DOWNSTREAM PROCESSING FEATURED ARTICLES
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.
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Researchers Discover Blood Biomarker For Lou Gehrig's Disease, Could Lead To New Treatments
Researchers from Brigham and Women's Hospital (BWH) are the first to discover that changes in monocytes (a type of white blood cell) are a biomarker for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease.
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GeoVax Announces Enrollment Completion For Phase 1/2 Clinical Trial For HIV/AIDS Therapeutic Vaccine
GeoVax Labs, Inc. (OTCQB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, announced it has completed enrollment in a nine-patient Phase 1/2 clinical trial testing the safety, immunogenicity and ability of its DNA/MVA vaccine to elicit protective immune responses in HIV-infected individuals.
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NeoStem's Subsidiary, Progenitor Cell Therapy, Enters Into A Cell Therapy Manufacturing Services Agreement With Adaptimmune
NeoStem, Inc. and its subsidiary, Progenitor Cell Therapy LLC ("PCT"), together with Adaptimmune Limited and Adaptimmune LLC (collectively, "Adaptimmune"), announced recently a Services Agreement under which PCT will provide services to support Adaptimmune's NYESO-1c259-T cell therapy product being developed for multiple oncology indications (for more information with respect to Adaptimmune's clinical trials, see clinicaltrials.gov, identifiers NCT01350401, NCT01343043 and NCT01352286).
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Avoiding Drug Shortages With Microbial Detection
Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. By Aric Meares, President and CEO, BioVigilant
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Quality By Design In Biomanufacturing
QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.
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An Automated Profiling Application For G9a Histone Methyltransferase And Bromodomain Proteins
Due to several findings, G9a and BET bromodomain proteins have become the target for numberous drug discovery projects. In this study, we describe a novel, cell-based assay platform that uses the robust, yet simple Enzyme Fragment Complementation (EFC) Technology.
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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.
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Materials Of Construction For Biopharmaceutical Water Systems
Stainless steels are uniquely qualified for bioprocessing applications not only because of their long service life, availability, and fabricability, but also because they are non-corroding, non-contaminant, can be polished to very smooth finishes, are strong and rigid, can withstand heat and chemical sterilization treatments, and are easily welded. By Michelle M. Gonzalez
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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.
DOWNSTREAM PROCESSING PRODUCTS
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.
Time-to-clinic and time-to-market are two key factors in successful biopharmaceutical development.
Cytiva provides filtration solutions and support for integrated bioprocessing applications at every step and every scale of the drug development, validation and manufacturing process.
Capto Core 700 is a multimodal chromatography medium designed for purification of large proteins or viruses in vaccine processes.
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.