DOWNSTREAM PROCESSING FEATURED ARTICLES

Cangene Announces Closing Of Acquisition Of Late Stage Hemophilia B Product

Cangene Corporation (Cangene) today announces the closing of the acquisition of the investigational hemophilia compound IB1001 and certain other assets from Ipsen and Inspiration Biopharmaceuticals, Inc. in connection with Inspiration's bankruptcy proceedings.

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • 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.

  • Efficiency Test Of ReadyToProcess™ Columns

    ReadyToProcess™ columns are prepacked, prequalified, and presanitized process chromatography columns suited for purification of biopharmaceuticals (e.g., proteins, vaccines, plasmids, and viruses) for clinical phase I and II studies. ReadyToProcess columns are available with several media at different volumes (1, 2.5, 10, and 20 L).

  • Top 10 Considerations When Selecting An Isolator Supplier

    While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier.

  • 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

  • Cultivation Of Human CAP Cells: Evaluation Of Scale-Down Capabilities

    The following application note illustrates how the DASbox Mini Bioreactor System combined with the BioBLU 0.3c single-use vessels supports bioprocess development in human cell culture.

  • 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

DOWNSTREAM PROCESSING PRODUCTS

LifeASSURE SP series sterilizing grade filters and capsules are validated for absolute bacteria retention and provide reliable sterile filtration performance.

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. 

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.

The Pyros Kinetix® Flex is an optical tube reader that runs both chromogenic and turbidimetric assays in compliance with the USP, EP, and JP bacterial endotoxin test chapters.
The electro-optical module EOM-O2-mini is a precise OEM solution for non-invasive oxygen sensor spots. Assembled according to ISO 9001:2000 they deliver certified quality.

Elevating your laboratory’s potential starts with the optimal tabletop ultracentrifuge. And the Optima MAX Series is the absolute top of the line. Reaching up to 150,000 rpm and over 1,000,000 x g, Optima MAX instruments set the standard in tabletop speed.

High throughput and high productivity are standard fare for every Beckman Coulter centrifuge and the Avanti JXN Series is no exception. It’s more than capable of delivering solutions for shared labs, GMP environments, networked instruments and more.

ReadyToProcess ULTA normal flow filter capsules are single-use filters designed for laboratory through process scale applications. Cytiva provides filtration solutions and support for integrated bioprocessing applications at every step and every scale of the drug development, validation and manufacturing process.

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