DOWNSTREAM PROCESSING FEATURED ARTICLES

Ablynx's Anti-IL-6R Nanobody, ALX-0061, Shows Excellent 24 Week Safety And Efficacy Results In A Phase II Clinical Trial In Rheumatoid Arthritis

Ablynx (EURONEXT BRUSSELS: ABLX) today announced efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • Avoiding Drug Shortages With Microbial Detection

    Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. By Aric Meares, President and CEO, BioVigilant

  • Turning Data Into Information

    As biopharmaceutical manufacturing has evolved from small-scale lab production in small flasks to massive commercial production in deep-tank bioreactors, an avalanche of production data has evolved to support it. From individual unit operation skids to distributed control systems and enterprise resource planning tools, biomanufacturing today is buried by the sheer quantity of data coming in from the manufacturing floor.

  • Metal Removal From Fine Chemical Products

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

  • Biological Contamination Events In Isolators: What Lessons Can Be Learned?

    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

  • Chromatography Column Protection With 3M Purification LifeASSURE™ PLA Series Membrane Filters Protective, or guard, filters are often used in chromatography column purification steps to protect the column media from contaminants in the various fluids that come in contact with the column.
  • Automation Of A Homogeneous Proximity Assay For Detection Of Residual Protein A In Biological Therapeutics

    Protein A is used in affinity chromatography for therapeutic antibody purification and has been shown to leach from columns during purification of antibodies resulting in contamination. Residual Protein A in therapeutic drugs could elicit mitogenic or immunological reactions in patients.

DOWNSTREAM PROCESSING PRODUCTS

PreSens offers a new system for measuring oxygen and pH in shake flasks. The SFR – Shake Flask Reader measures rapid and precise in up to 9 shake flasks simultaneously. This novel device is used for microbial cultivations and cell cultures.

The APM is a next generation fluid management solution for single use process systems allowing you to modulate and control flow without having to use your fingers as the control valve.

ÄKTA™ chromatography systems can handle both simple and complex purification tasks and accelerate daily routines. All systems are controlled by UNICORN™ software, a common control platform and user interface for all scales of operation. 

Bio-Simplex™ Sterile Disposable Centrifuge Tubes are ready-to-use cost-effective single-use containers designed for general biopharmaceutical manufacturing applications such as preculture and sampling. 

Cytiva provides filtration solutions and support for integrated bioprocessing applications at every step and every scale of the drug development, validation and manufacturing process.

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).

The Agilent 2100 Bioanalyzer is a microfluidics-based platform for sizing, quantification and quality control of DNA, RNA, proteins and cells on a single platform. Results are delivered within 30-40 minutes in automated, high quality digital data.

ARIES™ Smart Balance Rotor automatically corrects for imbalance.

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