Downloads

  1. From Lab To Large-Scale Process Validation: Mastering Regulatory Needs 10/9/2026

    Late-stage CMC planning for complex biologics begins with the end in mind. A structured approach to process characterization, built around product, timeline, and risk tolerance, shapes the path to BLA.

  2. Discover Accelerated Approaches For Successful Commercial Filing 10/9/2026

    Early risk assessment, leaner scale-down model qualification, and tighter process characterization scope offer the clearest time savings in microbial filings, each with scientific trade-offs worth weighing.

  3. Room To Grow: Exploring The Capabilities Of 15,000L Microbial Manufacturing 10/9/2026

    Large-scale microbial fermentation raises hard questions about scale-up, primary recovery, and capacity. A 15,000L multi-product setup in Switzerland addresses them within a broader range of cGMP scales, from 70L upward.

  4. Cell Culture Monitoring With An Innovative Analyzer 10/9/2026

    Evaluate the speed, precision, and consistency of automated bioanalyte testing, including sensor detection principles, quality controls, glucose, and lactate linearity.

  5. Method Evaluation Guidance For Transferring A Process 10/9/2026

    Moving a cell counting method between analyzers in a lab requires evidence of comparability. A structured study of suspension and adherent models tests precision and linearity against defined criteria.

  6. Steriles Express: GMP Clinical Batch In 20 Weeks 10/8/2026

    A contractually committed 20-week path from development to a Phase 1 or 2 GMP clinical batch, with delivery risk shared through a pay-for-performance structure for sterile vial products.

  7. Closed System Cell Culture Flasks 10/8/2026

    Closed, aseptic flasks in three surface areas support controlled cell expansion in therapy workflows, with sterile connections that carry seed trains into larger multilayer vessels.

  8. Determining ADCs Positional Isomer Distribution With Nonreduced CE-SDS 10/8/2026

    Drug-to-antibody ratio alone cannot show where a payload sits on an antibody. Pairing two orthogonal measurements, each blind to what the other sees, makes individual positional isomers resolvable.

  9. Developing Custom GMP Lipids: A Patient-Driven Partnership 10/8/2026

    Custom lipid programs depend on how process development and manufacturing teams collaborate, from first design through scale-up to GMP production for LNP-based therapies.

  10. Bridging Binder Discovery And Automated CAR T Cell Manufacturing 10/8/2026

    CLDN6-targeting CAR T cells for solid tumors move from binder discovery through manufacturing, with attention to how process design shapes technology transfer and consistency.