Downstream Processing White Papers and Case Studies

1. Metal Removal From Fine Chemical Products

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

2. Effect Of Sterilization On Mechanical Properties Of Silicone Rubbers 6/18/2013

   Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high level energy and/or chemical vapor in order to eliminate bacterial surface contamination.

3. 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

4. Important Considerations For Implementing A Single-Use Biomanufacturing Strategy 10/18/2013

   Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC

5. 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).

6. Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography 10/1/2016

   The first step in purification of an important class of therapeutic proteins, the polyclonal or monoclonal antibodies (mAbs), is their capture from plasma or tissue culture supernatants. Protein A–based media are by far the most common class of affinity products used for this purpose.

7. White Paper: 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.
8. 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.

9. Micro-Volume Determination Of Labeling Efficiency In A Standard Microplate Reader 2/12/2013

   A variety of methods and reagents have been developed to efficiently label biomolecules. By Peter J. Brescia, Applications Scientist,  BioTek Instruments, Inc.

10. An Automated Profiling Application For G9a Histone Methyltransferase And Bromodomain Proteins

    Due to several findings, G9a and BET bromodomain proteins have become the target for numberous drug discovery projects. In this study, we describe a novel, cell-based assay platform that uses the robust, yet simple Enzyme Fragment Complementation (EFC) Technology.