James Christie

Almac Group’s new GMP-qualified analytical stability chambers have officially opened at our Souderton, PA site! This $2 million investment builds on the multi-million-dollar expansion of global analytical services and reinforces Almac’s commitment to meeting growing client demand. Read more: https://hubs.li/Q03zWzQJ0 #cdmo #analyticaltesting #stabilitytesting #expansion

101

7 Comments

Pass Your First GMP Audit in QC Nail the basics. Show control. Prove data integrity. 🚀 Your 7-step playbook Prep: Current SOPs, training matrix, clear RACI. Records: ALCOA+ docs, real-time entries, version control. Methods & Equipment: Validations, IQ/OQ/PQ, calibration logs, standards traceability. Data Integrity: Audit trails, access control, backups, e-signatures, change control. Training & CAPA: Role-based refreshers, tight CAPA timelines. Mock Audit: Risk-based self-inspection, doc room, SME brief, evidence index. Audit Day: One voice, fast retrieval, clean narratives, calm execution. CTA — Get audit-ready now 📚 Build your GMP skills HERE: https://lnkd.in/dK5xJRd2

72

"Successfully delivering high-concentration biologics in a PFS (prefilled syringe) requires more than a stable formulation. It demands a cross-functional approach in which formulation development, device characterization, and process design are addressed holistically." Lonza experts David Schmitt, Flora Felsovalyi, Orla McGarvey and Michael Jahn discussed the growing importance of PFS in The Medicine Maker, focusing on the challenges involved in developing stable formulations for high-concentration biologics. Read the full article here: https://lnkd.in/dChttAsP

73

𝐒𝐮𝐜𝐜𝐞𝐬𝐬𝐟𝐮𝐥 𝐅𝐃𝐀 𝐏𝐀𝐈 𝐈𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧 Pharmaron is pleased to share that our Shaoxing, China site has successfully completed an FDA cGMP on-site pre-approval inspection (PAI) in June 2025 that included all relevant GMP systems.  The Establishment Inspection Report confirms that Pharmaron is in compliance with all cGMPs. Shaoxing is Pharmaron’s largest commercial manufacturing site with capabilities to produce API, GMP intermediates and regulatory starting materials (RSM), complemented by utilizing flow chemistry, biocatalysis, photochemistry and other emerging technologies. To learn more about Pharmaron’s manufacturing capabilities, contact us today.

155

2 Comments

📢 Seamless lab-to-production integration is a key step toward truly digital manufacturing. We’re excited to share that SOTAX q-doc® is now officially PAS-X MSI Plug & Produce ready. As a leading provider of pharmaceutical testing systems, SOTAX Group supports global pharma companies with innovative solutions in dissolution testing, automated sample preparation and physical testing. This certification enables secure bi-directional data exchange between the IPC laboratory and our PAS-X MES, ensuring: ✔️ centralized test result capture ✔️ improved data integrity ✔️ faster, more compliant batch release A strong step forward in connecting quality control and manufacturing. 🔗 Read more here: https://lnkd.in/ezYEV-uf

94

#CaseStudy • Eurofins E&E UK 🏴󠁧󠁢󠁳󠁣󠁴󠁿 When the Eurofins E&E UK team in Scotland needed an advanced EMC test facility to enhance their existing industry-leading testing capabilities, they trusted ETS-Lindgren to design and build a flexible test chamber system — one that serves a wide range of applications including aerospace, automotive and general EMC testing! 👉 Read the full Case Study: https://bit.ly/45gwH49 ETS-Lindgren | Committed to a smarter, more connected future. #emc #rfshielding #anechoicchamber

26

3 Comments

🔬 𝗨𝗦𝗣 𝟰 𝗶𝗻 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵: 𝗨𝗻𝗹𝗼𝗰𝗸𝗶𝗻𝗴 𝗗𝗶𝘀𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 From innovative release studies to advanced formulation development, the USP 4 flow-through cell method (Apparatus 4) continues to prove its value in pharmaceutical research. Its ability to simulate dynamic in vivo conditions makes it especially powerful for investigating complex dosage forms. At the core of this approach, the CE 7smart dissolution tester empowers researchers to go beyond routine QC—delivering meaningful insights into drug release, bioavailability, and formulation performance. 📄 We’ve just released an updated white paper featuring nearly 100 scientific publications using the CE 7smart system. 𝙁𝙞𝙡𝙩𝙚𝙧 𝙗𝙮 𝙙𝙤𝙨𝙖𝙜𝙚 𝙛𝙤𝙧𝙢 𝙖𝙣𝙙 𝙚𝙭𝙥𝙡𝙤𝙧𝙚 𝙝𝙤𝙬 𝙐𝙎𝙋 4 𝙞𝙨 𝙨𝙝𝙖𝙥𝙞𝙣𝙜 𝙩𝙝𝙚 𝙛𝙪𝙩𝙪𝙧𝙚 𝙤𝙛 𝙙𝙞𝙨𝙨𝙤𝙡𝙪𝙩𝙞𝙤𝙣 𝙩𝙚𝙨𝙩𝙞𝙣𝙜 👉 https://lnkd.in/d4fYx6NT #SOTAX #DissolutionTesting #USP4 #PharmaResearch #CE7smart #InnovationInScience

69

1 Comment