Biosimilar Manufacturing solution center

  1. 9 Reasons Why You Should Consider AI In Analytical Instrument Qualification 2/21/2025

    AI is about to completely change the analytical instrument qualification (AIQ) landscape in the pharma/biopharma and medical device industries.

  2. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

  3. Challenges And Opportunities Of Outsourcing Biopharma Development 2/19/2025

    Oversight, knowledge management, and operational/compliance risk make up the three key challenge classifications to consider when approaching a new outsourcing agreement.

  4. Consumables Are Leading The Cleanroom Market — Here's Why 2/19/2025

    As the industry expands, so, too does demand for PPE. This market analysis looks at the trends in consumables and other cleanroom technology used to make medicine.

  5. Tackling Encapsidated Host Cell DNA To Improve Quality 2/19/2025

    Discover a cell line that enhances rAAV production by reducing host cell DNA encapsidation, improving safety and efficiency through genetic modifications that inhibit apoptotic DNA fragmentation.

  6. Comparison Of WFI Production Methods: Multi-Effect Distillation Vs. Vapor Compression 2/18/2025

    The two most common hot water for injection (WFI) generation methods are multi-effect distillation (MED) and vapor compression (VC). There are significant differences in terms of operational principles and energy efficiency.

  7. Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis 2/18/2025

    Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.

  8. Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings 2/14/2025

    Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes.

  9. Emerging Trends In mAbs Manufacturing In 2025 And Beyond 2/11/2025

    Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics manufacturing.

  10. A Look At Pharmaceutical Inspection Machine Advanced Technologies 2/7/2025

    Pharma and biotech companies are increasingly using inspection machines with advanced technologies, such as x-ray inspection, robotics, and more, to help them get ahead of the competition.