Rebecca Lyth

💊 CDMO Power Move: Thermo Fisher Scientific Adds Another Site to the Collection 💊 Thermo Fisher has just completed the acquisition of Sanofi’s sterile fill-finish & packaging site in Ridgefield, New Jersey. 🏭 Here’s the play-by-play: ⚡ Another big pharma site makes its way into CDMO hands. 👥 200+ talented people join the Thermo Fisher network overnight. 📦 Ridgefield will keep cranking out Sanofi therapies and open capacity for other pharma & biotech players. 🇺🇸 Adds to Thermo’s growing U.S. sterile drug product footprint (Greenville, NC + Plainville, MA). Marc Casper, CEO of Thermo Fisher, called the facility “world-class” – and to be fair, he’s not wrong. From a talent angle, it’s another reminder that fill-finish & packaging skills are hot property right now. Integration = opportunity, whether you’re in QA, regulatory, ops, or site leadership. 👉 Question for you: will we see more big pharma offloading sites to the CDMO giants… or are we reaching peak consolidation? #CDMO #Biologics #Pharma #Recruitment #ThermoFisher

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🚨 Big Moves in Biologics Manufacturing! 🚨 💉 Simtra BioPharma Solutions is stepping up in a major way with a bold expansion in Bloomington, Indiana, aiming to become the first CDMO to offer commercial-scale drug product manufacturing of antibody-drug conjugates (ADCs) in the U.S. 🏗️ The company has acquired a 65-acre property with 300,000+ sq ft of usable space to expand its injectable biologics capabilities. While details are still under wraps, this new facility will focus on oncology injectables and feature isolator-based vial and prefilled syringe lines. 📈 This move builds on Simtra’s ongoing $250M expansion at the same site (announced Feb 2024), which includes: ✅ A new 150,000 sq ft building ✅ 2 high-speed isolator fill lines ✅ A new freeze-drying line with three 30-sq-meter lyophilizers 🌍 Simtra is also scaling globally: 💶 $100M production site completed in Halle, Germany 🇩🇪 💵 $14M conjugation & purification suite underway in Germany 🤝 ADC production is heating up: 💥 Simtra + MilliporeSigma (Merck KGaA) → a 5-year partnership to offer “turnkey ADC manufacturing” across U.S. facilities 💥 CARBOGEN AMCIS → investing $31M with a Japanese partner for ADC linker production in Switzerland 🇨🇭 💥 Veranova → pouring in $20M at its Massachusetts site to boost bioconjugation capacity 💊 📣 "This purchase gives us the foundation to grow with purpose, building the advanced injectable capacity our customers need while strengthening our presence in North America," said Franco Negron, Chief Executive Officer, Simtra BioPharma Solutions. "It reflects our long-term commitment to delivering vital injectable products and helping our customers navigate complex global supply chains."

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🚨 Another Big move in the biologics CDMO space 🚨 Sandoz plans to acquire Just - Evotec Biologics Biologics EU (Toulouse site) for $300M. 🔹 Evotec is shifting to an asset-light, tech-first model, licensing out its continuous manufacturing platform. 🔹 Sandoz gets full control of a purpose-built biologics site, expanding its biosimilar capabilities. 🔹 This deal signals where the market’s headed: efficiency, scalability, and tech-led partnerships. Is this the start of a new playbook? IP-driven growth > bricks and mortar. #CDMO #Biologics #Sandoz #Evotec #Biosimilars #Biomanufacturing #Outsourcing #PharmaStrategy #BD #Growth #Biopharma

