Solvias

Our insightful session on advanced Extractables and Leachables (E&L) screening is now available on demand. Led by Ulli Hohenester, Team Leader for E&L and HRAM Trace Analysis at Solvias, this webinar explores the use of High-Resolution Mass Spectrometry (HRAM-MS) combined with liquid and gas chromatography (LC, GC). Discover how these techniques are transforming E&L analysis, enabling more precise identification at lower analytical thresholds. 🔗 Watch now: https://lnkd.in/e9WeiPpX #extractables #leachables #E&L #HRAM #webinar

Cell-based bioassays (CBBAs) are essential for the development of advanced therapies, but their complexity and variability require careful navigation. We now have two valuable resources to support your success: 📄 White Paper: "The Potency Puzzle: Overcoming Challenges in Potency Assays for Cell and Gene Therapy Development" https://lnkd.in/eif74Kir 🎥 Webinar Recording: "Navigating Complexity: Tailoring Cell Based Bioassays for Advanced Therapeutics" https://lnkd.in/eraRFxJv Access both resources now and learn how to overcome CBBAs challenges. #CBBA #cellbasedbioassays #bioassays #PotencyAssays #CellAndGeneTherapy #Biologics

It's important to have a lab that supports the entire life cycle of cell & gene therapy CMC analytical development. This allows for molecule and method specific knowledge to be easily transferred from characterization, through method development, validation, and ultimately GMP commercial release testing. #CGT #AAV #celltherapy #genetherapy #CMC #GMP #analyticaldevelopment

As we celebrate Solvias' 25th anniversary, we've curated 25 facts that showcase our journey, milestones, and what sets us apart as a trusted partner to the world's leading pharmaceutical companies. Swipe through to explore our story! A heartfelt thank you to our clients, partners, and the amazing Solvias team for making these 25 years a success. #solvias25 #cmc #cro #cdmo

Biologics and cell & gene therapies are the fastest-growing areas in the pharmaceutical industry. These complex molecules are produced in living cells through multistep processes, making precise analytical methods essential for quality control and regulatory approval. A broad range of methods is required to ensure identity, purity, potency, safety, and immunochemical properties. Among these, three stand out for their high flexibility and versatility: Capillary Electrophoresis (CE), Enzyme-Linked Immunosorbent Assay (ELISA), and Surface Plasmon Resonance (SPR). ✔️ ELISA: A highly sensitive method for detecting and quantifying process-related impurities, such as host cell proteins (HCP), which is critical for ensuring product safety during release analysis. ELISA is the gold standard method for measuring protein affinity to its target, and is commonly used in potency assays for both release and stability testing. ✔️ CE: A high-resolution separation technique for the analysis of a wide variety of biomolecules, from amino acids to viral particles. Providing great separation efficiency, CE surpasses other conventional techniques such as LC in many aspects. CE methods available at Solvias include CGE (UV, LIF), CGE-SDS (UV, LIF), cIEF (UV, FL, MS), and CZE (UV, LIF, MS). These methods assess product quality by analyzing isoforms, impurities, as well as size and charge heterogeneity. ✔️ SPR: Our SPR services offers comprehensive, real-time, label-free analysis that preserves the natural state of molecules and provides immediate insights into binding interactions. These services include affinity measurement (KD), on- and off-rate determination (kon and koff), potency assessment (EC50), batch-to-batch comparability, and stability testing. ✉️ Reach out to us at info@solvias.com to discover how these methods can advance your biologics and cell & gene therapies development.

It’s 6:02 a.m., and we’re already posting on LinkedIn. Too early? Not today! That’s because today is Mole Day, celebrated on October 23 from 6:02 a.m. to 6:02 p.m., in honor of Avogadro's Number (6.02 x 10²³). One mole of a substance contains Avogadro's number of elementary entities. For example, 1 mole of copper contains 6.02214076 x 10²³ atoms of Cu and weighs 63.546 grams Happy Mole Day to all the scientists and chemistry enthusiasts! #moleday #chemists #avogadro

Pyrogen testing is essential for the safety of parenteral products and medical devices, preventing life-threatening fever reactions induced by pyrogenic substances. The Monocyte Activation Test (MAT) is a step forward in ensuring patient safety, regulatory compliance, and ethical testing practices: 🐰Unlike the Rabbit Pyrogen Test (RPT), MAT is an animal-free testing method ✔️MAT detects both endotoxin and non-endotoxin pyrogens 🎯 MAT has a lower limit of detection compared with the Rabbit Pyrogen Test (RPT) 💉MAT is suitable for a range of drug products, especially parenteral drugs and biologics Interested in learning more about how MAT can benefit your products? Contact us at info@solvias.com.

Wrapping up our interview series from Research Triangle Park (RTP), we're proud to feature Anamica Sriram Muruganandham, our Director of Molecular Biology Services. Anamica highlights how our advanced integrated LIMS (Laboratory Information Management System) and ELN (Electronic Lab Notebook) streamline laboratory operations, improve data management, and elevate the overall quality of our services. 📽️ Watch Anamica's insights in the full interview below! 👇

Last month, the FDA released a new guidance on the “Control of Nitrosamine Impurities in Human Drugs”, updating their 2021 recommendations. The guidance covers: 🔬 Root Causes of Nitrosamine Formation – including small molecule nitrosamines and nitrosamine drug substance-related impurities (NDSRIs) 📊 Control & Mitigation Recommendations – for both APIs and drug products ✔️ Acceptable Intake Limits – with guidance on testing, risk assessment timelines, and necessary regulatory submissions Ready to stay ahead of evolving regulations? Solvias provides rapid nitrosamine screening and development/validation of control methods for small nitrosamines, NDSRIs, and any other genotoxic impurities with unparalleled sensitivity and selectivity. We utilize well-established GC/MS/MS and LC/MS/MS methods which showcase exceptional accuracy, consistently delivering outstanding performance within the low parts-per-billion thresholds mandated by regulatory authorities. Contact us at info@solvias.com to learn more

What an incredible time at #CPHI2024 in Milan! We had the pleasure of connecting with so many inspiring professionals and discussing how to accelerate innovation in the pharmaceutical industry. A huge thank you to everyone who stopped by booth 7G116 to meet with Nicole Hendriks, Norberto Bonalumi, Vania Santana, Juergen Rotzler, Stefan D., and Charlie Brault, MPS. Missed us at CPHI? Don’t worry—you can still reach out to our team for follow-up meetings. We’re here to help bring your innovation to its destination! #CPHIMilan