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WHITE PAPERS AND CASE STUDIES

• FDA Recommendations For Gene Therapy For PMDs

  Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

• Manufacturer Maximizes Yield and Increases Capacity With Filtration Solution

  Explore the benefits a cider mill producing 20 million liters of cider annually realized upon implementation of the Oenoflow High Solids system to recover additional alcohol from their cider lees.

• Sulzer Mixers Designed To Tackle Digested Sludge

  Discover how a wastewater treatment plant solved its mixing problem that was caused by the high sludge content. 

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

• Acoustic Inspection Helps Campbell River Optimize Inspection Program

  In this case study, explore how incorporating the SL-RAT into their maintenance program has realized significant savings for the city of Campbell River.

• Medical Device Manufacturer Implements A Next-Gen MES

  A medical device manufacturer raced to launch a new product in a greenfield facility to overcome tight timelines and compliance challenges by replacing paper SOPs with a dynamic digital solution.

• Facility-Fit-Driven Process Development For A Monoclonal Antibody

  See how proactively designing around plant constraints, using high-capacity resins, and leveraging parallel workstreams resulted in a 50% reduction in processing hours and 25% lower costs.

• Cell And Gene Therapy Field Quiet In Q2

  While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.

• 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.

• Patient Insights Informed Consent Engagement

  By incorporating the patient viewpoint throughout the informed consent process, discover how this technical solution enhanced the overall patient experience within clinical research operations.

• 6 HUBER Coarse Screen TrashMax® For Flood Protection In Houston, Texas

  In response to Hurricane Harvey, the Fort Bend, TX Levee District No. 2 embarked on a major upgrade project to increase the flow and capacity of one of its pump stations by 400%. The goal of the project was to protect the area around the district from 100- year floods in the future.

• Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors

  Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.