Cleanroom Whitepapers and Case Studies

  1. Understanding Viral Clearance During Anion-Exchange Chromatography 3/26/2024

    A design of experiments (DoE) study examined the anion-exchange process in general and to draw possible correlations between such properties and overall viral clearance capability.

  2. Spray Drying To Enable New Inhaled Drug Products 7/11/2023

    The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or rapid onset therapeutic.

  3. Is Sustainability The Key To Agile Biopharma Manufacturing? 3/18/2025

    In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

  4. Clinical Phase Manufacturing With A Self-Contained Cleanroom Facility 6/19/2024

    Explore the development of a mobile Biosafety Level 2+ (BSL-2+) facility adhering to cGMP for early-phase clinical trial manufacturing.

  5. Live Biotherapeutic Products: Unique Quality, Manufacturing, And Nonclinical Considerations For Clinical Trial Entry 7/8/2025

    Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease.

  6. Development Of Endothelial-Cord Cell Banks And Blood Stem Cell Products 5/28/2025

    Leverage our proven cGMP expertise in cell therapy manufacturing, from primary tissue processing to large-scale production for clinical trials.

  7. Robust, Scalable Strategy For Monodisperse Nanosuspensions Of Poorly Soluble Drugs 5/16/2025

    By tailoring the formulation strategy, selecting the appropriate excipients, and fine-tuning process conditions, see how our team was able to improve bioavailability and in vivo exposure.

  8. Sterile Filtration And Quality Risk Management 8/31/2023

    Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.

  9. Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing 6/13/2025

    Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.

  10. Comprehensive Compressed Air Assessments: The 5-Step Process 10/10/2024

    The objective of this paper is to define the five steps required in a compressed air assessment. We will use a real-world example with system information from a magnetic materials manufacturer to clearly illustrate each step.