Ritedose expands lab capacity with $17M investment

We provide a full range of laboratory services, including Preformulation Screening, Analytical/Stability, Analytical Development and Quality Control, and CMC Package Services. In 2025, we launched a state-of-the-art laboratory dedicated to highly potent parenteral products (up to OEB 5). Our team of experienced specialists, including PhD-level scientists, conducts over 4,000 different tests, covering both APIs and finished dosage forms (FDF). 🔬 With advanced instrumentation such as electron microscopy, X-ray diffraction, ICP-MS, and Raman spectroscopy, we uncover hidden structures, guide polymorph identification, and perform particle size and morphology analyses to ensure a precise understanding of critical product attributes. 🧪 Stability testing is one of the key pillars of our expertise. In ICH-compliant chambers across all climatic zones, we conduct long-term, accelerated, and in-use studies, delivering robust data that support regulatory submissions and enable the safe market introduction of new medicines. 💊 #TZFPolfa #pharmaceuticals #pharma #analyticalservices #pharmaceuticalanalysis #laboratorytesting #CDMO

What’s your plan when an unknown material halts your production? In pharmaceutical manufacturing, unidentified fibres or residues can trigger costly investigations and stall batch release. Fourier transform infrared spectroscopy (FTIR) gives you a fast, reliable way to identify unknowns expediently and on-site. By matching spectral signatures to known references, the technique speeds up root cause analysis and supports quality investigations within pharma, in line with global regulatory standards. The team at Amgen identified contaminants in a fill/finish facility using FTIR, pinpointing the source and restoring production quickly. Tools like the Quest™ and Pearl™ make this rapid response practical for every QC lab. Explore more real-world FTIR applications in pharma: https://lnkd.in/eEXX2JHS #ContaminationDetection #PharmaQC #Specac

For pharmaceutical products facing particulate contamination risks or seeking enhanced analytical precision, subvisible particle analysis offers a scientifically robust pathway that can accelerate method validation and expand quality assurance capabilities. This evidence-based approach will be explored in depth during "Subvisible Particle Analysis: Ensuring Quality from Lab Bench to GMP", where Dr. Bodo Brocks, Quality Unit Manager and Dr. Sergey Sotnikov, Principal Scientist GMP from Coriolis Pharma will focus on transforming analytical methods into validated quality control systems. 📅 November 18, 2025  ⏰ 16:00 CET | 10:00 ET 🔗 Register here: https://lnkd.in/eMRawVf5 How could enhanced particle analysis revolutionise your current quality control approach? #CoriolisPharma #PharmaDmand #AnalyticalDevelopment #RegulatoryCompliance #MethodValidation 

📄 Container Closure Integrity (CCI): A critical factor in sterility assurance Sterility assurance remains one of the most frequently cited issues in drug recalls. With the revised EU GMP Annex 1 and continued FDA emphasis on CCI, the expectations for parenteral product developers and CDMOs have never been higher. However, challenges including increasingly complex modalities (mRNA, lipid nanoparticles), cold-chain storage requirements, material variability, and evolving regulatory demands make CCI more difficult to achieve. 📄 Discover a holistic, data-driven, and risk-based approach to CCI that extends beyond release and stability testing. Topics include: ✔️ Deterministic CCI testing methods (e.g., helium leak detection) and why regulators favor them ✔️ Proprietary Lonza technologies for extreme-condition testing (down to -80°C) ✔️ How upfront platform data can minimize drug substance use, accelerate timelines, and reduce regulatory risk ✔️ A lifecycle-spanning framework covering system development, material qualification, manufacturing, and distribution By integrating these strategies early, you can safeguard product quality, mitigate risks, and accelerate clinical and commercial success. 👉 Download a risk-based approach to CCI can strengthen your development program: https://lnkd.in/e5FSEuTs This whitepaper is in association with Lonza.

In this Guide to Outsourcing, Doug Botkin, PhD, of Charles River Laboratories, discusses how modern microbial ID tools enhance contamination control and the benefits of outsourcing. Inside, you’ll find out how microbial ID technologies supported by pharmaceutical expertise can help: -Strengthen your contamination control strategy -Meet regulatory standards -Quickly resolve microbial excursions -Build confidence in EMPQs and water qualifications Learn more: https://okt.to/O1WtfM  #Accugenix #MicrobialID #Straintyping #EMPQ #WaterSystemQualification

