White Papers

  1. Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records 12/7/2020

    Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

  2. Why Biopharma Lifecycle Management? 12/4/2020

    The biopharma industry has ambitions to accelerate industry 4.0.This white paper explores the major bottlenecks in the development lifecycle and the current barriers to effective digital transformation.

  3. Using Single-Use Connectors To Increase The Integrity Of Closed Systems 12/3/2020

    It is critical the single-use sterile connectors you select meet the sterility and reliability needs of your application, as minimizing the threat of contamination using a closed system is critical.

  4. Getting Your Investigational Drug Regulatory Ready 12/1/2020

    Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

  5. Quality By Design And Design Control Roadmap For Combination Products 11/30/2020

    Quality by Design (QbD) principles help to facilitate design of products and processes that maximize the product’s efficacy and safety profile, while enhancing product manufacturability. A proposed roadmap to utilize QbD principles in conjunction with design control requirements (21 CFR 820.30 and ISO 13485) for design and manufacture of drug-device combination products based on sound science and risk management is presented.

  6. Demystifying Performance Testing: Strategies To Qualify Combination Products 11/30/2020

    Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article presents a best practice strategy for performance testing. It starts with a thorough understanding of applicable regulations and guidances. Following this, performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed, considering highest risk failure modes first.

  7. Superior Biopharmaceutical Manufacturing Facilities Prioritize Cleaning & Disinfection During Design 11/20/2020

    Thorough consideration of cleaning/disinfection during facility design eases maintenance across the facility lifecycle, optimizes workspace utility, and contributes to efficient facility operation.

  8. How Can Outsourcing Buffer Preparation Help Meet The Urgent Need For A SARS-CoV-2 Vaccine? 11/16/2020

    As numerous therapeutic drug and vaccine candidates make their way through human clinical trials, companies are already planning for how to manufacture any successful molecule on a global scale. In this planning, the preparation of process liquids and buffers should be considered.

  9. Quantification Of Vector Genomic, Residual DNA In Gene Therapy Vectors 11/10/2020

    Bringing cell and gene therapy drugs to market requires improvement in many areas, including analytical testing methods, which are used to determine the safety, strength, and purity of viral vectors.

  10. Government Partnership Highlights Blow/Fill/Seal Advantages In Race For COVID-19 Vaccine 11/3/2020

    Continued global efforts to incorporate BFS in the safe and efficient delivery of life-saving vaccines are proof the technology serves as a valuable tool in improving patient care across the world.