Biosimilar Manufacturing solution center

  1. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

    Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

  2. Benchmarking Filtration Performance Of TFF Cassettes 5/30/2025

    Optimize your protein purification workflow with tangential flow filtration by comparing membrane performance and exploring how protein concentration impacts flux and MWCO selection in lab-scale systems.

  3. Cross Flow Filtration Method Handbook 5/22/2025

    Discover the principles and applications of cross-flow filtration using advanced technologies, as well as learn practical steps, operational tips, and industry insights for optimal filter performance and longevity.

  4. How APBio Builds Multispecific Analytical Target Profiles 5/22/2025

    Some attributes require an elevated level of attention, in particular when it comes to analyzing chain pairing, folding fidelity, and aggregation.

  5. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

    The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

  6. Formulation Is Key For Y-mAbs' Self-Assembling Antibody 5/16/2025

    The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

  7. Cost And Scalability Key Drivers Of Expanded Gene Therapy Access 5/16/2025

    Gene therapies are expanding beyond rare diseases, but high costs hinder access. Discover how innovations in viral vector manufacturing could make these breakthroughs more affordable.

  8. AI's Potential To Aid Multispecific Analytical Characterization 5/16/2025

    Orthogonal analytical techniques are essential to characterize CQAs, support regulatory submissions, and validate AI-predicted formulation strategies.

     

  9. Using AI To Predict Multispecific Formulation Patterns 5/16/2025

    This emerging class brings substantial formulation challenges beyond those of traditional mAbs. Here’s a comprehensive look at the issues and some solutions.

  10. A Shift Towards Biofluorescent Particle Counters In Manufacturing 5/12/2025

    Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.