Downstream Processing White Papers and Case Studies

1. Selecting The Optimal Resins For Endotoxin Depletion In Process Purification 8/3/2016

   A guide to effectively remove endotoxins with versatile process resins.

2. Biological Contamination Events In Isolators: What Lessons Can Be Learned? 8/17/2012

   Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director

3. Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System 10/24/2013

   This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.

4. Met One Sensors Resistant To Vaporous Hydrogen Peroxide (VHP) 1/11/2012
   Pharmaceutical manufacturers often require an aseptic production environment to minimize the presence of microbes and their potential contamination of the manufactured product.
5. Cultivation Of CHO Suspension Cells And SEAP Expression

   This application note describes the cultivation of CHO suspension cells in the wave-mixed Thermo Scientific HyPerforma Rocker Bioreactor with a maximum working volume of 5 L. 

6. Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

   The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

7. 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

8. Connection Technology Advances Closed System Processing

   The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company

9. Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells 7/11/2011
   Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
10. 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