Biosimilar App Notes & Case Studies

  1. 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.

  2. Capture Of Histidine-Tagged Molecules Using Biacore His Capture Kit 10/21/2021

    Find recommendations for immobilization of histidine-tagged molecules (ligands) by capture to an anti-histidine antibody covalently coupled to a sensor chip surface.

  3. Platform Cell And Gene Therapy Media Development 9/9/2020

    This article highlights a case study on the removal of serum from the expansion step of an autologous cell therapy in a cost-effective manner without affecting cell performance.

  4. Regulatory Challenges For Viral Vectors For Cell And Gene Therapy 7/24/2020

    Frost & Sullivan's Virtual Think Tank series brought together leading minds in the cell & gene space to discuss current regulatory issues and key challenges in viral vector manufacturing.

  5. Building An Army: Cell Therapy Platforms With Dr. Helen Sabzevari, CEO Of Precigen 8/18/2021

    Two of the biggest challenges facing the cell and gene therapy space today — controlling costs and optimizing scalability — have the potential to be addressed by companies through innovative, integrated technology solutions. In a recent episode of The Business of Biotech, Dr. Helen Sabzevari discussed how her company Precigen has used customized therapeutic and platform technologies to tackle scale-up in the CAR-T therapeutics space.

  6. Qualification Summary: Shippers For Celsius® FFT | FFTp 12L With Safecore™ Technology 6/11/2021

    Since it is not possible to anticipate every possible transport route, a set of industry-recognized tests was selected to represent a challenging use scenario. The two main risks to frozen material during transport are mechanical and thermal. In this note we have evaluated the  Celsius® FFT | FFTp Box Shipper and Celsius® FFT | FFTp Bulk Shipper using the ASTM D-4169 test for mechanical risks and the ISTA 7D test for thermal risks.

  7. Blazar Platform: Rodent Virus Panel 7/15/2020

    By amplifying multiple targets within a conserved region of the viral family genome, Blazar detects a much broader range of adventitious viruses as compared to traditional polymerase chain reaction methods.

  8. Pandemic Demand Forces Rapidly Increased Production And Expertise 5/19/2021

    Solis BioDyne, one of the leading reagent suppliers in Europe, manufactures a ribonuclease inhibitor used in COVID-19 diagnostic tests. Previously manufactured at bench scale, the company now needed to quickly increase production 50-fold to meet demand. Read the case study to learn how Solis BioDyne worked with Cytiva to meet the challenge.

  9. Prepare For Future Viral Vector Manufacturing 3/1/2021

    Rethinking how we transition from translational clinical centers at smaller scale—using flasks and open systems—towards commercial production and methodologies.

  10. Quality-by-Design Approach To Enable High-Dose Drug Delivery With Autoinjectors 5/12/2021

    Designing self-injection systems to deliver biological drugs into the subcutaneous space has specific challenges relative to those required for the safe and efficacious delivery of traditional pharmaceuticals. A quality by design approach can manage all the unavoidable competing requirements and balance performance, robustness, and usability.