Biosimilar App Notes & Case Studies

1. Process Considerations For Closed Connected Processing 12/22/2020

   By giving examples for the implementation of closed, connected processing in large-scale manufacturing, this paper will help you explore and assess options that work for your objectives.

2. Fundamentals Of Size Exclusion Chromatography 5/20/2021

   SEC, also known as gel filtration, can be used for preparative and analytical studies of your protein. But how do you know which parameters give you the best resolution of your protein mixture?

3. Executing A Closed Connected Process From Start To Finish 12/22/2020

   This article provides recommendations from the execution of a closed and connected mAb process, from design considerations to scale-up, including the small-scale modeling that directed our manufacturing scale processes.

4. AVROBIO’s Geoff MacKay On Cell & Gene Scalability 10/4/2021

   Geoff MacKay, president and CEO of AVROBIO, talks with The Business of Biotech podcast about the scale up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.

5. Optimizing Recovery On The Sepax™ Cell Processing System 7/21/2022

   Using a model T-cell line, we demonstrate the impact of varying rinse volume, intermediate volume, and manual extraction parameters on overall cell recovery with a final product dose volume of 20 mL.

6. Impact Of A Chemically Defined Medium For Vero Cells Cultivation And Virus Production For Vaccine Applications 4/9/2021

   In the race to create serum-free, chemically defined media, research efforts have focused on identifying the elements required for superior growth performance. This include growth factors, hormones, carrier proteins, lipids, transition metals, vitamins, polyamines, and adhesion factors. This application note describes 4Cell® NutriVero™ Flex 10, a new Vero cell medium that is serum-free, chemically defined, and animal component-free. 4Cell® NutriVero™ Flex 10 delivers performance that matches conventional media with undefined hydrolysate supplementation.

7. 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.

8. Quantitation Of Retrovirus-Like Particles (RVLPs) In CHO Derived Products 3/11/2022

   Review key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method.

9. Accelerating cGMP Production Using Rapid Tech Transfer 4/1/2021

   A partnership between Cytiva and Teva Pharmaceuticals showcases tech transfer success through effective communication, diligent project management, and a wide range of expertise.

10. How Pattern Search Finds Anomaly Patterns In Historical Machine Data 10/21/2020

    Owing to the sheer volume of data streaming from sensor profiles, anomalies observed during process monitoring in historical data are extremely difficult to search due to a lack of time series search tools.