Biosimilar White Papers

1. CDMO Collaboration: Foundation For Sterile Injectable Product Success 6/1/2021

   Explore how a small or medium size biotech or pharma company eveloping sterile injectables can benefit from the experience and assistance provided by a CDMO.

2. Facilitating 21 CFR Part 11 Compliance With Bioprocessing Automation Software 8/16/2021

   How Bio4C Orchestrator™ Software provides technology to support requirements for electronic records and provides a detailed “rule-by-rule” analysis for 21 CFR Part 11 and Annex 11 in tabular form.

3. Cell Therapy Scale-Up Strategies For Commercial Success 9/30/2020

   This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development.

4. A Guide To Accelerating Cell Line Development For Commercial Production 8/11/2021

   Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.

5. 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!

6. 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.

7. Ensuring Consistency In The Supply Of Cell Culture Media 12/16/2020

   This paper describes a robust, global manufacturing network for cell culture media that supports capacity expansion to meet growing demand and ensure business continuity.

8. Considerations For Improving Outcomes In Biopharmaceutical Process Development 8/12/2020

   In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.

9. Demystifying Performance Testing: Strategies To Qualify Combination Products 11/30/2020

   Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article starts with applicable regulations and guidances, and then performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed.

10. Analytical Power Tools Open Upstream Bioprocessing Bottlenecks 10/5/2021

    Researchers using analytical power tools can reach their goals faster and shorten the bench-to-bedside development path, benefitting both patients and the bottom line.