Bioprocessing White Papers

  1. Micro-Flow Imaging Enables Cutting Edge Biopharmaceutical Research 1/26/2021

    Protein aggregation and the formation of subvisible particles can significantly impact the safety and efficacy of biopharmaceuticals. Therefore, protein aggregation and subvisible particle content must be carefully monitored during in-process and final product development. Micro-Flow Imaging™ (MFI), a powerful system to analyze protein aggregates and other subvisible particles in your samples and can assess the stability of antibody-based biotherapeutics in response to stress

  2. Key Considerations To Developing A Disposable Grade-A Aseptic Fill/Finish Isolation System 1/19/2021

    Isolation of aseptic processes is not a new technology. Flexible Film isolation has been used in aseptic processing since the 1970’s but these systems tended to be a composite of stainless-steel chambers and airflow modules with a flexible film user interface. In this paper we are going to investigate how Solo Containment (Solo) developed a fully disposable aseptic isolation system.

  3. Bio4C™ ProcessPad 21 CFR Part 11 Compliance White Paper 1/12/2021

    To promote the use of state-of-the-art technologies while ensuring that these new software solutions meet the safeguards and regulations of traditional paper-based record keeping, the FDA issued 21 CFR Part 11 regulations to establish standards under which new electronic documentation and electronic signatures are regarded trustworthy and reliable. Bio4C™ ProcessPad software is a data visualization and analytics platform that securely acquires and stores batch processing and analytical testing data and makes the data available for investigations, reporting, and bioprocess monitoring. Bio4C™ ProcessPad facilitates 21 CFR Part 11 compliance by meeting applicable requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.

  4. Improve Biopharma Fermentation With Innovation, Collaboration 12/28/2020

    Many industry processes and parameters are still in the nascent stages of fermentation characteristic understanding, which is key to process development. 

  5. Osmolality Is A Predictor For Model-Based Real Time Monitoring Of Concentration In Protein Chromatography 12/23/2020

    The bottleneck for real time control and real time release is lack of product-specific in-line sensors or fast at-line
    methods suitable for model-based prediction of process outcome. Learn how osmolality as an at-line method is an excellent predictor together with UV280 and UV260 for protein quantity in model-based prediction using partial least squares methodology.

  6. 8 Ways That Osmolality Testing Improves Cell And Gene Therapy Process Development And Manufacturing 12/17/2020

    Gene and cell therapies have the potential to revolutionize the treatment of incurable diseases which are often debilitating, if not fatal. Eight emerging and novel uses for osmolality testing in advanced therapy production are outlined in this white paper.

  7. Reliable Osmolality Testing Of High Concentration mAb Formulations 12/17/2020

    Osmolality testing has several bioprocessing applications, and new use cases are constantly emerging. This paper evaluates two osmometers for measuring concentrated protein formulations. 

  8. The Evolving Role Of The GxP Archivist 12/16/2020

    Customers and regulators expect the highest level of data integrity, and many organizations rely on an archivist to maintain and protect this most important asset. This white paper will assert that storing GLP data in the cloud is acceptable, provided certain conditions are met.

  9. Ensuring Consistency In The Supply Of Cell Culture Media 12/16/2020

    This paper describes a robust, global manufacturing network for cell culture media that supports capacity expansion to meet growing demand and ensure business continuity.

  10. Leading The Edge Of Innovation Into Cell Culture Media Quality 12/16/2020

    In this white paper, we highlight the breadth of programs implemented across our organization to safeguard the quality of the cell culture media that are used in our customer processes.