Downstream Processing White Papers and Case Studies

31. Improving Aggregate Removal From mAb Feed Using Cation Exchange Chromatography

    Researchers in the field of chromatography have required ever more sophisticated and selective methods for removing aggregates from the monomer.

32. Global Biochemical Profiling For Bioprocess Optimization 6/12/2013

    It is widely understood that the production phase of bioprocessing can have a significant impact on the overall profitability of the biopharmaceutical.

33. 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

34. Biomanufacturing Debottlenecking And Process Optimization 3/6/2012

    Optimizing biomanufacturing is particularly challenging because of variability and complexity associated with the sharing of finite and interdependent resources. By BIO-G

35. 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.

36. Automation Of A Homogeneous Proximity Assay For Detection Of Residual Protein A In Biological Therapeutics

    Protein A is used in affinity chromatography for therapeutic antibody purification and has been shown to leach from columns during purification of antibodies resulting in contamination. Residual Protein A in therapeutic drugs could elicit mitogenic or immunological reactions in patients.

37. Efficiency Test Of ReadyToProcess™ Columns 5/1/2013

    ReadyToProcess™ columns are prepacked, prequalified, and presanitized process chromatography columns suited for purification of biopharmaceuticals (e.g., proteins, vaccines, plasmids, and viruses) for clinical phase I and II studies. ReadyToProcess columns are available with several media at different volumes (1, 2.5, 10, and 20 L).

38. Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance 4/24/2012

    Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B).  By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories

39. White Paper: Capillary Electrophoresis — A Simple Technique

    In 1989, Beckman Instruments introduced the first fully automated capillary electrophoresis instrument (P/ACE™ 2000) to the scientific community. At that time, CE demonstrated exceptional resolving of selected compounds, but the new technology lacked a track record of applications. By Beckman Coulter, Inc.

40. Biomanufacturing Complexity 12/22/2011

    This white paper addresses one of the most serious challenges facing biomanufacturing professionals today - how to understand and then deal with the extreme complexity associated with biotechnology manufacturing.