Culture Development White Papers and Case Studies

31. White Paper: Performance Evaluation Of An Automated Bioreactor Sampling System For Mammalian Cell Cultivation 11/4/2008
    Two common goals of biotherapeutics development are reduction in timelines and increased process understanding. An automated bioreactor sampling system developed by Groton Biosystems has proven its capacity to address those two seemingly conflicting needs for the industry. Due to the extreme length and stringent sterility requirement of mammalian cell cultivation, sampling automation of mammalian bioreactors remains an unmet need. By Groton Biosystems
32. Application Note: Rapid Isolation Of Antigen-Specific Clones From Hybridoma Fusions 10/15/2008
    Screening a hybridoma fusion and then subcloning candidate hybrids are time-consuming elements of the monoclonal antibody discovery process. The Genetix ClonePix FL provides a powerful way to find and collect antigen-specific clones in a rapid one-step process. The technology works by automatically screening the entire fusion in situ and isolating only antigen-specific clones with the desired immunoglobulin isotype. If the fusion has many antigen-positive clones, then ClonePix FL can selectively collect only the best secretors. By Genetix Limited
33. Case Study: Manufacture Of A Cell-Based Biologic For The Clinic 7/15/2008
    This case study describes the steps and processes required for the Manufacture Of A Cell-Based Biologic For The Clinic as recently completed by FLorida Biologix, a CGMP Manufacturer located in Alachua, Florida
34. Automated Cross Flow Filtration For Process Development, Filter Screening, And Process Optimization At Small Scales 9/13/2007

    This application note focuses on microfiltration (pore sizes between 0.1 µm and 1 µm). Microfiltration is ideally suited for separation of cultured cells from the growth medium (broth), as well as for sterilization, and contaminant and particle removal in numerous biopharmaceutical processes

35. White Paper: CA19-9 Antigen 6/26/2007
    CA19-9 is a monoclonal antibody generated against a colon carcinoma cell line to detect a monosialoganglioside found in patients with gastrointestinal adenocarcinoma
36. Improving DNA Removal from Bioprocess Purification Processes

    Many new biological drug products produced using recombinant DNA technology, such as monoclonal antibodies, are produced in cell culture. Because therapeutic proteins such as monoclonal antibodies are produced in cell culture, impurities can result from the host cells, or cell substrates. By 3M Purification Inc.

37. Removal Of Host Cell Proteins During Monoclonal Antibody Purification

    Protein A chromatography is a widely used and highly successful method of purifying recombinant monoclonal antibodies. However, since Protein A has high affinity for antibodies, harsh conditions such as low pH are often required to elute monoclonal antibodies from Protein A affinity columns. By 3M Purification Inc

38. Rapid Chemically-Defined Feed Media Development to Improve Simulated Cell Culture Processes

    Implementing an optimized feed medium may be the most effective alternative for modifications to the growth medium in an existing process.

39. Comparison Of Five Cell Culture Media Demonstrating CHO Cell Culture Growth In Batch Or Fed-Batch Process For Commercial Operations

    This case study details a two month, four phase project to design chemically-defined feed media that improved two simulated batch processes utilizing products by SAFC, Life Technologies, Thermo Fisher Scientific, and Irvine Scientific. By Mark C. Arjona, Evan R. Horowitz, Alex A. Jurisch, Jenny Y. Bang, Tom Fletcher, Irvine Scientific

40. Applications And Integration Of Hydrogen Peroxide Vapor For Biotech/Bioprocess

    The increase in size and scale of bio-processing is presenting a new challenge. Traditional methods of sterilisation, to maintain clean facilities, are becoming difficult to deploy in a controlled and regulatory compliant way. By Richard Lucas, Ph.D., Bioquell UK Ltd.