DOWNSTREAM PROCESSING FEATURED ARTICLES

Single-Use Standardization: Is It Holding Back The Biopharma Industry?

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.

DOWNSTREAM PROCESSING PRODUCTS

The CESI 8000 High Performance Separation-ESI Module is designed for mass spectrometry applications that analyze charged and polar molecules. Thanks to its robust OptiMS technology, the advantages of Capillary Electrophoresis are now delivered to the mass spectrometer without dilution or disturbance.

Magnosphere™ is a superparamagnetic particle for in vitro diagnostics and bio research applications.

Water for Injection (WFI) Quality Water is the most suitable water available for producing cell culture media, reconstitution of biochemical reagents, and as a final rinse water for critical applications. WFI Quality Water meets both EP and USP grade specifications and is 0.1µm sterile filtered at time of fill.

The SPRIworks Fragment Library Systems have built-in size selection and prepare fragment libraries for all three major next generation sequencing platforms. SPRIworks Systems simplify and automate fragment library construction for the Illumina Genome Analyzers, Roche GS FLX DNA Sequencer and Life Technologies SOLiD Sequencers.

Macro-Prep hydrophobic interaction chromatography (HIC) media are methacrylate-based, 50 µm beads used for protein, polypeptide, enzyme, and nucleic acid purification.

ILC Dover brings a unique history and skill set to the biopharmaceutical industry, particularly single use biopharmaceutical powder handling and containment equipment.

ARC Sensors are the complete solution: innovative premium quality sensors with a robust, direct, and standard interface to the PLC. Hamilton ARC Sensors send a 4-20 mA signal directly to an analog process control system while delivering at the same time the power of digital sensor management.

Choose from ten fixed volume SoftGrip pipettes covering 0.2 µL to 1 mL. All pipettes have color-coded plunger buttons and labels for easy volume identification.

DOWNSTREAM PROCESSING MULTIMEDIA

Bioprocess With The Bozenhardts is back, with a fresh episode packed with advice from Herman and Erich on the selection of filling systems for biopharmas. Listen in as the Bozenhardts give us an update on the process, logistics, and administration trends that are informing filling system decisions today, and offer direction on making choices that will prepare you for the fast-advancing therapies of tomorrow.

Beckman Coulter's Randall Lockner, marketing manager for centrifugation, explains the highlights of the floor model ultracentrifuge, the Optima X Series.

Bio-Rad now offers two very high capacity ion exchangers: Nuvia S, which can be used for capture and/or intermediate polishing; and Nuvia Q, which can be used for intermediate and/or final polishing.

DOWNSTREAM PROCESSING INDUSTRY NEWS