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WHITE PAPERS AND CASE STUDIES

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• Development And Optimization Of Suspension-Adapted 293T Cell Line

  Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.

• 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.

• Pasteurized Equivalent Water Treatment At High Desert Milk, Idaho, US

  Learn how High Desert Milk, a cooperative in Idaho, optimized their water treatment process using HOD™ UV technology, ensuring FDA compliance while significantly reducing water and energy consumption.

• Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals

  VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

• Material Selection For Medical Device Manufacturability

  Choosing the right material in the earliest stages of research & development can make all the difference in beating your competitors to market and avoid increased project costs, development delays and manufacturing setbacks.

• Efficient Carbon And Ion Exchange Media Exchange

  This document outlines the essential steps required to exchange spent media, including disposal of spent media.

• 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.
• Using SerumSub™ QualAssure™ To Assess Liquid Transfer Performance

  In this study, SerumSub™ QualAssure™, a serum-like reference solution with liquid handling properties that are analogous to several commonly used sera, is compared to various commercially available mammalian sera.

• Custom Microscope Objective Case Study

  Melles Griot custom objectives deliver superior imaging, color correction, and system repeatability—tailored for demanding applications where standard microscope optics fall short.

• Alerion Microbubble Cell Separation System Used For T Cell Negative Selection

  Discover how the Alerion™ Microbubble Cell Separation System outperformed standard magnetic methods in T cell recovery, speed, and scalability — achieving higher cell quality with Akadeum’s innovative microbubble technology.