Biosimilar White Papers

1. Addressing New Chromatography Challenges With Fiber Absorbents 6/2/2019

   An absorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and aims to address the capacity issues.

2. Mechanistic Modeling Of Chromatography To Speed Up Process Development And Provide Improved Processes 3/2/2020

   Catch up on the current opportunities and challenges for using mechanistic modeling to simulate and predict chromatographic behavior and experiments in silico. 

3. Benefits And Challenges Of Driving Modernization In Vaccine Development 6/11/2019

   Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

4. How Buffer pH And NaCl Affect Size Exclusion Chromatography 4/22/2020

   Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.

5. 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.

6. 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.

7. Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up 2/11/2020

   In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.

8. 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.

9. 6 Regulatory Changes Affecting Bioprocessing In China 4/2/2019

   This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

10. Digital Manufacturing Of Biologics 2/19/2019

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities.