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WHITE PAPERS AND CASE STUDIES

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• Keeping The Lights On With Wolfspeed SiC

  Introducing the “M” inverter, a modular, silicon carbide-based solution that optimizes utility-scale energy storage with higher efficiency, reliability, and scalability.

• How Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• Prioritize Process Validation To Mitigate Manufacturing Risks

  Medical device manufacturers must prioritize process validation to ensure safe and effective performance. Neglecting this can lead to severe consequences. This article covers essential elements of process validation due diligence.

• Process Development For Lyophilized Products

  Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

• Patient Perspectives On eConsent

  Explore how eConsent enables participants to engage meaningfully with consent documentation, addressing information dissemination, explanation, and recall challenges.

• 8 Ways To Achieve Higher ROI In Quality

  Is your company still using outdated methods for its QMS? It's time to evolve. Uncover how an integrated QMS can streamline operations, enhance compliance, and support your company's growth.

• Cancer Research UK's Path To Rave EDC And The Medidata Platform

  Discover how Cancer Research UK, the world's largest cancer charity, upgraded to Medidata's Rave EDC platform, streamlining clinical trials and enhancing productivity while ensuring minimal disruption.

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

• Methods For Determining Equipment Capability Of Freeze-Dryers

  Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.

• 5 Steps To Design A Microbiological Performance Qualification For Facilities Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
• A Feeder-Free Platform For Generating Mature Natural Killer Cells

  NK cells represent a promising avenue for immunotherapy. Examine the advantages of NK cells in cellular immunotherapy and the importance of developing efficient activation and expansion platforms.