cellares announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies in a transaction valued up to $380M. Cellares will optimize, automate, and tech-transfer select BMS CAR T cell therapies onto its automated and high-throughput manufacturing platform, the Cell Shuttle™. Cellares will dedicate multiple Cell Shuttle and Cell Q™ systems with fully automated, high-throughput quality control for BMS’ exclusive use. This strengthens BMS’ existing global network of cell therapy manufacturing facilities and provides increased agility, improved scalability and potential to improve turnaround time to support the company’s CAR T inline and pipeline assets 🦠 Legend Biotech announced that the European Commission has granted approval of CARVYKTI® for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, have demonstrated disease progression on the last therapy and are refractory to lenalidomide. 🦠 Vertex Pharmaceuticals and TreeFrog Therapeutics announced that Vertex has obtained an exclusive license to TreeFrog's proprietary cell manufacturing technology, C-StemTM, to optimize production of Vertex's cell therapies for type 1 diabetes (T1D). C-Stem™, is designed to mimic the natural microenvironment, allowing cells to grow exponentially in 3D. The technology will enhance Vertex's ability to generate large amounts of fully differentiated cells for its portfolio of T1D cell therapies 🦠 TScan Therapeutics announced closing of upsized public offering. The gross proceeds to TScan from this offering were approximately $150.1 million, prior to any exercise of the underwriters’ option to purchase additional shares of voting common stock and before deducting underwriting discounts and commissions and other estimated offering expenses payable by TScan. The company intends to use the net proceeds from the offering for general corporate purposes. TScan expects its existing cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026. 🦠 SCG Cell Therapy and the A*STAR - Agency for Science, Technology and Research in Singapore launched joint laboratories to advance the development of iPSC technology to produce novel cell therapies that meet GMP standards. The collaboration is supported by $22 million under Singapore’s Research, Innovation and Enterprise 2025 Plan. The joint laboratories leverage SCG’s and A*STAR’s proprietary technologies to develop scalable GMP-grade iPSC and therapeutic products

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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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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/3XbiLVq

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Did you know? BIB can build out a custom facility for you with our patented, revolutionary PanFlex engineering! Unlike conventional methods, PanFlex-Engineering adopts a bottom-up approach, building facilities based on clients' needs, increasing usage, and reducing costs. Learn more about our groundbreaking collaboration with 89bio to manufacture pegozafermin, addressing unmet medical needs in metabolic dysfunction-associated steatohepatitis (MASH). Our partnership exemplifies innovation, efficiency, and transformative business in the biotech industry. About: Boston Institute of Biotechnology, LLC (BIB) has recently entered into a groundbreaking collaboration agreement with 89bio (NASDAQ: ETNB) to construct a state-of-the-art production facility for the manufacturing of pegozafermin, a potential treatment for metabolic dysfunction-associated steatohepatitis (MASH). Under the terms of the agreement, BIB's sister company, BiBo Biopharma Engineering, will spearhead the construction of the production facility. This facility will be specifically designed to supply 89bio with pegozafermin for commercialization, pending approval. Key Achievements and Impact: The collaboration represents a transformative business partnership between BIB and 89bio, aiming to address the unmet medical needs of patients suffering from MASH. By leveraging BIB's extensive experience in contract manufacturing and engineering expertise, the deal enables the establishment of a cutting-edge production facility dedicated to pegozafermin. The construction of the facility aligns with 89bio's strategic vision to secure manufacturing capacity to meet commercial demand for pegozafermin, based on promising mid-stage study results. Summary: This transformative partnership not only showcases BIB's expertise in CMC services but also highlights its pivotal role in advancing innovative therapies for complex diseases. https://lnkd.in/eA62cPqd #Biotech #Innovation #PanFlex #Collaboration #BIB #89bio

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Sartorius and Sanofi Collaborate to Boost Downstream Process Efficiency Life science group Sartorius and #biopharmaceutical firm Sanofi are partnering to create a platform for continuous downstream #bioprocessing. Sartorius will use its engineering and manufacturing skills to commercialize integrated and continuous #biomanufacturing (ICB) platforms, using Sanofi’s prototypes. In exchange, Sanofi will provide Sartorius with exclusive access to its ICB #platform knowledge and patents. Integrated continuous biomanufacturing (ICB) is a modern method for biopharmaceutical production. It aims for efficiency through continuous flow and integration of operations, contrasting traditional batch methods. ICB minimizes process footprint, leading to reduced resource use and waste, and increased productivity. Read more on #CMI online: https://lnkd.in/ehndQZJ9

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Click below to learn more about the exciting growth at Jubilant HollisterStier and how it further bolsters pharmaceutical manufacturing right here in North America. #contractmanufacturing #pharmaceuticalmanufacturing #JubilantHollisterStier #biomanufacturing #manufacturing #sterilefillfinish #biotech #biologics #fillfinish

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Clinical Updates: #BIOSECURE Act gives drug makers until 2032 to sever ties with China. What does this mean for US Pharma? The BIOSECURE Act is a bill in the US Congress aimed at reducing reliance on Chinese biotechnology companies. It prohibits US government agencies and drug manufacturers from working with these firms, which are considered a national security risk. The latest version of the Act includes a grace period until 2032 for drugmakers to find alternative suppliers, acknowledging the challenges of an immediate switch. This could still disrupt existing supply chains and potentially lead to drug shortages or delays in research. What are tyhe possible effects? Here there is a brief summary of what this could mean for the US pharma industry: Disrupted Supply Chains: Many US drug companies rely on Chinese firms like WuXi AppTec for services like manufacturing or clinical trials. Finding new suppliers and building new partnerships will take time and resources, potentially causing delays in drug development and production. Drug Shortages: The transition period may not be smooth, leading to temporary shortages of existing medications that rely on Chinese suppliers. Increased Costs: Finding new suppliers or building in-house capabilities may be more expensive than using established Chinese firms. This could drive up drug development costs and potentially impact drug prices for consumers. Research Delays: Disruptions in ongoing research partnerships with Chinese companies could set back development timelines for new drugs and therapies. Innovation Impact: The US may lose access to some of the expertise and technologies offered by Chinese firms, potentially hindering advancements in the pharmaceutical and biotechnology sectors. https://lnkd.in/e3gvjsUd #medicalaffairs #clinicaldevelopment #medicaljobs #clinicaljobs

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📢 Entos Pharmaceuticals Opens State-of-the-Art GMP Facility 📢 Entos Pharmaceuticals has opened a GMP facility in Carlsbad, CA to support IND-enabling studies and clinical trials. 🔬 The facility is 20,000 square feet and will help Entos advance its pipeline of 20 programs. 💰 The cost of the facility has not been disclosed, but it has room for expansion. 🌎 Entos also plans to build a commercial manufacturing facility in Alberta, Canada, as part of its global manufacturing strategy. #BioprocessUpdates #EntosPharmaceuticals #GMPfacility #manufacturing #clinicaltrials #INDenablingstudies #pharmaceuticalindustry #CarlsbadCA #pipeline #expansion #globalmanufacturing #AlbertaCanada #commercialmanufacturing #biotech #pharmaceuticals #medicalresearch ▷ Read the full article here: 📎 https://lnkd.in/dE4eRN7n

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