Newsletter | June 8, 2019

06.08.19 -- Techniques For Risk-Based Validation Using ASTM E2500

Featured Editorial
Techniques For Risk-Based Validation Using ASTM E2500
By Michele Levenson, Pharmatech Associates

ASTM standard E2500, Specification, Design, and Verification of Pharma and Biopharma Manufacturing Systems and Equipment, elevates risk-based validation as a critical aspect of GMP manufacturing. This article explores validation’s role in efficiency and cost management, in an approach to ASTM E2500 from a scientific, value-added perspective.

Military Tool For Biopharma Vulnerability Assessment: The CARVER + Shock Technique
By Mark Durivage, Quality Systems Compliance LLC

CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.

Gene Therapy: Commercial Challenges And Strategic Choices
By Ricardo Brau and Pierre Jacquet, L.E.K. Consulting
Mystery And Danger: Flammables And Oxidizers In Pharma Filling Operations
By Erich H. Bozenhardt and Herman F. Bozenhardt
6 Regulatory Changes Affecting Bioprocessing In China
By Scott M. Wheelwright, Complya Asia
How To Design Cell-Based Potency Assays
By Aryo Nikopour and Ming Li, Ph.D.
Volume Reduction And Process Optimization With Inline Concentrator
By Catherine Casey, M.Sc., and Engin Ayturk, Ph.D.
Vero Perfusion, Packed-Bed Vessels Intensify Vaccine Production
By Xiaofeng (Kevin) Han, Ph.D., Ulrike Becken, Dr.rer.nat., and Ma Sha, Ph.D.
Mycoplasma Contamination: Understand The Risks, Take On The Challenges
By Guy Matthews and Dr Carolyn Heslop
Inaccurate Forecasting Is Here To Stay: Focus On Managing Risk Instead
Thermo Fisher Scientific
Enhanced Assurance Of Quality Supply For Single-Use Predesigned Solutions
Sartorius Stedim Biotech
Small Molecule Impurities Represent A Key Challenge When Designing Control Systems For ADC Therapeutic Manufacture