FEATURED ARTICLES

• Knowledge Management — Opportunities & Challenges For Legacy Drug Products

  This article will explore specific challenges of managing knowledge in a legacy manufacturing environment and propose viable, practical solutions that have been found to be effective. These solutions allow practitioners to increase product and process understanding as well as performance.

• 2 (Major) Impediments To Faster Biopharmaceutical Product Development
• Identifying, Documenting, & Auditing Processes For Quality Management
• Put Your Continued Process Verification (CPV) Data To Work
• Working With Two Consultants On One QMS Overhaul: What Could Go Wrong?

WHITE PAPERS & CASE STUDIES

• Robust Business Continuity Program Helps To Maintain Operations In The Face Of Crisis

  Experts at Cytiva provide insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

• What You Need To Know About Process Characterization And Validation For Biologic Processes

  Process characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.

• When Clean Is Critical—Understanding Parameters And Definitions Of Clean

  Clean room environments necessitate high-quality materials and equipment that conform to a variety of specified standards. This white paper explains how clean parameters are defined and validated.

• Smarter Flowmeters For Filling Applications

  RONCHI MARIO developed its new filler around Endress+Hauser's new Dosimag and Dosimass flowmeters. The new filling machine generation of RONCHI MARIO S.p.A. features major innovations. Endress+Hauser's Dosimag and Dosimass flowmeters with integrated batching functionality are key components of the new machine concept.

• Calibration Management Increases Plant Availability

  Thanks to the set-up of a result-based calibration contract with Endress+Hauser and to the simplification of the operation, this major biotechnology plant has significantly reduced overall effort and calibration costs. The calibration time has also decreased, with positive impact on the plant process’s availability rate.

• External Management Improves Operational Quality

  A biotechnology plant was struggling with the management of the calibration of the more than 100 reference standards covered about 20 calibration service providers.