Downstream Processing White Papers and Case Studies

31. Metal Removal From Fine Chemical Products

    Metal contamination in various injectable or even oral medicines is a serious concern.

32. Efficiencies Of Natural Convection In Passive Pallet Shippers

    Bulk transportation of temperature sensitive pharmaceuticals and biologics has become a common practice due to complex global supply chains. By Iftekhar Ahmed, Ben VanderPlas, and Stu Krupnick

33. Chromatography Column Protection With 3M Purification LifeASSURE™ PLA Series Membrane Filters 9/14/2011
    Protective, or guard, filters are often used in chromatography column purification steps to protect the column media from contaminants in the various fluids that come in contact with the column.
34. Sani-Tech® Ultra White Paper 6/29/2012

    For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion. 

35. White Paper: Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications 6/10/2011
    Prior to creating an accurate economic model for TFF, a thorough understanding of the process where the TFF is used is needed. A process model is a valuable tool when properly executed and it must accurately include all critical aspects of the purification process. By Michael LaBreck, Mark Perreault, Novasep
36. A Disposable Valve For Process Chromatography 8/15/2012

    This case study discusses the need for a fully automated, disposable chromatography system which was PLC controlled and designed for use in a cGMP environment. The required applications for the chromatography system included contamination removal, and concentration and purification of biologically derived proteins used in the production of research and clinical materials. 

37. Proven Long Life Lasers™ In Optical Particle Counters 12/1/2011
    Optical particle counters (OPC) utilize light illumination and extinction to determine the presence, size, number and/or concentration of particles. Particles are typically suspended in a fluid or air, which flow through the volume that is illuminated and viewed by the detection system.
38. A Purification Strategy For Clinical-Grade Monoclonal Antibody 10/3/2016

    mAbs are currently the most important class of therapeutic proteins. Advances in upstream process technologies have led to tremendous improvement of mAb titers in mammalian cell culture. 

39. 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

40. USP <787> Small Volume Testing With Liquid Particle Counters

    By their very nature, biological therapeutics are not only expensive to manufacture but are often produced in small volumes.