DOWNSTREAM PROCESSING FEATURED ARTICLES

GettyImages-1147006093 Cleanroom Clean White Facility The Real Threat To Biopharma Supply Chains: Bioprocessing Materials

The COVID-19 induced risk to biopharma is not a shortage of pharmaceutical ingredients. It’s the constricting supply of consumable materials and equipment necessary to produce therapies from them. Mike Piccarreta, Partner at Kearney, offers an outlook and practical advice on supply stabilization in this BioProcess Online exclusive. 

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

  • White Paper: Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications Prior to creating an accurate economic model for TFF, a thorough understanding of the process where the TFF is used is needed. A process model is a valuable tool when properly executed and it must accurately include all critical aspects of the purification process. By Michael LaBreck, Mark Perreault, Novasep
  • Biomanufacturing Debottlenecking And Process Optimization

    Optimizing biomanufacturing is particularly challenging because of variability and complexity associated with the sharing of finite and interdependent resources. By BIO-G

  • 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.

  • 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. 

  • 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

Storage of pharmaceutical compounds is a function of the storage process and not a specific containment driven requirement per se. This is the case whether you are processing in a contained fashion or performing non-contained processing into open kegs with simple drum liners.

The Emphaze Hybrid Purifier is a new single-use clarifying device containing a multi-mechanism all synthetic Q-functional anion exchange media integrated with a fine particle, bioburden reduction membrane. The anion exchange media is comprised of a quaternary amine hydrogel supported by a fine fiber nonwoven scaffold. A combination of 3M technology platforms enables the hyperfunctionalization of a high purity polypropylene nonwoven with a covalently attached, thermally stable, water soluble polymer; the functional polymer accounts for roughly two-thirds of the mass of the anion exchange media. The bioburden reduction membrane is a highly asymmetric, high loading capacity polyamide membrane which has nine zones of decreasing pore size spanning a roughly 20X range and terminating with a 0.2 μm bioburden reduction rated pore size.

Designed with a smaller footprint so it will fit right in your lab, the Avanti J-E is compact yet powerful. The Avanti J-E’s extensive rotor library maximizes capacity and optimizes g-force for efficient, fast separations and greater variety of applications. Its high-torque, switched reluctance (SR) drive technology delivers faster acceleration and deceleration, which means less wait time for you. It offers an intuitive, user-friendly interface, as well as lower energy costs. What’s more, the Avanti J-E’s low height and contoured front panel help ease the burden of rotor installation and retrieval, for even more convenient operation.

The Aquasyn tank bottom valve is a reliable solution for your tank outlet needs, with its conical profile allows for complete drainability and the prevention of deadlegs or entrapment areas.

New C-Flex® ULTRA pump tubing is the latest addition to the C-Flex family of thermoplastic elastomer (TPE) tubing. Specifically designed to meet the critical demands of the biopharmaceutical industry, C-Flex® ULTRA outperforms all other TPE materials on the market today.

The Avanti J-30I High-Performance Centrifuge System gives you the fastest separations possible - in the shortest amount of time. Swinging-bucket and fixed-angle rotors provide maximum separation forces in excess of 100,000 x g at speeds up to 30,000 rpm.

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.

Nuvia media are a family of ultra high capacity ion exchangers designed for optimal performance in bioprocessing workflows.

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