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WHITE PAPERS AND CASE STUDIES

• Life Sciences Corporation Implements eLogbooks Across 15 Sites

  New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

• Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements

  Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

• 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.

• Next Generation Sequencing In Viral Safety Testing

  Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.

• Streamlining Study Start-Up For Accelerated Drug Development

  What is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.

• Immunogenicity Risk Assessment In Drug Candidate Selection

  Identify and address potential anti-drug immune responses early in development to streamline your drug’s path to clinical success—start smart and finish fast.

• Using Plant Peptones To Boost Plasmid Yield And Induction

  Uncover how Nu‑Tek’s plant-based peptones support E. coli growth, plasmid yield, and controlled induction, offering a sustainable, animal-free alternative for biopharmaceutical cell culture.

• Support Digital Transformation And Enable Collaboration Between Teams

  Discover the solution PharmaEssentia, a Taiwanese pharmaceutical company, chose to help teams capture, structure, and interrogate data from a single source, making their collaboration more efficient.

• Writing An IND Module 3 For Cell And Gene Therapy Products

  This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

• 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.

• How ABB Is Helping Optimize Combustion At Twence's Waste-To-Energy Plant

  Maintaining the right level of oxygen is crucial for combustion optimization. Too much excess oxygen equals decreased efficiency. Read more about how ABB is helping Twence optimize combustion in their waste-to-energy plant in the Netherlands.

• Clear MRSA Infections At Single Low Doses

  Multidrug-resistant bacteria are rendering antibiotics ineffective. Review preclinical results of a potent macrocycle derivative and why collaboration is crucial to transition discoveries into treatments.