Servier, the independent international pharmaceutical company, and MaSTherCell SA, the full-service contract development and manufacturing organization (CDMO) specializing in the delivery of optimized process industrialization capacities to cell therapy organizations, today announced the signing of a master service agreement for the development of a manufacturing platform for allogeneic cell therapies. Under the master service agreement, MaSTherCell is developing a CAR-T cell therapy manufacturing platform, which will enable industrial and commercial manufacturing of Servier cell therapy products. This is a critical…
Author Archives: BPI Contributor
Improving Protein Folding Control and Scalability Using imPULSE Mixing Technology
This webcast features: Anthony Hawrylechko, Director of Microbial Bioprocess, Cytovance Protein folding by dilution is a common approach used in the manufacturing of biologics derived from microbial expression systems. This typically involves the solubilization of a washed inclusion body preparation containing the concentrated product polypeptide with a strong chaotrope or detergent solution. The denatured, inactive product solution is then diluted into a combination pH and red/ox buffer solution. Within this environment, the molecular diffusion rates of chaotrope, buffer components, and…
Vetter Starts Operations in its Center for Visual Inspection and Logistics
Vetter, a leading global Contract Development and Manufacturing Organization (CDMO) for development, aseptic filling and final packaging of injectables, has announced today that it has begun operations in its expanded Visual Inspection and Logics Center located in Ravensburg. The enlargement, in which the company invested approximately 100 million euros ($107 million), bundles capacity for final product inspection and logistics in one cutting-edge site. By finalizing the second construction stage of the site that was initially put into operation five years…
Effective Deployment of OPUS Pre-Packed Chromatography Columns for Bench-Scale Process Development and Process Validation
This webcast features: Tim Schroeder, Director, Product Management at Repligen GmbH Formerly Atoll pre-packed columns, OPUS® pre-packed chromatography columns for process development are used in all steps of downstream development, including screening, process validation and viral clearance, scale up and sample preparation. This webcast will demonstrate how OPUS® ValiChrom Columns, glass pre-packed columns that are exact scale-down models of corresponding full-scale chromatography columns, are ideal for process validation including viral clearance. It will also demonstrate how OPUS® RoboColumns®, miniaturized columns…
MilliporeSigma Launches First Commercial Service to Predict Multiple Sources of DNA Damage
MilliporeSigma has introduced CAN MultiFlowâ„¢ screening services to more accurately predict genotoxic and mode of action* properties of substances, ingredients and drug compounds. Offered through its BioReliance® testing facilities, MilliporeSigma will be the first company to provide this service in the United States. The screening process uses flow cytometry to quickly and efficiently screen for clastogens, aneugens and non-genotoxicants (CAN) in pharmaceutical compounds, agricultural chemicals, flavors, fragrances and consumer products. The results from the assay can help manufacturers reject harmful…
MilliporeSigma Expands End-to-End Biodevelopment Centers in North America, China and Europe
MilliporeSigma, a leading science and technology company, today announced the expansion of its end-to-end biodevelopment centers to meet increasing customer demand for its turnkey portfolio of bioprocessing products, manufacturing capabilities and industry leading technological expertise. The expansion, which includes the opening of two new process development centers in the U.S. and China, follows the commercial success of MilliporeSigma’s biodevelopment center in Martillac, France. The two new units will be located in close proximity to customers in the Shanghai and Boston…
Qosina Adds New Y Connector Hemostasis Valves
Qosina is pleased to announce the addition of four new Y connector hemostasis valves (#80300-#80303) to its product line. Each hemostasis valve is equipped with a rotating male luer lock or male luer slip, and a female luer lock sideport. The Y connector gives the valve an ergonomic design for comfortable handling. The housing is made from a tinted polycarbonate material that minimizes discoloration during the sterilization process. The silicone gasket creates a seal for secure positioning when closed and…
Characterization and Engineering Performance of the Allegroâ„¢ STR 2000 Single-Use Stirred Tank Bioreactor
Process performance in bioreactors is strongly influenced by the efficiency of bulk fluid mixing and the oxygen mass transfer coefficient (kLa). The success of traditional stainless steel STR systems lies in their direct impeller driven agitation that can deliver a wide range of specific power inputs to the fluid. The Allegroâ„¢ range of single-use stirred tank bioreactors has adopted this direct driven impeller technology, which allows a wide range of specific power inputs to be achieved. In addition, modifications to…
Ultimate Flexibility from Pre-Packed to Unpacked: OPUS 45R and OPUS 60R Columns
This webcast features: Fletcher Malcom, Director of Product Management, Repligen With an innovative side port that allows for easy resin unpacking, OPUS® 45R and OPUS® 60R Columns provide the ultimate flexibility in pre-packed column technology. Without compromising chromatographic performance or cleanability, the new feature helps mitigate the risk of implementing pre-packed columns in CGMP settings, and allows for re-use of the unpacked resin in other columns. This webinar covers test results on chromatographic performance, bioburden testing, shipping tests and simple…
Saint-Gobain Opens New Maryland Facility to Manufacture Single-Use Systems for Cell Therapy
Saint-Gobain Performance Plastics’ Life Sciences Division is celebrating its move into the fast-growing cell therapy market with a new state-of-the-art facility that will manufacture specialty disposables for both the cell therapy and biotechnology markets. With material technology combined with expertise in custom design, Saint-Gobain Performance Plastics is uniquely positioned to offer solutions to the numerous challenges faced by cell therapy manufacturers today, contributing to the end goal of delivering effective therapies to more patients. Located in Gaithersburg, Maryland, the new…