DOWNSTREAM PROCESSING FEATURED ARTICLES

FDA Approves First Drug-Eluting Stent To Treat Peripheral Arterial Disease

The U.S. Food and Drug Administration approved the Zilver PTX Drug-Eluting Peripheral Stent (Zilver PTX Stent), the first drug-eluting stent indicated to re-open a particular artery in the thigh (femoropopliteal artery) when narrowed or blocked as a result of peripheral artery disease (PAD).

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media

    Monoclonal antibodies (mAbs) remain a predominant class of therapeutic protein products on the market because of their wide range of applications in disease treatment and diagnosis. Over the years, upstream technology advancements have helped improve the titer of target antibodies, from merely 1 g/L two decades ago to 10–13 g/L in fed-batch processes and up to 25 g/L in perfusion cultures today (Gronemeyer et al. 2014).

  • 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

  • White Paper: Computrac® Moisture Analysis Made Simple When people aren’t feeling their best they often turn to medicine for relief from the symptoms that are associated with being ill. The public trusts that the products by pharmaceutical companies will not only make them feel better but will also not have harmful side effects.
  • Sani-Tech® Ultra White Paper

    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. 

  • Comparing The Automated Pipetting To Volumetric Glassware And Air Displacement Pipettes

    Analytical sample preparation is used in many industries such as forensics, environmental chemistry, mining, beer and wine fermentation and many others. Concentrated samples are diluted and analyzed via High Performance Liquid Chromatography, Gas Chromatography, Atomic Absorption, and/or Inductively Coupled Plasma Spectroscopy to name a few. Traditionally these samples are prepared using volumetric glassware, syringes and/or pipettes.

DOWNSTREAM PROCESSING PRODUCTS

Sartopure PP2 Cartridges were optimized for the wide range of prefiltration.

AseptiQuik® STC Connectors integrate the AseptiQuik® sterile connector and the Steam-Thru® II SIP connector, giving manufacturers even greater flexibility for hybrid stainless steel and single-use processing. 

The electro-optical module EOM-pH-mini is a precise OEM solution for non-invasive pH sensor spots. Assembled according to ISO 9001:2000 they deliver certified quality.

Conductivity sensors measure the ability of a solution to conduct a current. The higher the concentration of ions in the solution, the higher the conductivity, which is measured in microSiemens (mS).

Complement your gene expression analysis with LOH studies. Confirm your SNP analysis results by sequencing. Combine MLPA genomic results with quantitative gene expression for the full story.

The Avanti® J-HC High Capacity Centrifuge provides you with a complete solution for batch bioprocessing. A maximum of 9 Liters can be spun at speeds of 5,000 rpm and 7,480 x g for greater sample throughput. This allows processing of up to 36 Liters per hour when harvesting bacteria. Enhanced operator safety is provided with disposable HarvestLine System Liners.

Resin are designed specifically for intermediate purification steps that remove host-cell contaminants from partially purified targets using strong or weak hydrophobic interactions. Methacrylate-based beads for protein and nucleic acid purification using hydrophobic interactions are available for purifying compounds that have weak or strong hydrophobic regions.

Proyield Soy SE50MAF-UF is a protein hydrolysate derived from soy protein by enzymatic hydrolysis. The enzymes used for digestion are from non-animal sources. Proyield Soy SE50MAF-UF has been ultrafiltered to reduce endotoxin.

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