Biosimilar White Papers

1. Meeting Diverse Biologic Pipeline Process Development Challenges 9/10/2020

   The biopharma manufacturing industry has been evolving at an unmatched pace. Understanding and managing diverse molecule challenges is key to ensuring they reach patients safely and efficiently.  

2. Accelerate CHO Cell Characterization With The Blazar™ Rodent Panel: A Guide For Adoption 2/24/2021

   The development of the Blazar™ Rodent Panel allows biopharma to move away from traditional in vivo antibody production assays when characterizing cell banks of rodent origin used in the production of biologicals.

3. Liposomal And Nanoparticle Technology At Pfizer Melbourne 4/22/2021

   In recent years, liposome technologies have become an important part of the drug delivery armory, with several marketed products now available for use and many more formulations being evaluated in clinical trials.

4. Generating A Quality Attribute Profile For Antibody-Based Biosimilars: Assessing Differences In Fc-Associated Effector Functions 4/13/2021

   During biosimilar drug characterization, the use of orthogonal methods is necessary in providing a complete, detailed overview of the molecule being assessed – Surface Plasmon Resonance (SPR) assays allow for the description of an interaction by both kinetics and affinity, and are able to generate a wealth of information per sample assessment. Here, we review the use of the Sensorgram Comparison tool of the Biacore T200 software in two separate case studies, to detail instances where the affinity (KD) measurements and the binding responses did not sufficiently describe the drug substance interaction to the associated ligand.

5. Business Continuity Program: Maintain Operations During Crises 5/5/2020

   Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

6. Leading The Edge Of Innovation Into Cell Culture Media Quality 12/16/2020

   In this white paper, we highlight the breadth of programs implemented across our organization to safeguard the quality of the cell culture media that are used in our customer processes.

7. 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.

8. Strategies For Upstream Intensification 8/14/2020

   Upstream intensification is one strategy that will enable the Facility Of The Future by significantly driving down costs through an increase in volumetric productivity. Read the white paper to learn more!

9. Rapid Biosafety Testing Enables The Future Of Manufacturing 7/15/2020

   This whitepaper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing that are more aligned with manufacturing trends.

10. Single-Use Systems For Vaccine Manufacturing 10/29/2019

    Next-gen vaccines will leverage recombinant approaches and intensified single-use systems (SUS) to increase capacity at reduced costs, but SUS suppliers will need to overcome regulatory challenges.