𝐓𝐡𝐢𝐧 𝐋𝐚𝐲𝐞𝐫 𝐂𝐡𝐫𝐨𝐦𝐚𝐭𝐨𝐠𝐫𝐚𝐩𝐡𝐲 (𝐓𝐋𝐂) is no longer just a classic technique—it's a powerhouse of modern pharmaceutical innovation. From High-Performance TLC (HP-TLC) to hyphenated methods like TLC-SERS and TLC-MS, advancements are revolutionizing impurity profiling, chiral separations, and real-time reaction monitoring. In our latest article, Senior Scientist Poonam D. of TCG GreenChem Inc. explores how these innovations enhance efficiency and accuracy in drug development and quality control. 𝐊𝐞𝐲 𝐡𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 𝐢𝐧𝐜𝐥𝐮𝐝𝐞: ➡️ The rising role of HP-TLC as a cost-effective, high-throughput alternative to HPLC. ➡️ Breakthroughs in chiral separations are critical for enantiomer-specific drug efficacy and safety. ➡️ The power of automation and hyphenated techniques for unparalleled analytical precision. Position your R&D and QC labs at the forefront of pharmaceutical analysis. 𝐑𝐞𝐚𝐝 𝐭𝐡𝐞 𝐟𝐮𝐥𝐥 𝐚𝐫𝐭𝐢𝐜𝐥𝐞 𝐭𝐨 𝐝𝐞𝐥𝐯𝐞 𝐢𝐧𝐭𝐨 𝐭𝐡𝐞 𝐭𝐞𝐜𝐡𝐧𝐢𝐜𝐚𝐥 𝐝𝐞𝐭𝐚𝐢𝐥𝐬 𝐚𝐧𝐝 𝐚𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬. https://lnkd.in/gAnEkWud 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐭𝐡𝐞 𝐥𝐚𝐭𝐞𝐬𝐭 𝐦𝐚𝐠𝐚𝐳𝐢𝐧𝐞 𝐢𝐬𝐬𝐮𝐞 𝟔𝟎:  https://lnkd.in/gAAbc_e #PharmaceuticalAnalysis #TLC #HPTLC #DrugDiscovery #QualityControl #ChiralSeparations #PharmaR&D #AnalyticalChemistry #PrecisionMedicine #PharmaTech #Innovation #RegulatoryScience #SERS #MassSpectrometry #ThoughtLeadership

In this Guide to Outsourcing, Doug Botkin, PhD, of Charles River Laboratories, discusses how modern microbial ID tools enhance contamination control and the benefits of outsourcing. Inside, you’ll find out how microbial ID technologies supported by pharmaceutical expertise can help: -Strengthen your contamination control strategy -Meet regulatory standards -Quickly resolve microbial excursions -Build confidence in EMPQs and water qualifications Learn more: https://okt.to/O1WtfM #Accugenix #MicrobialID #Straintyping #EMPQ #WaterSystemQualification

BioPhorum Quality is pleased to see the arrival of the new paper 'Navigating Annex 1: Industry insights and regulatory clarity' from our colleagues in BioPhorum Fill Finish, bringing together two important resources: - Annex 1 implementation survey: Offering a snapshot of how companies are responding to regulatory expectations - Annex 1 FAQs: A practical guide for global compliance addressing address scope, applicability and global interpretation of Annex 1 You can download your copy here: https://lnkd.in/eacE3MXg Quarterly joint Phorum sessions aim to connect Annex 1 workstreams from within BioPhorum Quality, BioPhorum Drug Substance and BioPhorum Fill Finish, to share awareness of industry hot topics, discuss general inspection challenges and table questions for peer-to-peer insights. If you're interested in learning more about our Annex 1 workstreams, and how your organization can get involved, contact us at hello@biophorum.com.

The ISPE Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (3rd Edition) brings updated tools and insights for evaluating airborne particle emissions from pharmaceutical containment systems. Building on the foundations of earlier editions, this guide continues to offer practical, hygiene-focused methods for testing airborne emissions and surface contamination using surrogate materials under controlled conditions. What’s new in this edition? Expanded guidance for evaluating complex setups like continuous manufacturing, improved strategies for surrogate selection, and enhanced techniques for analyzing and interpreting data. Whether you're designing, validating, or maintaining containment systems, this guide provides the standardized approach you need to ensure safety and performance. Explore the latest edition: https://lnkd.in/eqC_7SvV

Tired of OOS Results Derailing Your Dissolution Testing? 🧪 Dissolution analysis is crucial for drug development, but unreliable results (OOS) often trace back to one major culprit: dissolved gases and inconsistent media preparation. This variability compromises your data integrity and workflow efficiency. Introducing the RT510 Automated Media Preparation System – your solution for rock-solid stability and reproducibility! ✨ Key Features: ✅ Automatic Degassing: Effectively eliminates dissolved gases, a primary cause of OOS results. ✅ Precise Media Dispensing: Ensures accurate and consistent media volume and distribution. ✅All-in-One Efficiency: Combines pre-treatment and dispensing into one seamless, automated process. Minimize risk, maximize precision, and keep your dissolution testing on track. Invest in the quality and reliability your lab deserves. ➡️ Learn how the RT510 can transform your lab's workflow and data stability. https://lnkd.in/g8g3Q3ZQ #Pharmaceuticals #DissolutionTesting #LabAutomation #QualityControl #RT510 #DataIntegrity