DOWNSTREAM PROCESSING FEATURED ARTICLES

continuous biomanfuacturing Genzyme Pioneering Continuous Manufacturing In Biotech

One company that has made significant progress in the development of a continuous manufacturing platform for large molecule drugs is Genzyme. I recently spoke with Jason Walther, a staff scientist at Genzyme, about the impact of continuous manufacturing on the industry as well as its potential. 

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

  • 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.

  • Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media

    Monoclonal antibodies (mAbs) remain a predominant class of therapeutic protein products on the market because of their wide range of applications in disease treatment and diagnosis. Over the years, upstream technology advancements have helped improve the titer of target antibodies, from merely 1 g/L two decades ago to 10–13 g/L in fed-batch processes and up to 25 g/L in perfusion cultures today (Gronemeyer et al. 2014).

  • Important Considerations For Implementing A Single-Use Biomanufacturing Strategy

    Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC

  • 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.

  • Agilent Microarray Grant Application Support White Paper This guide offers an overview of Agilent’s microarray and SureSelect product offerings with ordering details to assist researchers with the details of grant submission.

DOWNSTREAM PROCESSING PRODUCTS

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.

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

LifeASSURE PNA series filters help bioprocess, pharmaceutical, biologicals, and diagnostic reagent processors meet high standards for microorganism and fine particle control. 

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.

Get fast micro-centrifugation in an easy-to-use, compact design. The Beckman Coulter Microfuge® Series offers the performance and reliability you demand—and have come to expect.  Intuitive user interface display, increased speed and capacity, safety, and multiple rotor options are just a few of the many features the Microfuge® offers.

Capto L is an affinity chromatography medium for the process-scale capture of a broad range of antibodies and antibody fragments.

Our integrated single-use bioreactors are designed as complete out-of-the-box jacketed systems, each paired with an integrated controller and temperature control unit (TCU).

Proyield Pea PCE80B is a protein hydrolysate derived from pea protein concentrate by enzymatic hydrolysis. The enzymes used for digestion are from non-animal sources. Proyield Pea PCE80B has been ultrafiltered to reduce endotoxin.

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