Biosimilar App Notes & Case Studies

  1. Best Practices For A Successful Bioprocess Technology Transfer 9/10/2019

    A well-executed bioprocess technology transfer is critical to ensure smooth knowledge transfer and optimal process reproducibility. 

  2. Immuno-Oncology In Vitro Assays 4/12/2021

    Targeting immune checkpoints such as the PD-1 PD-L1 pathway has proven in recent years to be an effective treatment approach resulting in a range of approved mAbs that bind PD-1 or its ligand PD-L1. In this application note, we discuss our recently developed assay format to characterize checkpoint inhibitor mAbs, specifically discussing those that target the PD-1 PD-L1 pathway.

  3. Blazar™ Platform: Rodent Virus Panel From The BioReliance® Portfolio 3/12/2021

    Did you know about the alternative rapid method for in vivo MAP/HAP/RAP testing? Download our tech note Blazar™ Platform: Rodent Virus Panel From The BioReliance® Portfolio to learn more about our novel degenerate PCR assay designed for the detection of a broad range of adventitious agents.

  4. Robust Process Development For cGMP Manufacturing Of Cell Therapies 9/24/2020

    By leveraging early decisions around process development, quality assurance, and quality control strategies, you can set yourself up for a successful cGMP manufacturing workflow. 

  5. Optimizing Cell Culture Media: Increase Titer With Maintained Protein Quality 2/21/2020

    When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. Here's how the process improvement can be performed reliably.

  6. Cell Therapy Manufacturing Under GMP - How And When To Get Started 5/2/2019

    Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.

  7. How Collaboration Transformed A Generic Into A Best-In-Class New Drug 10/7/2020

    Learn how a drug developer collaborated to transform a generic solid active pharmaceutical ingredient (API) into a commercial, sterile injectable approved by regulators.

  8. Automated High Throughput mAb Purification Using Fibro Technology 4/21/2020

    Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based column.

  9. Purifying Tagged Proteins Using ÄKTA Go Protein Purification System 2/3/2020

    ÄKTA go is a small and compact liquid chromatography system that allows researchers to perform routine protein purification with ease while allowing for efficient use of bench and cold cabinet space.

  10. Pluripotent Stem Cell Expansion And Scale-Up 8/5/2020

    Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.