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WHITE PAPERS AND CASE STUDIES

• Expand Bandwidth With A Trusted Regulatory Writing Partner

  Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

• UV Disinfection And Dechlorination At Cottonseed Processing Facility In Texas, US

  The Archer Daniels Midland Company (ADM) requires full-scale nonchemical disinfection and dechlorination treatment of RO feedwater to the boiler which supports their cottonseed processing facility in Lubbock, Texas.

• Optimizing Poloxamer 188

  Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.

• How To Unlock The Secret To Repeatable, Scalable Low Turnover

  Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.

• Advanced Mobile Lab For Rapid Disease Response

  Discover how this mobile lab enhances rapid outbreak response and safely manages highly infectious pathogens, showcasing Germfree's expertise in biocontainment solutions for critical health crises.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.

• Industrial Smart Components: What To Use When

  The objective of this paper is to provide an overview of the current standard industrial HID Global RFID tag portfolio and provide a guideline of the RFID tag family’s main propositions.

• Optimized Fill And Finish To Limit DMSO's Negative Impact On T Cells

  In order to improve the existing cryopreservation paradigm, operators must consider fill/finish and cryopreservation techniques that streamline processing steps and minimize cells’ exposure to DMSO.

• Matters of Scale: Centralized vs. Decentralized Manufacturing Of Advanced Therapies

  Reducing human intervention and manual processes in advanced therapy manufacturing is critical to improving a manufacturing paradigm, safeguarding quality, simplifying processes, and improving efficacy.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• Random And Semi-Targeted Integration In Cell Line Development

  While semi-targeted approaches may offer precision, uncover how they may fall short in overall efficiency and productivity, especially in late-stage manufacturing.

• 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.