With pressures mounting to reduce production costs at many companies, and protein A being the most expensive resin used in mAb purification, the use of a high capacity protein A resin can significantly impact the overall cost of doing business. This report details how using a high capacity protein A resin will reduce production costs, on a per-gram produced basis, for companies that implement its use in their chromatography platform.
Author Archives: BPI Contributor
New Bioreactor Tubing Kits from AdvantaPure Speed Turnaround and Increase Processing Capacity
AdvantaPure announces the availability of tubing kits custom made for use with benchtop bioreactors. Bioreactor Tubing Kits consist of Single-Use tubing, preassembled with filters and connectors, at tubing lengths specified by the customer for harvest, vent, sparge and addition lines. “Using preassembled kits offers a number of advantages to customers,†notes Tony Butler, Manager of Single-Use Applications. “They’re built to order from Single-Use tubing – platinum cured silicone or AdvantaFlex(R) TPE – and other customer-specified components. The customer gets exactly…
CYTAGâ„¢ TotalCGH Labeling Kit for CGH+SNP Arrays
Strengthening our position as leaders in the field of molecular biology with expertise in labeling and detection, Enzo Life Sciences now offers the CYTAGâ„¢ TotalCGH Labeling Kit for CGH+SNP arrays. Array-based Comparative Genomic Hybridization (aCGH) is a well-established method for investigating copy number variations and is used to detect a variety of genomic gains and losses ranging from duplications and deletions, unbalanced translocations, and aneuploidies. CGH is a robust method to detect chromosomal abnormalities and enables rapid screening of the…
QuaDrum® Mixing Systems
Meissner’s QuaDrum® rigid outer containers (ROCs) are now available for rehydration and mixing applications. A new accessory retaining lid, stainless steel dolly and true bottom drain option on the QuaDrum® allow the ROC to deliver enhanced recirculation based mixing functionality for process volumes between 50 and 200 L. The new retaining lid option for mixing applications not only provides access to fluid paths located on the top of the biocontainer, but can also positively locate and support a 3†TC…
Future Immunoassay Approaches in Modern Bioprocess Development
Modern bioprocess development requires accurate, high throughput analytical methods to match scaled-down, high-throughput screening, the application of DoE, and science-based decision making consistent with QbD. Gyrolabâ„¢ systems and Gyros’ immunoassay kits constitute a proven platform that supports these needs today and has the capability to meet future challenges. The assay principle uses high-capacity, flow-through affinity columns embedded within a CD. Centrifugal force, capillary action and hydrophobic barriers are exploited during parallel processing of up to 112 samples on each CD.…
Eliminating the Ups and Downs of Staffing Challenges
This webcast features: Beth DiPaolo, M.A., SPHR, President, Eurofins Lancaster Laboratories Professional Scientific ServicesSM Many pharmaceutical and biopharmaceutical companies are currently experiencing strong development pipelines, but they face challenges associated with balancing the expanded workloads with restrictions on employee headcounts. To combat this, companies often turn to temporary staffing; however, due to the challenges in finding, training, and retaining motivated talent, the temporary staffing model does not meet current demands in these areas. As an expert with 14 years of…
Purolite Announces Large Scale Agarose Manufacturing Plant Investment
Purolite Life Sciences today announced a new state of the art facility that will produce agarose resins based on technology developed at Llantrisant, which is Purolite’s R&D Centre of Excellence. Agarose resins are an integral technology used by pharmaceutical developers in the manufacture of modern monoclonal medicines targeting the treatment of cancer, rheumatoid arthritis and well known age related diseases. The market MAbs continues to grow, with worldwide revenues in 2015 exceeding $85 billion. For 35 years Purolite, a US…
Hovione and Vertex Partner in Continuous Manufacturing
Hovione today announced that it plans to host and operate a commercial-scale continuous manufacturing facility as part of an agreement with Vertex Pharmaceuticals. The state-of-the-art facility will be installed in Hovione’s New Jersey location, and Hovione expects the project to be complete by the end of 2017 to support the future manufacturing of Vertex’s approved medicines. Continuous manufacturing represents an innovative shift from the traditional multi-step, multi-location batch production process, which can take up to four weeks or more to…
AdvantaPure Introduces BioClosure System Assemblies that Reduce Assembly Time and Protect Product Integrity
AdvantaPure now offers its BioClosure container closures, made from AdvantaFlex(R) biopharmaceutical grade TPE, as standard, ready-to-use, closed systems. Called BioClosure System Assemblies, they feature a robust design with elastomeric seals against the containers and unobstructed fluid paths. Applications include aseptic sampling, cell growth, filling, process R&D and cold storage. “Customers need high quality, Single-Use systems that protect their products and reduce the risk of contamination,†said Lawrence Morano, Global Sales Manager. “BioClosure System Assemblies are the ideal choice for many…
Sartorius Stedim BioOutsource Contract Testing Facility in Glasgow Successfully Passes FDA Inspection
Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, is pleased to announce that the Glasgow facility of its subsidiary Sartorius Stedim BioOutsource Ltd. has successfully passed an inspection by the U.S. Food and Drug Administration (FDA). In January 2016, the FDA Compliance Safety Officer spent two days at BioOutsource’s facility reviewing its quality systems and their application to the analytical services that support the testing of biologics, vaccines and biosimilars. The inspection confirmed that the Glasgow…