DOWNSTREAM PROCESSING FEATURED ARTICLES
The data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production speaks to the industry’s ongoing desires for standardization in single-use devices. As usage of these disposable devices increases, the gap between the importance of standardization and end-users’ satisfaction with their supplier’s standardization efforts has steadily been worsening.
-
Theraclone Sciences Secures $14M In Additional Financing
Theraclone Sciences, Inc., a therapeutic antibody discovery and development company, recently announced a $14M financing. $8M in equity is committed from existing investors ARCH Venture Partners, Canaan Partners, MPM Capital, Healthcare Ventures, Alexandria Real Estate Equities, Amgen Ventures, Versant Ventures and Zenyaku Kogyo in a Series B Extension, bringing the total round to $50M.
-
Is There An Enzyme In Your Future? A method for reducing the chemical steps in vitamin C synthesis from six to two underscores the growing importance of enzymes in organic synthesis...
-
New Strategy Prevents Rheumatoid Arthritis In Mice
Dana-Farber Cancer Institute scientists have demonstrated a new strategy for treating autoimmune disease that successfully blocked the development of rheumatoid arthritis in a mouse model.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
-
How CHT Ceramic Hydroxyapatite Works Application Note
CHT ceramic hydroxyapatite is a versatile chromatography support used for separation of biological molecules as diverse as polyclonal and monoclonal antibodies, antibody fragments, enzymes, nucleic acids, and membrane proteins. By Paul Ng, Jie He, and Andrew Cohen, Bio-Rad Laboratories, Inc., Hercules, CA 94547
-
The Challenge of Measuring Total Organic Carbon In Modern Pharmaceutical Water Systems
Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document from the International Conference on Harmonisation.
-
Mammalian Virus Purification Using Ceramic Hydroxyapatite
Conventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.
-
White Paper: Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells 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.
-
Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance
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
-
Proven Long Life Lasers™ In Optical Particle Counters 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.