DOWNSTREAM PROCESSING FEATURED ARTICLES

iStock-478554068 Update On Advanced Rapid Microbiology Methods In Biopharma

A BioPhorum survey of biopharma end-users reveals the opportunity—and the challenge—involved in the adoption of advanced rapid microbiology methods. Audrey Chang, global head of development services at BioReliance Merck; Morven McAlister, senior director at Pall Biotech; and Scott Hooper, associate director at Merck & Co Inc. break down the data.

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

  • 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

  • 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.

  • 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.

  • Connection Technology Advances Closed System Processing

    The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company

  • Biomanufacturing Supply Chains

    This white paper examines the major issues with biopharmaceutical supply chains and how to balance inventory and risk optimally in the network.

DOWNSTREAM PROCESSING PRODUCTS

3M Purification's core filtration technologies address the most demanding applications in pharmaceutical processing for small molecule and active pharmaceutical ingredient (API) applications.

The Hamilton PRP™-C18 is a new HPLC column designed to provide high-efficiency, reversed-phase separations over an extended column life in nearly any mobile phase or pH.

Encompassing two leading-edge processes, multi-zone microporous membrane construction and Advanced Pleating Technolog (APT) design, LifeASSURE™ PSA Series filters offer robust 0.20 and 0.10 micron absolute-rated filtration and exceptionally long service life.

With the Eppendorf BioSpectrometer basic, measurements can be executed in the UV and Vis range from 200 nm to 830 nm. The freely selectable wavelengths offer you maximum flexibility during these procedures.

Mixed-mode chromatography resin is a top tier selection for the manipulation, purification and handling of molecules; providing an unmatched level of separation properties and resolution. The combination of cation exchange resin and metal affinity resin properties, allows multimodal chromatography to provide an access route for biomolecules to separate and the use of alternative chromatographic methods make these biomolecules seem homogenous.

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.

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.

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

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