DOWNSTREAM PROCESSING FEATURED ARTICLES
Genetic Immunity (OTCBB: PWRV) is pleased to announce the GMP approval of its manufacturing facility. The development of the GMP manufacturing process and the facility was financed from a $4 million grant received from the Hungarian Office for Innovation and Technology.
-
Forsyth Scientists Define The Bacteria That Live In The Mouth, Throat, And Gut
For the first time, scientists have defined the bacteria that inhabit multiple sites along the healthy human digestive tract in a large number of individuals. To prevent and control bacterial diseases, it is essential to first identify which bacteria are responsible for keeping us in good health.
-
![Untitled]( "Stainless Steel Vial Filling System Developed For Use In Vaccine Facilities")
Stainless Steel Vial Filling System Developed For Use In Vaccine FacilitiesTAP Biosystems (now part of the Sartorius Stedim Biotech Group), a leading supplier of innovative cell culture and fermentation systems for life science applications, recently announced the development of a stainless steel version of the fill-it system, designed for safely dispensing biohazardous materials such as vaccine stocks.
-
A Welcome Predictability
Synthetic biology is the latest and most advanced phase of genetic engineering, holding great promise for helping to solve some of the world's most intractable problems, including the sustainable production of energy fuels and critical medical drugs, and the safe removal of toxic and radioactive waste from the environment.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
-
![A Purification Strategy For Clinical-Grade Monoclonal Antibody]( "A Purification Strategy For Clinical-Grade Monoclonal Antibody")
A Purification Strategy For Clinical-Grade Monoclonal AntibodymAbs are currently the most important class of therapeutic proteins. Advances in upstream process technologies have led to tremendous improvement of mAb titers in mammalian cell culture.
-
USP <787> Small Volume Testing With Liquid Particle Counters
By their very nature, biological therapeutics are not only expensive to manufacture but are often produced in small volumes.
-
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
-
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.
-
Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance
Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B). By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories
-
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
DOWNSTREAM PROCESSING PRODUCTS
ÄKTA™ chromatography systems can handle both simple and complex purification tasks and accelerate daily routines. All systems are controlled by UNICORN™ software, a common control platform and user interface for all scales of operation.
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.