Biosimilar App Notes & Case Studies

31. Pandemic Demand Forces Rapidly Increased Production And Expertise 5/19/2021

    Solis BioDyne, one of the leading reagent suppliers in Europe, manufactures a ribonuclease inhibitor used in COVID-19 diagnostic tests. Previously manufactured at bench scale, the company now needed to quickly increase production 50-fold to meet demand.

32. AAV Production Using Microcarriers 6/2/2021

    Scientists have successfully adapted an adherent HEK293 cell line to grow in animal component-free and serum-free suspension conditions in shaker flasks. After comparing adherent, suspension, and microcarrier culture for AAV production, they believe that microcarrier culture is suitable for large-scale production of viral vectors to support future gene therapy manufacturing processes.

33. Enabling Broader Adoption Of Process Intensification In Biopharma 7/9/2021

    PI is becoming increasingly well-understood and its utility is continuously evolving to meet specific manufacturer needs, from product development to manufacturing, whether approached stepwise or end-to-end.

34. Increased Productivity With Concentrated Fed-Batch 6/7/2021

    A large biopharma company wanted to establish a single-use multi-product facility by choosing appropriate upstream processes that can deliver more than 500 kg/year throughput. This case study shows how a concentrated fed-batch process was established, enabling higher productivity and increasing the throughput (up to 4× higher titer than standard fed-batch), providing more flexibility for production runs.

35. Consistency And Compliance Through Cell Therapy Automation Software 4/30/2021

    As automation offers new options for flexibility and optimized production in biologic production, exploring its use in advanced therapy manufacturing to improve safety, quality, and compliance becomes a key factor in advancing patient care.

36. Improving Lentiviral Vector Downstream Processing Workflows 8/5/2020

    Lentiviral vectors (LVV) are a common vehicle to deliver genetic material in CAR T cell therapy and gene therapy applications. Production methods have been developed by adapting technologies from the bioprocessing sector. However, these downstream workflows are long, require substantial manual labor, and suffer from low yields of infectious virus. In this article we discuss process development pain points of a modern workflow and ways to address them.

37. Platform Cell And Gene Therapy Media Development 9/9/2020

    This article highlights a case study on the removal of serum from the expansion step of an autologous cell therapy in a cost-effective manner without affecting cell performance.

38. Purification Of mRNA By Affinity Chromatography On CIMmultus® Oligo dT Column 6/7/2021

    Increasing demand for messenger RNA (mRNA) as therapeutic product requires efficient and scalable purification methods. In this application note a CIMmultus® Oligo dT, a monolithic stationary phase is used for purification of mRNA from a capping mix of Luc2 RNA. The large channels and convective mass transfer within the stationary phase eliminate shear forces and allow high flow rates, which leads to very short purification times and high recoveries.

39. The Value Of A BD Integrated System For Combination Products 7/24/2020

    The growing complexity and regulatory rigour of combination products has called for increasingly innovative delivery devices. This article looks at the advantages of using an integrated system for these drug-device combination products rather than sourcing components from different suppliers.

40. An End-To-End, Semi-Continuous Process For mAb Production 9/22/2019

    See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.