Bioprocessing White Papers

1. What You Need To Know About Process Characterization And Validation For Biologic Processes 4/3/2020

   Process characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.

2. Labtainer Pro BPC Extractables Profile 4/1/2020

   Single-use technology (SUT) products are beneficial in the manufacturing of vaccines and biologics. With the introduction of the Thermo Scientific™ Labtainer™ Pro BPC, Thermo Fisher Scientific offers a compilation of the standard BPC assemblies for use in conjunction with other bioprocessing products.

3. Labtainer Pro BioProcess Container (BPC) Quality And Integrity Testing 3/31/2020

   As technology advances and innovation takes place within the bioproduction industry, single-use technologies have become more common within the drug and vaccine manufacturing space. The Thermo Scientific™ Labtainer™ Pro BPC was developed to meet a variety of bioproduction workflow needs—providing improved ease of use, increased flexibility, and assured quality—without compromise.

4. Designing Quality Into Chromatography Resins To Minimize Variability 3/31/2020

   Chromatography resins and adsorptive membranes occupy a central role in the downstream purification of biologics and as such, the raw materials and processes used to manufacture these materials directly impact their performance. Assurance of quality and lot-to-lot consistency begins at the earliest stages of the research and process development phases, when new resins and membranes are being conceptualized and designed to meet the evolving needs of our customers. This article explores the strategies and close collaboration employed by MilliporeSigma to design quality into resins and membranes and to help customers minimize variability in their purification process.

5. Alternatives To In Vivo Assays For Biosafety Testing Of Biologics 3/31/2020

   The use of animal models for the detection of adventitious agents has been a feature of biologic testing packages for many decades. However, as alternative methods such as PCR and NGS have emerged these in vivo tests have stubbornly remained a central part of testing. Here we examine the current in vivo methods and explore alternatives which can be employed today.

6. Strengthening Your Chromatography Resin Supply Chain By Increasing Transparency And Control 3/31/2020

   This white paper explores key components of our chromatography resin supply chain program which help customers control their supply chains as they seek to ensure steady progress towards their next milestone and consistent availability of medicines for patients in need.

7. Introduction To Mass Transfer In Single-Use Bioreactors 3/27/2020

   Mass transfer in single-use bioreactors is complex and often misunderstood, yet critical to the growth of cells in culture, This paper aims to elucidate the standard mass transfer model.

8. A Molecule’s Journey - Break Down Roadblocks To Clinical Success 3/18/2020

   Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. In this guidebook, the experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety.

9. Seamlessly Transition From Transient Protein Expression To Bioproduction With The ExpiCHO System 3/16/2020

   As competition and growth in the biotherapeutic industry continues, the need to reduce cell line development costs and decrease time-to-market is more crucial than ever. The Gibco™ ExpiCHO™ Expression System enables the use of the same CHO host cell line from discovery through large-scale production, therefore shortening development timelines.

10. Perfusion - Design Of A High-Density Cell Culture Medium And The Positive Impact On Upstream Productivity And Economics 3/12/2020

    Perfusion-based upstream processes can address the need to attain higher volumetric productivity from upstream processes.by delivering higher volumetric productivities, increased flexibility and accelerate time to market. This white paper describes the development and testing of a cell culture media designed for use in perfusion processes.