Bioprocessing White Papers

  1. Pharmaceutical Production Technology Transfers: Reaping Rewards, Reducing Risks
    7/24/2017

    There are a number of strategic advantages companies can achieve in pharmaceutical production by transferring production between sites. They can safeguard supply by producing at more than one site, and improve distribution by moving production closer to critical markets. They can also reduce program costs and risks by moving production to sites that are better qualified, can produce more economically, or are better positioned to meet the needs of regulators.

  2. Best Practices In Formulation And Lyophilization Development
    7/19/2017

    The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary structure, without unintended chemical modifications, and free of extrinsic and intrinsic particles. In many cases, a lyophilized formulation can provide the highest probability of technical success. A well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.

  3. Test Parameters For The Leak Test Of Single-Use Systems With The Palltronic® Flowstar LGR Instrument
    6/30/2017

    Leak testing of SUS or biocontainers, post-installation and prior to actual use, reduces the risk that a system or a biocontainer which may have been damaged during shipping, receiving, handling, storage, or installation could contribute to valuable product loss. Therefore, in cases involving high value product or complex multiple operations, leak testing may be recommended prior to use at the end-user site. This document serves to provide general guidance for experimentally establishing leak test maximum  flow for SUS tested at the end-user site. It is intended to assist users in the development of parameters and maximum flow for the leak test of single-use systems when using the Palltronic Flowstar LGR test instrument.

  4. Accelerate Flavivirus Vaccine Production With Modern Tools And Solutions
    6/11/2017

    This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production.

  5. Managing Risk In Biomanufacturing
    6/6/2017

    Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.

  6. Blow-Fill-Seal For Biologics: Breaking Through In Pharma Packaging
    5/3/2017

    As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs. 

  7. Planning And Executing Cycle Development For The Vapor Hydrogen Peroxide Decontamination Of A Filling Line Isolator
    4/6/2017

    The cycle development approach described in this document is fairly universal and should not be dependant on individual isolator systems. The terminology used may be slightly different depending on the technology.

  8. Broaden Analysis Of Compound Factors For Predictive Solubility Solutions
    3/2/2017

    Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

  9. Purification Of Mammalian Virus In A Single Step
    2/28/2017

    Viruses can infect mammalian cells and cause diseases such as influenza, hepatitis, yellow fever, smallpox, and AIDS. Since some biotherapeutic products are produced using mammalian cell lines or plasma, the risk of viral contamination in these products is a concern and guidelines have been enforced to alleviate this risk. Chromatographic separation of viral particles from process intermediates is a key part of ensuring viral safety in biotherapeutics (ICH Expert Working Group 1999, Moritz 2005). Additionally, purification of viral particles is used extensively in the study and characterization of these infectious agents.

  10. Streamlining Change Control In Today’s Complex Life Sciences Organizations
    1/11/2017

    Change control is collaborative, iterative and labor-intensive. For any specific change event, multiple users are required to follow a prescribed set of tasks and processes, which need to be carried out in a defined sequence and are subject to multiple stages of review and approval. It’s very easy to lose track of where you are in the process, what actions need to be completed next, who owns them, and when they are due. Yet the consequences of such lapses can be very costly. This paper examines why it is absolutely vital for organizations to take a comprehensive, closed-loop approach to automating change management, spanning all areas of the organization and extending throughout the product lifecycle.