DOWNSTREAM PROCESSING FEATURED ARTICLES
New Hope For Understanding Autism Spectrum Disorders
Researchers from McGill University and the University of Montreal have identified a crucial link between protein synthesis and autism spectrum disorders (ASD), which can bolster new therapeutic avenues. Regulation of protein synthesis, also termed mRNA translation, is the process by which cells manufacture proteins.
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Thermo Fisher Scientific And Immundiagnostik Collaborate To Develop Mass Spectrometry-Based Clinical And Research Tools
Thermo Fisher Scientific, Inc., the world leader in serving science, and Immundiagnostik AG today announced a collaboration to develop novel mass spectrometry-based assays for qualitative and quantitative analysis of proteins and peptides. The goal is development of commercial assays to be widely applicable in research and routine clinical analysis.
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First Patient Treated In Genelux Phase I Trial With GL-ONC1 At Memorial Sloan Kettering Cancer Center
Genelux Corporation, a clinical-stage biopharmaceutical company developing vaccinia virus-based cancer therapies and companion diagnostics, today announced that researchers at Memorial Sloan Kettering Cancer Center (MSKCC) in New York treated the first patient in a Phase I clinical trial of GL-ONC1 in people with malignant pleural effusion, a complication that occurs in about 30 percent of lung cancers.
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CDER-ETP: A Resource For Innovative Biopharma Firms
The FDA’s Center for Drug Evaluation and Research’s Emerging Technology Program (CDER-ETP), is yet another step toward removing slow-moving bureaucracy and red tape that stands in the way of innovative new technologies that drive drug development.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Efficiency Test Of ReadyToProcess™ Columns
ReadyToProcess™ columns are prepacked, prequalified, and presanitized process chromatography columns suited for purification of biopharmaceuticals (e.g., proteins, vaccines, plasmids, and viruses) for clinical phase I and II studies. ReadyToProcess columns are available with several media at different volumes (1, 2.5, 10, and 20 L).
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How CHT Ceramic Hydroxyapatite Works Application Note
CHT ceramic hydroxyapatite is a versatile chromatography support used for separation of biological molecules as diverse as polyclonal and monoclonal antibodies, antibody fragments, enzymes, nucleic acids, and membrane proteins. By Paul Ng, Jie He, and Andrew Cohen, Bio-Rad Laboratories, Inc., Hercules, CA 94547
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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
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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.
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Biomanufacturing Flexibility
This white paper from BIO-G looks at how to create flexible, agile manufacturing facilities to respond to the current glut of biomanufacturing capacity and industry consolidation. Future proofing these facilities for higher titers and multiple product lines is also explored.
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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