Business Process Management

WHITE PAPERS AND CASE STUDIES

• Compliance Tips For New Medical Device Products

  How can you guarantee that your medical device will not only perform as designed, but also conform to the highest regulatory standards? By designing for compliance you can meet this goal.

• Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process

  This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

• Understanding And Controlling Raw Material Variation In Cell Culture Media

  An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

• Keeping Your Additive Manufacturing Laser In Spec

  Additive manufacturing allows for more customized parts using more specialized materials, and will eventually create a more localized, rapid, and agile distribution network. This white paper discusses important laser performance characteristics, how to measure them, and how to keep the laser in spec.

• Optimizing Process Efficiency In Upstream Manufacturing

  Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.

• Viral Clearance: The Basics On How To Conduct Effective Studies

  Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

• AR Helps Diversey Overcome Service Barriers And Build Customer Relationships

  Diversey is the industry leader of smart, sustainable solutions for cleaning and hygiene in both B2B and B2C markets. Diversey has been, and always will be, a pioneer and facilitator for life. They constantly deliver revolutionary cleaning and hygiene technologies that provide total confidence to their customers across all of their global sectors. Headquartered in Charlotte, North Carolina, USA, Diversey employs approximately 9,000 people globally, with net sales of approximately $2.6 billion in 2017.

• Business Continuity Program: Maintain Operations During Crises

  Get 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.

• TIBCO Spotfire® As Essential Tool At Major Global Pharmaceutical Company

  A pharmaceutical company first was looking to deploy a software solution for a small group of R&D users for analyzing research data. Read how the TIBCO Spotfire®, an enterprise-class visualization and analytics platform, allowed them to exploit an array of functionality, from chemical structure analysis to statistical modeling, to build dashboards and visualizations that maximize understanding of R&D data.

• An Overview Of The ICH E6 (R2) Guideline

  While the revisions to the guideline mainly impact sponsors, technology providers and contract research organizations need to be aware of the changes and make adjustments to operational procedures, documentation practices, quality approaches and computerized system functionality.

• Evolving Containment In Pharma Manufacturing Facilities

  Pharmaceutical manufacturing is now undergoing significant transformation. COVID-19 and its pressure on nearly every aspect of human life has put a gigantic emphasis on rapid development of prescriptives, vaccines, and accelerated means for pharmaceutical mass-production. This paper characterizes the new production directions in pharmacy and describes flexible equipment to improve pharma efficiency, purity, and production safety in the coming decade.

• Process Characterization: Ready For The FDA?

  Realizing the benefits of process characterization requires proper planning and application of a comprehensive process characterization strategy.