DOWNSTREAM PROCESSING FEATURED ARTICLES
Repligen Corporation announced recently that it has acquired the business of Refine Technology (“Refine”), including Refine’s Alternating Tangential Flow (“ATF”) System, a market-leading device used to significantly increase product yield during the fermentation step of the biologic drug manufacturing process.
-
Ablynx's Anti-IL-6R Nanobody, ALX-0061, Shows Excellent 24 Week Safety And Efficacy Results In A Phase II Clinical Trial In Rheumatoid Arthritis
Ablynx (EURONEXT BRUSSELS: ABLX) today announced efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
-
Immunovative, Inc. Announces Expanded Collaboration With The University Of Arizona To Investigate AlloStim™ And AlloVax™ In Leukemias And Cancers That Affect Children
Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) has today announced that Immunovative Therapies, Ltd. ("ITL") and The University of Arizona Cancer Center (UACC) and The University of Arizona Medical Center (UAMC) (University Campus and Diamond Children's) have agreed to expand their current collaboration to include investigator-initiated clinical trials using AlloStim™ and AlloVax™, with an initial focus on adult and pediatric leukemias and childhood cancers that are refractory to standard treatments.
-
FDA Reports Conditions Observed At New England Compounding Center Facility
Recently, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
-
White Paper: Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
-
![Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media]( "Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media")
Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography MediaMonoclonal 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).
-
Sani-Tech® Ultra White Paper
For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion.
-
Metal Removal From Fine Chemical Products
Metal contamination in various injectable or even oral medicines is a serious concern.
-
Biomanufacturing Complexity
This white paper addresses one of the most serious challenges facing biomanufacturing professionals today - how to understand and then deal with the extreme complexity associated with biotechnology manufacturing.
-
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
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.
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.