by Jeffrey Wotton | Sep 8, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting, Quality Control
Embracing Digital Twins in Biopharma Manufacturing: Enhancing Quality and Efficiency The biopharmaceutical industry continues to evolve, driven by the need for more efficient production, higher quality standards, and compliance with stringent regulatory requirements....
by Jeffrey Wotton | Aug 29, 2025 | Biopharma Consultant, Biotech Consulting, GMP Good Manufacturing Practices, Insights, Pharma Consulting, Primary Reference Standard, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
The Critical Role of Gap Assessment in Reference Standard Qualification Programs In the biopharmaceutical industry, the establishment of Primary Reference Standards (PRS) and Working Reference Standards (WRS) is a cornerstone of quality control, regulatory compliance,...
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, Quality Control, 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 | Aug 13, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Understanding the Importance of Working Standard Qualification in Biopharmaceutical Manufacturing In the highly regulated world of biopharmaceutical manufacturing, precision, consistency, and compliance are non-negotiable. One critical element in achieving these...
by Jeffrey Wotton | Jul 21, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Understanding Primary Reference Standards (PRS) in Pharmaceutical Development Why Primary Reference Standards Are the Cornerstone of Reliable Analytical Testing in Pharma. In the pharmaceutical industry, accuracy and consistency are non-negotiable. One critical...
