LMS Volume 33 |ssue 4 | Page 19

Biotech & Pharma LMS  Issue 4 | 2014  19 Be Confident in your Results F or biopharmaceutical organisations challenged to deploy high-resolution analytics across the innovative biotherapeutic or biosimilar development process, Waters’ Biopharmaceutical Platform Solution with UNIFI® integrates robust UPLC/MS characterisation technology with comprehensive software for applications in bioseparations, intact protein mass analysis, peptide mapping and released glycan analysis. The platform enables a laboratory to comprehensively acquire process and report LC and MS characterisation data throughout a biotherapeutic’s development lifecycle. From bioseparations to LC/MS characterisation, the Biopharmaceutical Platform Solution provides detailed workflows that enable results to be readily shared from discovery to development to GxP quality control laboratories. The platform increases confidence in the results - confidence that one has obtained the best results for development decisions, and confidence that one has the information necessary to address regulatory requirements. At the heart of this platform is the UNIFI Scientific Information System, which is the first software to merge LC and MS data in a single solution that encompasses data processing, visualisation, and reporting and configurable compliance tools. The GlycoBase database of glucose unit values  is now integrated as a library within UNIFI. The platform supports a mix of quadrupole time-of-flight MS and optical detection instruments within a networked laboratory workgroup. The ability to deploy UNIFI-based systems within regulated or nonregulated laboratories provides companies the flexibility to employ high resolution UPLC bioseparations and high performance mass analysis. ⚛ Microsep Contact: Louis van Huyssteen Tel: 011-553‑2300 Email: [email protected] Electrolab 14 T he most effective and perfect tool for R&D, QC and BE studies is the Electrolab 14 place dissolution tester. According to the South African FDA regulations this tester should be used so that there is no need to make bio-availability studies again. The dissolution tester includes temperature monitoring of all 14 vessels with motorised driving manifold and a tablet input device as an option. One of the most advanced dissolution testers for the pharmaceutical industry today, it also facilitates online/offline automation. Additional features include: • Time saving tool for S1, S2, S3 • Complies with USP, IP, Ph. Eur. specifications • Supports USP I, USP II, USP V and USP VI test methods • 20 programmable protocols +