by Jeffrey Wotton | Aug 29, 2025 | Biopharma Consultant, Biotech Consulting, Case Study, GMP Good Manufacturing Practices, Insights, Pharma Consulting, Primary Reference Standard, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Implementation of Primary Reference Standard and Working Reference Standard Procedures in a Biopharmaceutical Company A case study from BioPharma Consulting Group Background Biopharmaceutical Company A, a mid-sized company specializing in monoclonal antibody...
by Jeffrey Wotton | Oct 23, 2023 | Case Study, Working Reference Standard, Working standard qualification
Creating Working Reference Standard (WRS) Qualification Protocols Approved and ready to use WRS qualification protocols significantly reduce workload, time and resources when transitioning from one WRS lot to another. Primary reference standards (PRS), secondary...