Biosimilar App Notes & Case Studies

  1. 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.

  2. Selecting Drug Delivery Systems For Higher Doses, Higher Viscosities, And Lower Risk 1/18/2022

    Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

  3. Cellvento® 4CHO Fed-batch Medium 4/26/2021

    Different CHO hosts are used routinely to develop such biologics and are combined with several expression system like the dhfr, the UCOE or the glutamine synthetase (GS) system. The platform described in this process guidance was developed to grow a broad range of CHO cells. The production medium supports initial cell growth and production while the highly concentrated, neutral pH feed is added to replenish depleted nutrients required for cellular function and to maintain and extend the production phase in fed-batch mode.

  4. A Model To Increase Yield In mAb Cell Culture Perfusion At Large Scale 9/28/2020

    As process intensification is adopted into large scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows. 

  5. The Cell & Gene Talent Crunch: Attracting Top-Notch Employees In A Competitive Landscape 8/5/2021

    The question of how to develop, attract, and retain an advanced therapy, development, manufacturing, and clinical workforce is especially important for emerging biopharma companies. Michael Mehler shares valuable insights into what it takes to identify and draw a trained workforce to your doorstep.

  6. 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.

  7. Virus Retention Performance Under A Range Of Processing Conditions 8/12/2021

    Virus filtration is a critical operation in many biologic production processes and a key component of most viral safety strategies. 

  8. Comparison Of HIC Monolithic Support For Sample Displacement Chromatography Of pDNA 8/27/2021

    Competing adsorption in sample displacement chromatography utilizes the chromatographic resin's binding capacity more efficiently and increases the chromatographic step's productivity. This application note investigates three monolithic chromatographic supports with different hydrophobicities regarding their applicability for sample displacement of pDNA. CIMac™ C4 HLD (butyl, high ligand density) as a commercial product and pyridine and histamine as custom immobilised columns are compared.

  9. How Collaboration Transformed A Generic Into A Best-In-Class New Drug 10/7/2020

    Learn how a drug developer collaborated to transform a generic solid active pharmaceutical ingredient (API) into a commercial, sterile injectable approved by regulators.

  10. Intensified Seed Train Strategy For Faster, Cost-Effective Scale-Up Of Biologics Manufacturing 5/12/2021

    The biopharmaceutical industry is looking at process intensification as a means to cost-effectively produce monoclonal antibodies (mAbs). This article explores intensified processing of Chinese hamster ovary clones in the seed train of upstream cell cultures to support generation of high-cell-density cell banks and increased production of mAbs.