Biosimilar White Papers

  1. CMC Strategies For A Bispecific Antibody Platform For Cancer Immunotherapy 5/31/2019

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process. 

  2. Quality Matters – SEC Analysis For Antibody Aggregates 10/25/2019

    Size exclusion chromatography is the go-to analytical method for therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

  3. Trends In Protein Separation And Analysis — The Advance Of Stain-Free Technology 4/7/2020

    Stain-free technology, a technology that existed in principle since early 2000 but was only commercialized in 2010 has changed the protein separation and analysis landscape in the past few years. This article focuses on how protein visualization is accomplished using stain-free technology, its advantages and concerns as well as how stain-free technology can change the way we carry out protein separation and analysis.

  4. A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand 5/30/2019

    An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.

  5. LV Scale-Up Workflow In Single-Use Bioreactors For GMP Compliance 11/8/2019

    Cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.

  6. Gene Selection Using PrimePCR Plates And CFX Maestro Software 4/7/2020

    Reference gene selection and validation are very important for gene expression studies that involve different samples or experimental conditions and therefore are absolutely necessary before any further exploration. Read how PrimePCR Reference Gene Selection Panels provide an easy-to-use system with which to select appropriate reference genes.

  7. The Use Of Cell-Free Synthesis In The Future Of Modern Medicine 4/2/2019

    Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.