DOWNSTREAM PROCESSING FEATURED ARTICLES

How Can You Mitigate The Risks Of Single-Use Bags? How Can You Mitigate The Risks Of Single-Use Bags?

The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • 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

  • 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).

  • Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite Media

    CHT ceramic hydroxyapatite media require specific considerations during process-scale chromatography packing due to high specific gravity, rapid settling rate, and sensitivity to mechanical shear.

  • Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System

    This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.

  • White Paper: Capillary Electrophoresis — A Simple Technique

    In 1989, Beckman Instruments introduced the first fully automated capillary electrophoresis instrument (P/ACE™ 2000) to the scientific community. At that time, CE demonstrated exceptional resolving of selected compounds, but the new technology lacked a track record of applications. By Beckman Coulter, Inc.

  • Applications And Integration Of Hydrogen Peroxide Vapor For Biotech/Bioprocess

    The increase in size and scale of bio-processing is presenting a new challenge. Traditional methods of sterilisation, to maintain clean facilities, are becoming difficult to deploy in a controlled and regulatory compliant way. By Richard Lucas, Ph.D., Bioquell UK Ltd.

DOWNSTREAM PROCESSING PRODUCTS

STERIS Isomedix Services provides contract sterilization and microbial control services for single-use bioprocess systems used in the production of biopharmaceuticals and vaccines.

This is an exciting platform technology for cell cultivation. It is a highly versatile process which permits great increases in cell and product concentrations as compared to Fed Batch processing.

CHT is a leading purification medium of biomolecules in today’s demanding downstream process industry. Its mixed-mode support offers unique selectivities and often separates biomolecules that appear homogeneous with other chromatographic methods. The diverse binding capabilities of CHT for host cell proteins, leached protein A, antibody dimers and aggregates, nucleic acids, and viruses allow its use at any stage from initial capture to final polishing.

Antibody against Macrophage/Macroglia-specific Protein, Iba1.

PRP-X300 is a polymeric column packing for the separation of alcohols and organic acids.

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.

Get more results with the CHO Media Development Kit, which allows you to create a formulation development strategey that fits with your project timeline, resources, and goals.

Sterilizing grade 0.04um, 0.1um, 0.2um hydrophilic PES membrane filters plus other micron ratings. Single layer or double layer PES and with optional prefilter layers to extend on-stream life. Gamma compatible and suitable PVDF alternative. Mold injected capsules with multiple inlet / outlet options including sanitary ‘T’ clamps, hose barbs, quick sanitary connectors, elbows and threads. Almost any combination of connecting inlet or outlet is possible with over 30 options. Full validation supporting documents are available. Ideal for tube sets and hook up to bioreactors, fermenters, biocontainer, biobags, wave bags or single use fermenters.

ZenPure’s in-company mold design and injection capabilities, filter production and quality assurance facilitate manufacturing audit and product traceability that meet the highest industry standards.

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