Ameer Khan

🚀 New Partnership Alert Arkivum has teamed up with PHARMASEAL to deliver a complete end-to-end clinical trial technology solution. By combining Arkivum’s GxP-validated digital archiving with PHARMASEAL’s Engility CTMS & eTMF, sponsors can now: ✅ Build data-retention planning in from day one ✅ Ensure long-term integrity, accessibility & inspection readiness ✅ Stay fully compliant with ICH E6 (R3), EU CTR, and evolving regulations “This partnership will increase awareness of the importance of a fit-for-purpose solution to preserve all essential clinical trial records and data,” said Chris Sigley, CEO of Arkivum. Ricky Lakhani, Chief Product Officer at PHARMASEAL, added, “It guarantees that critical trial records remain accessible, compliant, and usable for decades to come.” This collaboration future-proofs clinical trial records, keeping essential data secure and usable for decades. #ClinicalTrials #LifeScienceNews #BioPharma #CRO

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Upperton Pharma Solutions and University of Oxford partner on oral vaccine development! Upperton Pharma Solutions has secured funding from the Vaxhub sustainable platform funding call to develop an oral formulation for Adenovirus-vectored vaccines. Professor Dame Sarah Gilbert and her team at Oxfords Pandemic Sciences Institute will focus on stability with Upperton Pharma Solutions contributing their expertise in OSD Development, Particle Engineering and Spray drying. Richard Johnson, Founder and CSO, noted "We’re proud to partner with the University of Oxford on this initiative: Oral vaccine delivery has the potential to transform global immunisation and pandemic response strategies, and this project is a significant step forward where we can apply our formulation development expertise.” The project is due to be completed in July 2026, exciting times ahead.... #CDMO #CRO #OSD #Oxford

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👨‍🔬💬 𝐂𝐞𝐥𝐥 & 𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐢𝐭𝐲: 𝟐𝟐𝐧𝐝 𝐉𝐮𝐥𝐲 𝟐𝟎𝟐𝟓 👩‍🔬💬 🧬 AAVantgarde received FDA clearance to begin a Phase 1/2 clinical trial for AAVB-039, its gene therapy candidate for Stargardt disease, a common inherited form of macular degeneration. The therapy uses AAVantgarde’s dual AAV intein platform to deliver the large ABCA4 gene, aiming to address the genetic root cause of the condition. This is their second program to enter the clinic, alongside AAVB-081 for Usher syndrome type 1B. 🧬 Genascence Corporation received RMAT designation for GNSC-001, its gene therapy candidate for knee osteoarthritis (OA). GNSC-001 uses an AAV vector to express IL-1Ra, a protein that blocks IL-1, a key driver of inflammation and cartilage damage in OA. Designed for long-term efficacy via a single joint injection, GNSC-001 has shown sustained therapeutic IL-1Ra levels in early trials. 🧬 Rocket Pharmaceuticals received RMAT designation for RP-A601, its investigational gene therapy for PKP2-arrhythmogenic cardiomyopathy (PKP2-ACM), a life-threatening genetic heart disease. RP-A601 uses an AAVrh74 vector to deliver a functional PKP2 gene via a one-time IV infusion. Early Phase 1 data show strong safety, increased PKP2 expression, improved heart structure, and better clinical outcomes. 🦠 CytoMed Therapeutics Limited successfully completed dose level 1 of its first-in-human Phase I ANGELICA trial for CTM-N2D, an allogeneic CAR gamma delta T cell therapy targeting NKG2DL, and will advance to dose level 2 in Q3 2025. CTM-N2D is derived from healthy donors and modified to target cancer-associated antigens found in both solid tumors and blood cancers. Unlike conventional autologous CAR-T therapies, CTM-N2D does not require patient-donor matching. 🧬 NKGen Biotech, Inc. received FDA authorization for an Expanded Access Program (EAP) allowing the use of its investigational autologous NK cell therapy, troculeucel, in up to 20 patients with various neurodegenerative diseases. While troculeucel is currently in a Phase 2a trial for moderate-stage Alzheimer’s disease, the EAP extends access to earlier-stage Alzheimer’s and other conditions including Parkinson’s, ALS, MSA, PSP, FTD, CBD, MS, and LBD. 🧬 Sanofi’s gene therapy candidate SAR446597 has received FDA Fast Track designation for geographic atrophy caused by age-related macular degeneration (AMD). SAR446597 is a one-time intravitreal gene therapy delivering antibody fragments that inhibit two key components of the complement pathway (C1s and factor Bb) aiming to reduce inflammation and retinal damage. This dual-targeting strategy may offer sustained therapeutic effects and reduce the need for repeated injections. 🛎 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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