Biosimilar App Notes & Case Studies

1. Capillary Isoelectric Focusing (cIEF) As A Platform Method For The Evaluation Of Monoclonal Antibody Charge Variants 4/12/2021

   The determination of charge variants of therapeutic proteins is a regulatory requirement for pharmaceutical companies. This application note demonstrates the suitability of capillary isoelectric focusing (cIEF) to assess the charge heterogeneity of different types of monoclonal antibodies. Our results prove that the developed cIEF method can be used as a platform to obtain unique profiles for different IgGs and effectively resolve their charge variants, with enough sensitivity to identify differences between the innovator and its biosimilar.

2. Quality-by-Design Approach To Enable High-Dose Drug Delivery With Autoinjectors 5/12/2021

   Designing self-injection systems to deliver biological drugs into the subcutaneous space has specific challenges relative to those required for the safe and efficacious delivery of traditional pharmaceuticals. A quality by design approach can manage all the unavoidable competing requirements and balance performance, robustness, and usability.

3. Prepare For Future Viral Vector Manufacturing 3/1/2021

   Rethinking how we transition from translational clinical centers at smaller scale—using flasks and open systems—towards commercial production and methodologies.

4. Transforming Your Biopharma Automation Capabilities 6/24/2021

   Single-use technology equipped with a scalable distributed control system allows for collecting and sharing data while simultaneously creating a connected enterprise that grows with the pace of business.

5. Design Agile Manufacturing With An Integrated Drug Product Ecosystem 9/3/2021

   Companies wanting to accelerate biomanufacturing operations and use resources efficiently need access to technologies and solutions that can safely and efficiently complete workflow from idea to injection.

6. SARS-CoV-2 Impact To Biological Drug Products Safety 6/13/2022

   Review currently available literature and our recommended SARS-CoV-2 virus detection test methods and susceptibility of common biological host cells to infection.

7. Industrialization And Scale-Up Of Drug Delivery System 11/30/2020

   A pharma company and its product design partner were in need of a contract manufacturer able to support its device development, injection molding, tooling, logistics, and scale-up automation strategy. 

8. In-House Manufacturing: Key To Driving A Diabetes Vaccine? 1/28/2022

   Increasing constraints on today’s supply chain from the COVID-19 pandemic mean drug companies must secure strategies that can ensure product delivery in the face of these challenges.

9. Optimizing Feed Strategies: A Scalable Process 4/1/2022

   We present an optimized feeding strategy and demonstrate how a new, easy-to-hydrate, single-part, pH neutral feed can support optimal cell growth and high productivity of CHO cell lines.

10. Intensified, Improved Fed-Batch Production Process 5/13/2021

    The method described here allows you to intensify your fed-batch process through reduced production duration without affecting the growth or titer profile.