DOWNSTREAM PROCESSING FEATURED ARTICLES
The rate of usage of disposables in biopharmaceutical manufacturing has increased substantially over the past six years in a variety of areas, but most notably for complex devices, that are also among the most expensive. By Eric Langer
-
![Trisha Gladd]( "Merck Assesses Single Use: Does It Make Sense At A Large Scale?")
Merck Assesses Single Use: Does It Make Sense At A Large Scale?In an industry as conservative as the pharmaceutical industry, it is common practice to be adverse to new technologies because they are often viewed as too much of a risk. However, in this effort to play it safe, companies force themselves into a repetitive state of employing technologies that may not be the most efficient or effective. Rather than getting stuck in old habits — or conversely, jumping too quickly into new ones — Merck has put together a group of teams it calls the Technology Encouragement Collaborators, or TEC, to look at new technologies and determine whether or not to implement them.
-
![Service Package Options]( "Making The Switch To Single-Use: Have You Thought Of Everything?")
Making The Switch To Single-Use: Have You Thought Of Everything?In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.
-
![Dr Reddy]( "Dr. Reddy's Laboratories Ltd. And Merck Serono Announce Collaboration To Develop And Commercialize Biosimilars")
Dr. Reddy's Laboratories Ltd. And Merck Serono Announce Collaboration To Develop And Commercialize BiosimilarsDr. Reddy’s Laboratories Ltd. [NYSE:RDY] and Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs). The partnership covers co-development, manufacturing and commercialization of the compounds around the globe, with some specific country exceptions.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
-
Global Biochemical Profiling For Bioprocess Optimization
It is widely understood that the production phase of bioprocessing can have a significant impact on the overall profitability of the biopharmaceutical.
-
![CPC AQ variety (feature)]( "Single-Use Connections Advance Aseptic Processing")
Single-Use Connections Advance Aseptic ProcessingJohn Boehm discusses how single-use connections advance aseptic processing and create increased process flexibility and reliability while reducing costs.
-
![ANAKTAstart]( "Automating Protein Purification Processes Achieves Reliable Results And Reproducibility")
Automating Protein Purification Processes Achieves Reliable Results And ReproducibilityÄKTA start is an easy-to-use, reliable protein purification system. In this application note it is described how Erica, a post-doctoral researcher, used ÄKTA start to purify GST-tagged protein using a predefined method template, a GSTrap FF column, and a Frac30 fraction collector.
-
![Bill whitford]( "Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate")
Continuous Biomanufacturing: 10 Reasons Sponsors HesitateThe industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.
-
Met One Sensors Resistant To Vaporous Hydrogen Peroxide (VHP) Pharmaceutical manufacturers often require an aseptic production environment to minimize the presence of microbes and their potential contamination of the manufactured product.
-
Removal Of Host Cell Proteins During Monoclonal Antibody Purification
Protein A chromatography is a widely used and highly successful method of purifying recombinant monoclonal antibodies. However, since Protein A has high affinity for antibodies, harsh conditions such as low pH are often required to elute monoclonal antibodies from Protein A affinity columns. By 3M Purification Inc
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.
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.