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👨‍🔬💬 𝐂𝐞𝐥𝐥 & 𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐢𝐭𝐲: 𝟐𝟔𝐭𝐡 𝐒𝐞𝐩𝐭𝐞𝐦𝐛𝐞𝐫 𝟐𝟎𝟐𝟓 👩‍🔬💬 🧬 uniQure announced positive topline results from its pivotal Phase I/II study of AMT-130, a gene therapy for Huntington’s disease. High-dose AMT-130 significantly slowed disease progression over 36 months, meeting the primary endpoint and a key secondary endpoint compared to an external control. Favorable trends were observed across cognitive and motor measures, with reduced CSF NfL levels suggesting decreased neurodegeneration. 🧬 Sanofi’s SAR446268, a one-time AAV gene therapy for non-congenital myotonic dystrophy type 1 (DM1), has received FDA Fast Track designation to accelerate its development and review. The therapy uses RNA interference to silence DMPK expression, aiming to remove toxic RNA foci, restore normal splicing, and improve muscle function. It targets key DM1 symptoms, including progressive muscle weakness and myotonia, and addresses systemic effects on heart, lungs, and endocrine function. 🧬 Cure Rare Disease announced that the FDA has granted Orphan Drug Designation for its gene therapy CRD-003 to treat Limb-Girdle Muscular Dystrophy Type R9 (LGMD2i/R9), which currently has no approved treatments. CRD-003 uses an AAV vector to deliver FKRP under a muscle-specific promoter, restoring alpha-dystroglycan glycosylation to maintain muscle integrity. The therapy targets progressive skeletal, cardiac, and CNS muscle weakness caused by FKRP mutations. 🦠 Aspen Neuroscience, Inc. initiated Cohort 3 of its ASPIRO Phase 1/2a trial for ANPD001, a personalized autologous dopaminergic neuronal precursor cell therapy for moderate-to-advanced Parkinson’s disease. This cohort uses Aspen’s commercial formulation, enabling scalable, cryopreserved dosing without immunosuppression. ANPD001 is derived from patient skin cells, reprogrammed into iPSCs and differentiated into dopaminergic cells, delivered via a precision MRI-guided system. 🧬 Intellia Therapeutics, Inc. reported positive longer-term Phase 1 data for nexiguran ziclumeran (nex-z) in hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN). A one-time dose achieved deep, durable TTR reductions across patients, including those who had progressed on patisiran. Most patients showed stability or clinically meaningful improvements in neuropathy scores, quality of life, and disability measures. 🦠 Hemostemix Inc. (TSXV: HEM | OTCQB: HMTXF | FSE: 2VF0) has filed FDA Pre-IND 1517 to advance ACP-01 (VesCell™), its autologous stem cell therapy, via a basket Phase I trial across multiple ischemic and vascular conditions. The basket protocol aims to evaluate safety, feasibility, and early efficacy across indications under a unified design, accelerating development and expanding therapeutic potential. 🛎 My aim is to be the messenger when it comes to your CGT news. Follow #mCGT to stay updated! #celltherapy #genetherapy #ATMP #advancedtherapy

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☀️ Happy Friday Network ☀️ 🔬 CDMO Highlights Across Europe Symbiosis Pharmaceutical Services hits its 1,000th sterile injectable batch — a major GMP milestone Honoured with the King’s Award for Enterprise, spotlighting global biotech impact UK CDMOs are driving innovation in ATMPs, radiopharmaceuticals, and personalised medicines 🇮🇪 Ireland PCI Pharma Services expands sterile capacity for lyophilised biologics and high-potency injectables CDMOs investing in digital batch records and real-time analytics to boost biotech agility 🇨🇭 Switzerland ten23 health leads in complex sterile biologics and sustainable manufacturing 🇩🇰 Denmark AGC Biologics doubles mammalian capacity — now delivering up to 200 GMP batches/year FUJIFILM Biotechnologies Denmark expands digital manufacturing and builds strategic partnerships 🚀 Biotech & Pharma Headlines Padcev + Keytruda combo approved for NHS use in metastatic urothelial carcinoma AbbVie seeks Rinvoq approval for alopecia, outperforming Olumiant in Phase III ADVANZ PHARMA & Alvotech receive EU approval for Mynzepli, biosimilar to Eylea Jazz Pharmaceuticals signs global licensing deal with Saniona for SAN2355, a novel epilepsy candidate 🔍 Roles & Opportunities Switzerland: Advanced QA experts, QC Analysts Denmark: QA roles, French speaker: QC Chemist, QC Analyst UK: Deputy RP, Operational QA What’s the most exciting CDMO trend you’re seeing in your region right now? Let’s share insights and celebrate progress across the network? Wishing everyone a lovely weekend and a relaxing Bank Holiday #Pharma #Biotech #CDMO #SterileManufacturing #Oncology #FridayNetwork Proclinical Staffing

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🚀 Big pharma money is on the move and small biotechs should be paying attention 🚀 Sanofi Ventures just raised $625M to fuel innovation in rare disease, neurology, immunology, and vaccines. For early-stage biotechs, this could mean survival and speed in a tough funding climate. It also means small companies will need sharper market access and pricing strategies earlier than ever. 👉 Will pharma VCs reshape the biotech funding landscape in 2026?

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