DOWNSTREAM PROCESSING FEATURED ARTICLES
AdvantaPure®'s BioPharm Tubing And Single-Use Systems To Be Featured At Upcoming Fall Shows
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International Stem Cell Corporation Demonstrates Positive Animal Efficacy Results In Metabolic Liver Disease Program
International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) ("ISCO" or "the Company") a California-based biotechnology company, today announced the conclusions from its study demonstrating the efficacy and safety of the hepatocyte-like cells (HLC) derived from human parthenogenetic stem cells (hpSC) in a well-established animal model of a congenital liver disorder associated with bilirubin metabolism.
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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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Aeras Signs Agreement With GSK To Jointly Advance TB Vaccine
Aeras announces that it has signed an agreement with GlaxoSmithKline Vaccines, S.A. (GSK) to jointly advance the clinical development of an investigational tuberculosis (TB) vaccine containing GSK’s proprietary M72 antigen and AS01E adjuvant.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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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.
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Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers
Increasingly precise process control strategies, often linked to computer control, have accelerated the use of sophisticated on-line chemical composition analyzers in plant applications. Instruments such as gas and liquid chromatographs, ion chromatographs, laser optic instruments, atomic absorption instruments and specific ion analyzers, which were rarities in laboratories ten years ago, are now found routinely in plant settings. By Ken Perrotta, Division Engineering Manager
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Comparison Of Five Cell Culture Media Demonstrating CHO Cell Culture Growth In Batch Or Fed-Batch Process For Commercial Operations
This case study details a two month, four phase project to design chemically-defined feed media that improved two simulated batch processes utilizing products by SAFC, Life Technologies, Thermo Fisher Scientific, and Irvine Scientific. By Mark C. Arjona, Evan R. Horowitz, Alex A. Jurisch, Jenny Y. Bang, Tom Fletcher, Irvine Scientific
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Biological Contamination Events In Isolators: What Lessons Can Be Learned?
Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director
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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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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