Biosimilar White Papers

1. Understanding And Controlling Raw Material Variation In Cell Culture Media
   9/5/2019

   An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

2. 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.

3. Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective
   6/11/2019

   There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

4. Virus Safety For Continuous Processing
   9/5/2019

   Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.

5. Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process
   5/30/2019

   This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

6. Optimizing Process Efficiency In Upstream Manufacturing
   2/8/2019

   Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.

7. Critical Considerations About The Future Of Global Cell Culture Bioprocessing
   4/2/2019

   In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

8. Protein Analysis With Size Exclusion Chromatography (SEC)
   2/20/2018

   This white paper presents fundamentals about analytical SEC and describes how our new-generation agarose-based SEC columns are used in analysis of biomolecules.

9. Sensitive And Reproducible SPR-Based Concentration And Ligand-Binding Analyses
   3/27/2019

   Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.

10. Buffer Management Solutions For Large-Scale Bioprocessing
    2/1/2018

    How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.